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Trial record 83 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects

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ClinicalTrials.gov Identifier: NCT01314261
Recruitment Status : Completed
First Posted : March 14, 2011
Results First Posted : January 26, 2015
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Chronic Hepatitis C
Hepatitis C Virus (HCV) Infection
Interventions Drug: ABT-267
Drug: Pegylated interferon (pegIFN)
Drug: Ribavirin (RBV)
Other: Placebo for ABT-267
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ABT-267 (5 mg) Once Daily + pegIFN/RBV ABT-267 (50 mg) Once Daily + pegIFN/RBV ABT-267 (200 mg) Once Daily + pegIFN/RBV Placebo + pegIFN/RBV
Hide Arm/Group Description Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Period Title: Overall Study
Started 9 9 10 9
Discontinued ABT-267 or Placebo 1 0 1 0
Discontinued pegIFN/RBV 1 4 5 1
Completed 7 5 7 6
Not Completed 2 4 3 3
Reason Not Completed
Adverse Event             1             0             0             0
Withdrawal by Subject             0             3             1             0
Lost to Follow-up             1             0             2             2
Virologic Failure             0             1             0             1
Arm/Group Title ABT-267 (5 mg) Once Daily + pegIFN/RBV ABT-267 (50 mg) Once Daily + pegIFN/RBV ABT-267 (200 mg) Once Daily + pegIFN/RBV Placebo + pegIFN/RBV Total
Hide Arm/Group Description Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. Total of all reporting groups
Overall Number of Baseline Participants 9 9 10 9 37
Hide Baseline Analysis Population Description
All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy and safety analyses.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 9 participants 10 participants 9 participants 37 participants
50.1  (11.32) 49.2  (9.55) 46.0  (10.26) 48.1  (12.32) 48.3  (10.55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 10 participants 9 participants 37 participants
Female
5
  55.6%
2
  22.2%
4
  40.0%
4
  44.4%
15
  40.5%
Male
4
  44.4%
7
  77.8%
6
  60.0%
5
  55.6%
22
  59.5%
1.Primary Outcome
Title Percentage of Participants With 4-week Rapid Virologic Response (RVR)
Hide Description Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Rapid virologic response was defined as HCV RNA levels < the lower limit of detection (< 15 IU/mL) at Week 4. Data are reported as percentage of participants with RVR.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy and safety analyses.
Arm/Group Title ABT-267 (5 mg) Once Daily + pegIFN/RBV ABT-267 (50 mg) Once Daily + pegIFN/RBV ABT-267 (200 mg) Once Daily + pegIFN/RBV Placebo + pegIFN/RBV
Hide Arm/Group Description:
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Overall Number of Participants Analyzed 9 9 10 9
Measure Type: Number
Unit of Measure: percentage of participants
33.3 55.6 70.0 22.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABT-267 (5 mg) Once Daily + pegIFN/RBV, Placebo + pegIFN/RBV
Comments Ten participants in an ABT-267 arm and nine participants in the placebo arm would provide 84% power using Fisher's exact test with two-sided significance level of 0.05 to detect a difference of approximately 70% between the two arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.336
Comments No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.
Method Regression, Logistic
Comments Treatment group, baseline HCV RNA level, HCV subgenotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABT-267 (50 mg) Once Daily + pegIFN/RBV, Placebo + pegIFN/RBV
Comments Ten participants in an ABT-267 arm and nine participants in the placebo arm would provide 84% power using Fisher's exact test with two-sided significance level of 0.05 to detect a difference of approximately 70% between the two arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.171
Comments No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.
Method Regression, Logistic
Comments Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ABT-267 (200 mg) Once Daily + pegIFN/RBV, Placebo + pegIFN/RBV
Comments Ten participants in an ABT-267 arm and nine participants in the placebo arm would provide 84% power using Fisher's exact test with two-sided significance level of 0.05 to detect a difference of approximately 70% between the two arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.
Method Regression, Logistic
Comments Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.
2.Primary Outcome
Title Maximum Plasma Concentration (Cmax) of ABT-267
Hide Description Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the plasma after administration in a dosing interval. The Cmax of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
Time Frame Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.
Arm/Group Title ABT-267 (5 mg) Once Daily + pegIFN/RBV ABT-267 (50 mg) Once Daily + pegIFN/RBV ABT-267 (200 mg) Once Daily + pegIFN/RBV
Hide Arm/Group Description:
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Overall Number of Participants Analyzed 9 9 9
Mean (Standard Deviation)
Unit of Measure: ng/mL
10.7  (3.73) 148  (80.8) 535  (160)
3.Primary Outcome
Title Time to Maximum Plasma Concentration (Tmax) of ABT-267
Hide Description Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
Time Frame Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.
