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A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus Infection (CERTAIN-2)

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: NCT02723084
Recruitment Status : Completed
First Posted : March 30, 2016
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Hepatitis C Virus
Hepatitis C Virus
Interventions Drug: ABT-493/ABT-530
Drug: sofosbuvir (SOF)
Drug: ribavirin (RBV)
Enrollment 136
Recruitment Details  
Pre-assignment Details Intent-to-treat population: all participants who received at least 1 dose of study drug.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description Co-formulated ABT-493/ABT-530 (300 mg/120 mg) administered once daily (QD) for 8 weeks in HCV genotype (GT) 2 -infected, DAA treatment-naïve participants without cirrhosis. sofosbuvir (400 mg) QD co-administered with weight based ribavirin (RBV) 600-1000 mg divided twice daily (BID) for 12 weeks in HCV GT2 -infected, DAA treatment-naïve participants without cirrhosis.
Period Title: Overall Study
Started 90 46
Completed 86 45
Not Completed 4 1
Reason Not Completed
Withdrawal by Subject             1             1
Lost to Follow-up             3             0
Arm/Group Title Arm A Arm B Total
Hide Arm/Group Description Co-formulated ABT-493/ABT-530 (300 mg/120 mg) administered once daily (QD) for 8 weeks in HCV genotype (GT) 2 -infected, DAA treatment-naïve participants without cirrhosis. sofosbuvir (400 mg) QD co-administered with weight based ribavirin (RBV) 600-1000 mg divided twice daily (BID) for 12 weeks in HCV GT2 -infected, DAA treatment-naïve participants without cirrhosis. Total of all reporting groups
Overall Number of Baseline Participants 90 46 136
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of study drug (ITT population).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 90 participants 46 participants 136 participants
57.46  (13.07) 58.89  (13.64) 57.94  (13.23)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 46 participants 136 participants
Female
48
  53.3%
25
  54.3%
73
  53.7%
Male
42
  46.7%
21
  45.7%
63
  46.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 46 participants 136 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
90
 100.0%
46
 100.0%
136
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Non-inferiority of Arm A to Arm B
Hide Description SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. The primary efficacy endpoint was non-inferiority of the ABT-493/ABT-530 8-week regimen (Arm A) to the sofosbuvir and ribavirin 12 week regimen (Arm B) in SVR12 using a non-inferiority margin of 10% in the intent-to-treat (ITT) population.
Time Frame 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
Co-formulated ABT-493/ABT-530 (300 mg/120 mg) administered once daily (QD) for 8 weeks in HCV genotype (GT) 2 -infected, DAA treatment-naïve participants without cirrhosis.
sofosbuvir (400 mg) QD co-administered with weight based ribavirin (RBV) 600-1000 mg divided twice daily (BID) for 12 weeks in HCV GT2 -infected, DAA treatment-naïve participants without cirrhosis.
Overall Number of Participants Analyzed 90 46
Measure Type: Number
Unit of Measure: percentage of participants
97.8 93.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A, Arm B
Comments Difference in SVR12 rates (Arm A - Arm B)
Type of Statistical Test Non-Inferiority
Comments The percentage of participants achieving SVR12 was calculated for each arm and a 2- sided 95% confidence interval (CI) for the difference in SVR12 rates (Arm A minus Arm B) was calculated using the normal approximation to the binomial distribution to assess non-inferiority in SVR12 rates of arm A to arm B. If the lower bound of the CI for the difference was above the noninferiority margin of –10%, then arm A was considered non-inferior to arm B.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 4.3
Confidence Interval (2-Sided) 95%
-3.5 to 12.1
Estimation Comments 95% CI was calculated using the normal approximation to the binomial distribution.
2.Secondary Outcome
Title Percentage of Participants in Arm A With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Hide Description SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.
Time Frame 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.
Arm/Group Title Arm A
Hide Arm/Group Description:
Co-formulated ABT-493/ABT-530 (300 mg/120 mg) administered once daily (QD) for 8 weeks in HCV genotype (GT) 2 -infected, DAA treatment-naïve participants without cirrhosis.
Overall Number of Participants Analyzed 90
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
97.8
(94.7 to 100.0)
3.Secondary Outcome
Title Percentage of Participants With With On-treatment Virologic Failure
Hide Description On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. 95% CI was calculated using the Wilson score method.
