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Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01563536
Recruitment Status : Completed
First Posted : March 27, 2012
Results First Posted : January 8, 2015
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hepatitis C Infection
Interventions Drug: ABT-267
Drug: ABT-450
Drug: ABT-333
Drug: Ritonavir
Drug: Ribavirin
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV
Hide Arm/Group Description ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
Period Title: Overall Study
Started 6 6
Completed 5 4
Not Completed 1 2
Reason Not Completed
Withdrawal by Subject             0             2
Lost to Follow-up             1             0
Arm/Group Title ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV Total
Hide Arm/Group Description ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
51.5  (4.76) 46.8  (11.84) 49.2  (8.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
4
  66.7%
3
  50.0%
7
  58.3%
Male
2
  33.3%
3
  50.0%
5
  41.7%
1.Primary Outcome
Title Maximum Plasma Concentration (Cmax) of ABT-267 Following Monotherapy on Day 1
Hide Description Blood samples were collected pre-dose (time 0) and at 2, 4, and 6 hours post-dose on Day 1 and pre-dose on Day 2 (ABT-267 monotherapy). The samples were analyzed for ABT-267 using validated analytical methods. Maximum plasma concentration (Cmax; measured in ng/mL) was estimated using noncompartmental analyses.
Time Frame Day 1 (pre-dose [time 0] and at 2, 4, and 6 hours post-dose) and Day 2 (pre-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (intent-to-treat [ITT] population).
Arm/Group Title ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV
Hide Arm/Group Description:
ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
1.66  (0.21) 41.0  (16.5)
2.Primary Outcome
Title Time of Maximum Plasma Concentration (Tmax) of ABT-267 Following Monotherapy on Day 1
Hide Description Blood samples were collected pre-dose (time 0) and at 2, 4, and 6 hours post-dose on Day 1 and pre-dose on Day 2 (ABT-267 monotherapy). The samples were analyzed for ABT-267 using validated analytical methods. Time of maximum plasma concentration (Tmax; measured in hours) was estimated using noncompartmental analyses.
Time Frame Day 1 (pre-dose [time 0] and at 2, 4, and 6 hours post-dose) and Day 2 (pre-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (ITT population).
Arm/Group Title ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV
Hide Arm/Group Description:
ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: hours
3.67  (0.82) 3.67  (1.5)
3.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[24]) of ABT-267 Following Monotherapy on Day 1
Hide Description Blood samples were collected pre-dose (time 0) and at 2, 4, and 6 hours post-dose on Day 1 and pre-dose on Day 2 (ABT-267 monotherapy). The samples were analyzed for ABT-267 using validated analytical methods. Area under the plasma concentration-time curve from time 0 to 24 hours (AUC[24]; measured in ng multiplied by hour/mL) was estimated using noncompartmental analyses.
Time Frame Day 1 (pre-dose [time 0] and at 2, 4, and 6 hours post-dose) and Day 2 (pre-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (ITT population).
Arm/Group Title ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV
Hide Arm/Group Description:
ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
18.0  (2.46) 467  (236)
4.Primary Outcome
Title Plasma Concentration of ABT-267 Pre-dose (Ctrough) on Day 2 and Day 3
Hide Description Blood samples were collected pre-dose on Day 2 (prior to second dose of ABT-267 monotherapy) and pre-dose on Day 3 (prior to first dose of combination therapy). The samples were analyzed for ABT-267 using validated analytical methods. Pre-dose plasma concentrations on Day 2 and Day 3 (Ctrough, measured in ng/mL) are reported.
Time Frame Day 2 (pre-dose) and Day 3 (pre-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (ITT population).
Arm/Group Title ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV
Hide Arm/Group Description:
ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
Day 2 Ctrough 0  (0) 5.2  (1.78)
Day 3 Ctrough 0.228  (0.263) 6.62  (3.77)
5.Primary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description

An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.

The investigator assessed the relationship of each AE to the use of direct-acting antiviral agents (DAAs), and rated the severity of each event as either: Mild: The AE was transient and easily tolerated by the participant; Moderate: The AE caused the participant discomfort and interrupted usual activities; Severe: The AE caused considerable interference with the participant's usual activities and could have been incapacitating or life-threatening.

A serious adverse event was any event that resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in a congenital anomaly or persistent or significant disability or was any other important medical event requiring medical or surgical intervention.

Time Frame All AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (safety population).