Arm/Group Title ABT-267 (5 mg) Once Daily + pegIFN/RBV ABT-267 (50 mg) Once Daily + pegIFN/RBV ABT-267 (200 mg) Once Daily + pegIFN/RBV
Hide Arm/Group Description:
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Overall Number of Participants Analyzed 9 9 9
Mean (Standard Deviation)
Unit of Measure: Hours
3.3  (1.0) 3.8  (1.6) 4.2  (1.6)
4.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-267
Hide Description Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit. The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The area under the plasma concentration -time curve (AUC; measured in ng*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma. The AUC24 of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.
Time Frame Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.
Arm/Group Title ABT-267 (5 mg) Once Daily + pegIFN/RBV ABT-267 (50 mg) Once Daily + pegIFN/RBV ABT-267 (200 mg) Once Daily + pegIFN/RBV
Hide Arm/Group Description:
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Overall Number of Participants Analyzed 7 3 4
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
115  (35.5) 2200  (1090) 6130  (675)
5.Primary Outcome
Title Plasma Concentrations of Ribavirin (RBV)
Hide Description Blood samples were collected at each study visit from Week 1 to Week 12. The samples were analyzed for the concentration of RBV (measured in ng/mL) using validated analytical methods and RBV concentrations in plasma were summarized at each visit. Data are reported as the median (range).
Time Frame At each study visit from Week 1 to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. When a different number of participants at a specific time point was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.
Arm/Group Title ABT-267 (5 mg) Once Daily + pegIFN/RBV ABT-267 (50 mg) Once Daily + pegIFN/RBV ABT-267 (200 mg) Once Daily + pegIFN/RBV Placebo + pegIFN/RBV
Hide Arm/Group Description:
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Overall Number of Participants Analyzed 9 9 10 9
Median (Full Range)
Unit of Measure: ng/mL
Week 1
1330
(852 to 3950)
1470
(847 to 2700)
1060
(742 to 1700)
1190
(860 to 2130)
Week 2
1890
(484 to 6160)
1640
(328 to 3810)
1420
(1140 to 2150)
1360
(1130 to 2740)
Week 4 (n=8, 8, 10, 9)
1900
(1110 to 4500)
1680
(279 to 3290)
1580
(1250 to 2110)
1950
(842 to 3520)
Week 6 (n=8, 9, 9, 9)
2000
(1390 to 3250)
1510
(0.00 to 3210)
1780
(890 to 2280)
1900
(1380 to 4300)
Week 8 (n=8, 9, 9, 9)
2080
(712 to 3400)
1710
(277 to 3160)
1650
(1120 to 2290)
2280
(277 to 4630)
Week 12 (n=8, 9, 9, 9)
2510
(1300 to 4320)
1740
(0.00 to 2240)
1800
(1270 to 2590)
1940
(0.00 to 4760)
6.Primary Outcome
Title Serum Concentrations of Pegylated Interferon (pegIFN)
Hide Description Blood samples were collected at each study visit from Week 1 to Week 12. The samples were analyzed for the concentration of pegIFN (measured in ng/mL) using validated analytical methods and pegIFN concentrations in serum were summarized at each visit. Data are reported as the median (range).
Time Frame At each study visit from Week 1 to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. When a different number of participants at a specific time point was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.