Time Frame Treatment Weeks 1, 2, 4, 8 (end of treatment for arm A), and 12 (end of treatment for arm B) or premature discontinuation from treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug (ITT population).
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
Co-formulated ABT-493/ABT-530 (300 mg/120 mg) administered once daily (QD) for 8 weeks in HCV genotype (GT) 2 -infected, DAA treatment-naïve participants without cirrhosis.
sofosbuvir (400 mg) QD co-administered with weight based ribavirin (RBV) 600-1000 mg divided twice daily (BID) for 12 weeks in HCV GT2 -infected, DAA treatment-naïve participants without cirrhosis.
Overall Number of Participants Analyzed 90 46
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 4.1)
0
(0.0 to 7.7)
4.Secondary Outcome
Title Percentage of Participants With Post-Treatment Relapse
Hide Description Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding participants who were been shown to be re-infected. 95% CI was calculated using the Wilson score method.
Time Frame From the end of treatment through 12 weeks after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study drug (ITT population).
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
Co-formulated ABT-493/ABT-530 (300 mg/120 mg) administered once daily (QD) for 8 weeks in HCV genotype (GT) 2 -infected, DAA treatment-naïve participants without cirrhosis.
sofosbuvir (400 mg) QD co-administered with weight based ribavirin (RBV) 600-1000 mg divided twice daily (BID) for 12 weeks in HCV GT2 -infected, DAA treatment-naïve participants without cirrhosis.
Overall Number of Participants Analyzed 89 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 4.1)
4.4
(1.2 to 14.8)
Time Frame Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). Serious adverse events (SAEs) were collected starting from the time that the informed consent was signed until the end of the study (up to 21 weeks).
Adverse Event Reporting Description TEAEs and Treatment-emergent serious adverse events (TESAEs) are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
 
Arm/Group Title ARM A ARM B
Hide Arm/Group Description Co-formulated ABT-493/ABT-530 (300 mg/120 mg) administered once daily (QD) for 8 weeks in HCV genotype (GT) 2 -infected, DAA treatment-naïve participants without cirrhosis. sofosbuvir (400 mg) QD co-administered with weight based ribavirin (RBV) 600-1000 mg divided twice daily (BID) for 12 weeks in HCV GT2 -infected, DAA treatment-naïve participants without cirrhosis.
All-Cause Mortality
ARM A ARM B
Affected / at Risk (%) Affected / at Risk (%)
Total   0/90 (0.00%)   0/46 (0.00%) 
Hide Serious Adverse Events
ARM A ARM B
Affected / at Risk (%) Affected / at Risk (%)
Total   2/90 (2.22%)   2/46 (4.35%) 
Cardiac disorders     
ANGINA UNSTABLE  1  1/90 (1.11%)  0/46 (0.00%) 
Infections and infestations     
PNEUMONIA  1  0/90 (0.00%)  1/46 (2.17%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
CASTLEMAN'S DISEASE  1  0/90 (0.00%)  1/46 (2.17%) 
Respiratory, thoracic and mediastinal disorders     
PNEUMOTHORAX SPONTANEOUS  1  1/90 (1.11%)  0/46 (0.00%) 
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ARM A ARM B
Affected / at Risk (%) Affected / at Risk (%)
Total   20/90 (22.22%)   26/46 (56.52%) 
Blood and lymphatic system disorders     
ANAEMIA  1  0/90 (0.00%)  16/46 (34.78%) 
Gastrointestinal disorders     
NAUSEA  1  3/90 (3.33%)  3/46 (6.52%) 
STOMATITIS  1  1/90 (1.11%)  3/46 (6.52%) 
General disorders     
MALAISE  1  5/90 (5.56%)  4/46 (8.70%) 
Infections and infestations     
NASOPHARYNGITIS  1  9/90 (10.00%)  5/46 (10.87%) 
Investigations     
BLOOD BILIRUBIN INCREASED  1  1/90 (1.11%)  7/46 (15.22%) 
Metabolism and nutrition disorders     
HYPERURICAEMIA  1  0/90 (0.00%)  3/46 (6.52%) 
Nervous system disorders     
HEADACHE  1  6/90 (6.67%)  1/46 (2.17%) 
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
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
Phone: 800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02723084    
Other Study ID Numbers: M15-828
First Submitted: March 24, 2016
First Posted: March 30, 2016
Results First Submitted: January 3, 2018
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019