Arm/Group Title ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV
Hide Arm/Group Description:
ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: participants
Any AE 3 5
Any AE at least possibly related to DAAs 3 4
Any severe AE 0 1
Any serious AE 0 2
Any AE leading to discontinuation of study drug 0 1
Any AE leading to interruption of study drug 0 0
Any AE leading to RBV dose modification 0 1
Any fatal AE 0 0
Deaths 0 0
6.Primary Outcome
Title Mean Maximal Decrease From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During ABT-267 Monotherapy
Hide Description The baseline value was the last measurement before the first dose of ABT-267 monotherapy (Day 1). The maximal decrease during monotherapy was the change from baseline to the lowest log10 IU/mL HCV RNA level any time from the first dose of ABT-267 on Day 1 to the last log10 HCV RNA level before the first dose of ABT-267 combination therapy (Study Day 3).
Time Frame Pre-dose on Days 1, 2, and 3
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (ITT population).
Arm/Group Title ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV
Hide Arm/Group Description:
ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
Overall Number of Participants Analyzed 6 6
Least Squares Mean (Standard Error)
Unit of Measure: log10 IU/mL
-1.6  (0.41) -3.1  (0.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV, ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments Pre-specified 2-sided significance level of 0.05.
Method ANCOVA
Comments Analysis of covariance (ANCOVA) with the baseline log10 HCV RNA values as a covariate and with an effect for treatment arm.
Method of Estimation Estimation Parameter Mean Difference (Maximal Decrease)
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-2.81 to -0.13
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks and 24 Weeks After Combination Therapy
Hide Description The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 and 24 weeks after the last dose of combination study drug. The LLOQ for the assay was 25 IU/mL.
Time Frame 12 and 24 weeks after last dose of combination study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (ITT population); participants with missing data were counted as non-responders.
Arm/Group Title ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV
Hide Arm/Group Description:
ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: percentage of participants
12 Weeks Post-treatment 83.3 83.3
24 Weeks Post-treatment 83.3 83.3
8.Secondary Outcome
Title Percentage of Participants With Rapid Virologic Response
Hide Description The percentage of participants with virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) after 4 weeks of combination therapy.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (ITT population); participants with missing data were counted as non-responders.
Arm/Group Title ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV
Hide Arm/Group Description:
ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: percentage of participants
83.3 100
9.Secondary Outcome
Title Percentage of Participants With End-of-Treatment Response
Hide Description The percentage of participants with virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) at the end of combination therapy (12 weeks).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (ITT population); participants with missing data were counted as non-responders.
Arm/Group Title ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV
Hide Arm/Group Description:
ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: percentage of participants
83.3 83.3
10.Secondary Outcome
Title Percentage of Participants With Extended Rapid Virologic Response
Hide Description The percentage of participants with virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) at Weeks 4 through 12 of combination therapy.
Time Frame Weeks 4 to 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (ITT population); participants with missing data were counted as non-responders.
Arm/Group Title ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV
Hide Arm/Group Description:
ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: percentage of participants
83.3 83.3
11.Secondary Outcome
Title Mean Change in Viral Load From Baseline to Pre-dose on Day 2 and Day 3 of ABT-267 Monotherapy
Hide Description The relationship between ABT-267 dose, ABT-267 concentration, and response was analyzed as the change in viral load (measured as log10 IU/mL) from baseline (pre-dose on Day 1) to pre-dose on Days 2 and 3. Plasma concentrations of ABT-267 pre-dose on Days 2 and 3 are presented above in 4. Primary Outcome: Plasma Concentration of ABT-267 Pre-dose (Ctrough) on Day 2 and Day 3.
Time Frame Predose on Days 1, 2, and 3
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (ITT population).
Arm/Group Title ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV
Hide Arm/Group Description:
ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Day 2 Mean change in Viral Load from Baseline -1.95  (0.630) -2.85  (0.421)
Day 3 Mean change in Viral Load from Baseline -1.96  (0.405) -3.10  (0.257)
12.Other Pre-specified Outcome
Title Resistance-Associated Variants and Phenotypic Resistance
Hide Description Baseline (pre-dose on Day 1) samples were analyzed for resistance-associated amino acid (AA) variants using population sequencing. Phenotypic resistance to ABT-267 at Baseline was assessed by calculating the fold difference in the the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Day 3 samples were analyzed using population sequencing and were compared with the baseline and appropriate prototypic reference sequences to assess AA changes. Phenotypic resistance at Day 3 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding Baseline sample. The number of participants with variants at resistance-associated AA positions and phenotypic resistance at Baseline and Day 3 are presented.