Arm/Group Title ABT-267 (5 mg) Once Daily + pegIFN/RBV ABT-267 (50 mg) Once Daily + pegIFN/RBV ABT-267 (200 mg) Once Daily + pegIFN/RBV Placebo + pegIFN/RBV
Hide Arm/Group Description:
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Overall Number of Participants Analyzed 9 9 10 9
Median (Full Range)
Unit of Measure: ng/mL
Week 1
7.50
(2.08 to 13.4)
6.12
(2.26 to 9.83)
4.30
(0.00 to 13.9)
4.83
(2.09 to 20.0)
Week 2
8.75
(4.00 to 24.4)
9.22
(4.64 to 14.4)
7.52
(0.00 to 20.1)
6.87
(1.04 to 16.4)
Week 4 (n=9, 9, 10, 9)
11.8
(2.97 to 26.2)
7.72
(3.07 to 16.1)
8.23
(0.00 to 23.4)
8.76
(5.12 to 16.9)
Week 6 (n=8, 9, 9, 9)
10.9
(6.09 to 21.0)
9.35
(5.20 to 15.9)
14.6
(3.59 to 24.1)
10.9
(6.21 to 17.3)
Week 8 (n=8, 9, 9, 9)
9.91
(5.40 to 22.7)
10.1
(2.47 to 15.7)
12.1
(3.94 to 30.3)
11.0
(4.74 to 17.8)
Week 12 (n=8, 9, 9, 9)
14.4
(4.83 to 24.2)
6.16
(0.00 to 15.3)
15.2
(6.39 to 25.6)
8.91
(0.00 to 19.3)
7.Secondary Outcome
Title Percentage of Participants With Partial Early Virologic Response (pEVR)
Hide Description Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Partial EVR was defined as HCV RNA levels that decreased > 2 log10 IU/mL at Week 12 as compared to baseline HCV RNA levels. Data are reported as the percentage of participants with pEVR.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.
Arm/Group Title ABT-267 (5 mg) Once Daily + pegIFN/RBV ABT-267 (50 mg) Once Daily + pegIFN/RBV ABT-267 (200 mg) Once Daily + pegIFN/RBV Placebo + pegIFN/RBV
Hide Arm/Group Description:
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Overall Number of Participants Analyzed 9 9 10 9
Measure Type: Number
Unit of Measure: percentage of participants
100.0 88.9 90.0 77.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABT-267 (5 mg) Once Daily + pegIFN/RBV, Placebo + pegIFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.102
Comments No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.
Method Cochran-Mantel-Haenszel
Comments Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or > median).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABT-267 (50 mg) Once Daily + pegIFN/RBV, Placebo + pegIFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.362
Comments No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.
Method Cochran-Mantel-Haenszel
Comments Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or > median).
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ABT-267 (200 mg) Once Daily + pegIFN/RBV, Placebo + pegIFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.079
Comments No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.
Method Cochran-Mantel-Haenszel
Comments Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or > median).
8.Secondary Outcome
Title Percentage of Participants With Complete Early Virologic Response (cEVR)
Hide Description Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Complete EVR was defined as HCV RNA < the lower limit of quantification (< 25 IU/mL) at Week 12. Data are reported as the percentage of participants with cEVR.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analysis.
Arm/Group Title ABT-267 (5 mg) Once Daily + pegIFN/RBV ABT-267 (50 mg) Once Daily + pegIFN/RBV ABT-267 (200 mg) Once Daily + pegIFN/RBV Placebo + pegIFN/RBV
Hide Arm/Group Description:
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Overall Number of Participants Analyzed 9 9 10 9
Measure Type: Number
Unit of Measure: percentage of participants
100.0 88.9 80.0 66.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABT-267 (5 mg) Once Daily + pegIFN/RBV, Placebo + pegIFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.083
Comments No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.
Method Cochran-Mantel-Haenszel
Comments Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or > median).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABT-267 (50 mg) Once Daily + pegIFN/RBV, Placebo + pegIFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.515
Comments No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.
Method Cochran-Mantel-Haenszel
Comments Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or > median).
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ABT-267 (200 mg) Once Daily + pegIFN/RBV, Placebo + pegIFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.221
Comments No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.
Method Cochran-Mantel-Haenszel
Comments Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or > median).
9.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing
Hide Description Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Sustained virologic response was defined as HCV RNA levels < the lower limit of quantification (< 25 IU/mL) 12 weeks after the last dose of pegIFN/RBV. Data are reported as the percentage of participants with SVR12.
Time Frame 12 weeks after the last dose of pegIFN/RBV
Hide Outcome Measure Data
Hide Analysis Population Description
All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.
Arm/Group Title ABT-267 (5 mg) Once Daily + pegIFN/RBV ABT-267 (50 mg) Once Daily + pegIFN/RBV ABT-267 (200 mg) Once Daily + pegIFN/RBV Placebo + pegIFN/RBV
Hide Arm/Group Description:
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Overall Number of Participants Analyzed 9 9 10 9
Measure Type: Number
Unit of Measure: percentage of participants
66.7 66.7 60.0 33.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABT-267 (5 mg) Once Daily + pegIFN/RBV, Placebo + pegIFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.155
Comments No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.
Method Regression, Logistic
Comments Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABT-267 (50 mg) Once Daily + pegIFN/RBV, Placebo + pegIFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.214
Comments No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.