Time Frame Day 1 Pre-dose (Baseline) and Day 3 Pre-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug (ITT population) and had evaluable data were analyzed for baseline resistance-associated amino acid variants; the development of viral resistance was analyzed in all participants who received at least 1 dose of ABT-267 whose samples had sufficient viral titer to allow analysis.
Arm/Group Title ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV
Hide Arm/Group Description:
ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: participants
Baseline Variants in NS5A (n=5, 6) 2 0
Baseline Resistance >10-fold (n=5, 6) 1 0
Day 3 Variants in NS5A (n=5, 2) 6 2
Day 3 Resistance >10-fold (n=5, 2) 1 2
Time Frame All AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (60 weeks).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV
Hide Arm/Group Description ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
All-Cause Mortality
ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   2/6 (33.33%) 
Infections and infestations     
LABYRINTHITIS  1  0/6 (0.00%)  1/6 (16.67%) 
Psychiatric disorders     
MANIA  1  0/6 (0.00%)  1/6 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV
Affected / at Risk (%) Affected / at Risk (%)
Total   3/6 (50.00%)   5/6 (83.33%) 
Cardiac disorders     
TACHYCARDIA  1  0/6 (0.00%)  1/6 (16.67%) 
Gastrointestinal disorders     
DIARRHOEA  1  1/6 (16.67%)  2/6 (33.33%) 
DRY MOUTH  1  0/6 (0.00%)  1/6 (16.67%) 
NAUSEA  1  0/6 (0.00%)  1/6 (16.67%) 
General disorders     
ASTHENIA  1  0/6 (0.00%)  1/6 (16.67%) 
CHEST PAIN  1  0/6 (0.00%)  1/6 (16.67%) 
FATIGUE  1  1/6 (16.67%)  2/6 (33.33%) 
Infections and infestations     
GASTROENTERITIS  1  0/6 (0.00%)  1/6 (16.67%) 
UPPER RESPIRATORY TRACT INFECTION  1  1/6 (16.67%)  0/6 (0.00%) 
Injury, poisoning and procedural complications     
EXCORIATION  1  0/6 (0.00%)  1/6 (16.67%) 
Investigations     
BLOOD BILIRUBIN INCREASED  1  0/6 (0.00%)  2/6 (33.33%) 
HAEMOGLOBIN DECREASED  1  0/6 (0.00%)  2/6 (33.33%) 
Metabolism and nutrition disorders     
DEHYDRATION  1  0/6 (0.00%)  1/6 (16.67%) 
HYPOKALAEMIA  1  1/6 (16.67%)  0/6 (0.00%) 
VITAMIN D DEFICIENCY  1  1/6 (16.67%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders     
INTERVERTEBRAL DISC PROTRUSION  1  1/6 (16.67%)  0/6 (0.00%) 
Nervous system disorders     
BURNING SENSATION  1  0/6 (0.00%)  1/6 (16.67%) 
DIZZINESS  1  0/6 (0.00%)  1/6 (16.67%) 
HEADACHE  1  1/6 (16.67%)  2/6 (33.33%) 
RESTLESS LEGS SYNDROME  1  1/6 (16.67%)  0/6 (0.00%) 
Psychiatric disorders     
ABNORMAL DREAMS  1  1/6 (16.67%)  1/6 (16.67%) 
SLEEP DISORDER  1  1/6 (16.67%)  0/6 (0.00%) 
Renal and urinary disorders     
DYSURIA  1  0/6 (0.00%)  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders     
DYSPNOEA  1  0/6 (0.00%)  1/6 (16.67%) 
SINUS CONGESTION  1  0/6 (0.00%)  1/6 (16.67%) 
Skin and subcutaneous tissue disorders     
DERMATITIS  1  0/6 (0.00%)  1/6 (16.67%) 
NIGHT SWEATS  1  0/6 (0.00%)  1/6 (16.67%) 
RASH  1  0/6 (0.00%)  2/6 (33.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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
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Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
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Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01563536    
Other Study ID Numbers: M13-386
First Submitted: January 27, 2012
First Posted: March 27, 2012
Results First Submitted: December 29, 2014
Results First Posted: January 8, 2015
Last Update Posted: July 2, 2018