Method Regression, Logistic
Comments Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ABT-267 (200 mg) Once Daily + pegIFN/RBV, Placebo + pegIFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.231
Comments No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.
Method Regression, Logistic
Comments Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.
10.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing
Hide Description Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Sustained virologic response was defined as HCV RNA levels < the lower limit of quantification (< 25 IU/mL) 24 weeks after the last dose of pegIFN/RBV. Data are reported as the percentage of participants with SVR24.
Time Frame 24 weeks after the last dose of pegIFN/RBV
Hide Outcome Measure Data
Hide Analysis Population Description
All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.
Arm/Group Title ABT-267 (5 mg) Once Daily + pegIFN/RBV ABT-267 (50 mg) Once Daily + pegIFN/RBV ABT-267 (200 mg) Once Daily + pegIFN/RBV Placebo + pegIFN/RBV
Hide Arm/Group Description:
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Overall Number of Participants Analyzed 9 9 10 9
Measure Type: Number
Unit of Measure: percentage of participants
55.6 44.4 50.0 22.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABT-267 (5 mg) Once Daily + pegIFN/RBV, Placebo + pegIFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.127
Comments No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.
Method Regression, Logistic
Comments Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABT-267 (50 mg) Once Daily + pegIFN/RBV, Placebo + pegIFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.328
Comments No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.
Method Regression, Logistic
Comments Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ABT-267 (200 mg) Once Daily + pegIFN/RBV, Placebo + pegIFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.166
Comments No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.
Method Regression, Logistic
Comments Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.
11.Secondary Outcome
Title Median Time to Suppression of Hepatitis C Virus Ribonucleic Acid (HCV RNA)
Hide Description Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Time to suppression was defined as the time (measured in days) to HCV RNA levels < the lower limit of quantification (< 25 IU/mL). Data are reported as the median number of days.
Time Frame Approximately 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.
Arm/Group Title ABT-267 (5 mg) Once Daily + pegIFN/RBV ABT-267 (50 mg) Once Daily + pegIFN/RBV ABT-267 (200 mg) Once Daily + pegIFN/RBV Placebo + pegIFN/RBV
Hide Arm/Group Description:
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Overall Number of Participants Analyzed 9 9 10 9
Median (95% Confidence Interval)
Unit of Measure: Days
27.0
(7.0 to 43.0)
16.0
(7.0 to 42.0)
21.5
(7.0 to 29.0)
84.0 [1] 
(NA to NA)
[1]
The confidence limit for the placebo group is not calculated as the participants were either suppressed at Week 12 (end of the time frame), or never suppressed and censored at Week 12.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABT-267 (5 mg) Once Daily + pegIFN/RBV, Placebo + pegIFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.
Method Log Rank
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABT-267 (50 mg) Once Daily + pegIFN/RBV, Placebo + pegIFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.
Method Log Rank
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ABT-267 (200 mg) Once Daily + pegIFN/RBV, Placebo + pegIFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.105
Comments No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.
Method Log Rank
Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Hide Description Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Extended RVR was defined as HCV RNA levels < the lower level of quantification (< 25 IU/mL) at Weeks 4 through 12. Data are reported as the percentage of participants with eRVR.
Time Frame Week 4 through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.
Arm/Group Title ABT-267 (5 mg) Once Daily + pegIFN/RBV ABT-267 (50 mg) Once Daily + pegIFN/RBV ABT-267 (200 mg) Once Daily + pegIFN/RBV Placebo + pegIFN/RBV
Hide Arm/Group Description:
Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
Overall Number of Participants Analyzed 9 9 10 9
Measure Type: Number
Unit of Measure: percentage of participants
77.8 77.8 80.0 22.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABT-267 (5 mg) Once Daily + pegIFN/RBV, Placebo + pegIFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.
Method Regression, Logistic
Comments Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABT-267 (50 mg) Once Daily + pegIFN/RBV, Placebo + pegIFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.051
Comments No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.
Method Regression, Logistic
Comments Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ABT-267 (200 mg) Once Daily + pegIFN/RBV, Placebo + pegIFN/RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.
Method Regression, Logistic
Comments Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.
Time Frame Non-serious adverse events were collected from the time of study drug administration to 30 days after last dose of study drug (ABT-267 or placebo; 16 Weeks).
Adverse Event Reporting Description A treatment-emergent adverse event was defined as any event with an onset date that was after the first dose of ABT-267/placebo and no more than 30 days after the last dose of ABT-267 or placebo.
 
Arm/Group Title ABT-267 (5 mg) Once Daily + pegIFN/RBV ABT-267 (50 mg) Once Daily + pegIFN/RBV ABT-267 (200 mg) Once Daily + pegIFN/RBV Placebo + pegIFN/RBV
Hide Arm/Group Description Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. Participants were given 10 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day. Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
All-Cause Mortality
ABT-267 (5 mg) Once Daily + pegIFN/RBV ABT-267 (50 mg) Once Daily + pegIFN/RBV ABT-267 (200 mg) Once Daily + pegIFN/RBV Placebo + pegIFN/RBV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ABT-267 (5 mg) Once Daily + pegIFN/RBV ABT-267 (50 mg) Once Daily + pegIFN/RBV ABT-267 (200 mg) Once Daily + pegIFN/RBV Placebo + pegIFN/RBV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/9 (0.00%)   0/10 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ABT-267 (5 mg) Once Daily + pegIFN/RBV ABT-267 (50 mg) Once Daily + pegIFN/RBV ABT-267 (200 mg) Once Daily + pegIFN/RBV Placebo + pegIFN/RBV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/9 (100.00%)   9/9 (100.00%)   8/10 (80.00%)   9/9 (100.00%) 
Blood and lymphatic system disorders         
ANAEMIA  1  2/9 (22.22%)  2/9 (22.22%)  2/10 (20.00%)  0/9 (0.00%) 
LEUKOPENIA  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
NEUTROPENIA  1  2/9 (22.22%)  1/9 (11.11%)  2/10 (20.00%)  1/9 (11.11%) 
THROMBOCYTOPENIA  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
Cardiac disorders         
PALPITATIONS  1  0/9 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%) 
Ear and labyrinth disorders         
EAR DISCOMFORT  1  1/9 (11.11%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%) 
VERTIGO  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
Eye disorders         
BLEPHARITIS  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
EYE INFLAMMATION  1  0/9 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%) 
VISION BLURRED  1  0/9 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%) 
VISUAL IMPAIRMENT  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
Gastrointestinal disorders         
ABDOMINAL DISTENSION  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
ABDOMINAL PAIN  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
ABDOMINAL PAIN LOWER  1  0/9 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%) 
ABDOMINAL PAIN UPPER  1  1/9 (11.11%)  0/9 (0.00%)  1/10 (10.00%)  1/9 (11.11%) 
ABDOMINAL TENDERNESS  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
DIARRHOEA  1  2/9 (22.22%)  1/9 (11.11%)  1/10 (10.00%)  1/9 (11.11%) 
DRY MOUTH  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
FLATULENCE  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
GLOSSITIS  1  0/9 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%) 
NAUSEA  1  2/9 (22.22%)  3/9 (33.33%)  4/10 (40.00%)  3/9 (33.33%) 
STOMATITIS  1  0/9 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%) 
TONGUE DISORDER  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
TOOTHACHE  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  1/9 (11.11%) 
VOMITING  1  2/9 (22.22%)  2/9 (22.22%)  3/10 (30.00%)  2/9 (22.22%) 
General disorders         
CHILLS  1  3/9 (33.33%)  2/9 (22.22%)  1/10 (10.00%)  0/9 (0.00%) 
FATIGUE  1  7/9 (77.78%)  6/9 (66.67%)  5/10 (50.00%)  6/9 (66.67%) 
FEELING ABNORMAL  1  0/9 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%) 
GAIT DISTURBANCE  1  0/9 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%) 
INFLUENZA LIKE ILLNESS  1  0/9 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  2/9 (22.22%) 
INJECTION SITE ERYTHEMA  1  1/9 (11.11%)  0/9 (0.00%)  2/10 (20.00%)  1/9 (11.11%) 
IRRITABILITY  1  1/9 (11.11%)  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%) 
NODULE  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
PAIN  1  3/9 (33.33%)  1/9 (11.11%)  3/10 (30.00%)  0/9 (0.00%) 
PYREXIA  1  1/9 (11.11%)  1/9 (11.11%)  1/10 (10.00%)  0/9 (0.00%) 
Infections and infestations         
ABSCESS LIMB  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
BRONCHITIS  1  1/9 (11.11%)  1/9 (11.11%)  0/10 (0.00%)  1/9 (11.11%) 
ORAL FUNGAL INFECTION  1  0/9 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%) 
SINUSITIS  1  1/9 (11.11%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%) 
STAPHYLOCOCCAL INFECTION  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
TOOTH ABSCESS  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
URINARY TRACT INFECTION  1  1/9 (11.11%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%) 
Injury, poisoning and procedural complications         
ARTHROPOD BITE  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
LACERATION  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
LIGAMENT SPRAIN  1  0/9 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%) 
ROAD TRAFFIC ACCIDENT  1  1/9 (11.11%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%) 
TOXICITY TO VARIOUS AGENTS  1  0/9 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%) 
Investigations         
BLOOD GLUCOSE INCREASED  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
WEIGHT DECREASED  1  0/9 (0.00%)  1/9 (11.11%)  1/10 (10.00%)  0/9 (0.00%) 
Metabolism and nutrition disorders         
DECREASED APPETITE  1  2/9 (22.22%)  2/9 (22.22%)  1/10 (10.00%)  1/9 (11.11%) 
DEHYDRATION  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
VITAMIN D DEFICIENCY  1  0/9 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%) 
Musculoskeletal and connective tissue disorders         
ARTHRALGIA  1  1/9 (11.11%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
BACK PAIN  1  0/9 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%) 
MUSCLE SPASMS  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  1/9 (11.11%) 
MYALGIA  1  1/9 (11.11%)  0/9 (0.00%)  1/10 (10.00%)  1/9 (11.11%) 
PAIN IN EXTREMITY  1  0/9 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%) 
Nervous system disorders         
DISTURBANCE IN ATTENTION  1  0/9 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%) 
DIZZINESS  1  1/9 (11.11%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%) 
HEADACHE  1  3/9 (33.33%)  3/9 (33.33%)  3/10 (30.00%)  2/9 (22.22%) 
HYPERAESTHESIA  1  0/9 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%) 
MEMORY IMPAIRMENT  1  0/9 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%) 
MIGRAINE  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
PSYCHOMOTOR HYPERACTIVITY  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
TREMOR  1  0/9 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%) 
Psychiatric disorders         
ANXIETY  1  0/9 (0.00%)  2/9 (22.22%)  2/10 (20.00%)  2/9 (22.22%) 
CONFUSIONAL STATE  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  1/9 (11.11%) 
DEPRESSION  1  1/9 (11.11%)  1/9 (11.11%)  2/10 (20.00%)  1/9 (11.11%) 
INSOMNIA  1  2/9 (22.22%)  1/9 (11.11%)  1/10 (10.00%)  2/9 (22.22%) 
MOOD ALTERED  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
MOOD SWINGS  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
NIGHTMARE  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
RESTLESSNESS  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
Reproductive system and breast disorders         
ERECTILE DYSFUNCTION  1  1/9 (11.11%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%) 
POSTMENOPAUSAL HAEMORRHAGE  1  1/9 (11.11%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
COUGH  1  0/9 (0.00%)  2/9 (22.22%)  1/10 (10.00%)  1/9 (11.11%) 
DYSPNOEA  1  1/9 (11.11%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%) 
EPISTAXIS  1  0/9 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%) 
OROPHARYNGEAL PAIN  1  0/9 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%) 
RHINORRHOEA  1  0/9 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%) 
Skin and subcutaneous tissue disorders         
DERMATITIS  1  0/9 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%) 
DRY SKIN  1  3/9 (33.33%)  1/9 (11.11%)  1/10 (10.00%)  1/9 (11.11%) 
ERYTHEMA  1  1/9 (11.11%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%) 
HEAT RASH  1  0/9 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
PRURITUS  1  0/9 (0.00%)  2/9 (22.22%)  1/10 (10.00%)  0/9 (0.00%) 
PRURITUS GENERALISED  1  1/9 (11.11%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%) 
RASH  1  3/9 (33.33%)  0/9 (0.00%)  3/10 (30.00%)  2/9 (22.22%) 
RASH ERYTHEMATOUS  1  0/9 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%) 
RASH GENERALISED  1  1/9 (11.11%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%) 
URTICARIA  1  1/9 (11.11%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%) 
Vascular disorders         
HOT FLUSH  1  1/9 (11.11%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
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Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01314261     History of Changes
Other Study ID Numbers: M12-114
First Submitted: March 11, 2011
First Posted: March 14, 2011
Results First Submitted: December 29, 2014
Results First Posted: January 26, 2015
Last Update Posted: July 2, 2018