Phase 2b Study of BMS-986094 and Daclatasvir, With or Without Ribavirin for the Treatment of Patients With Chronic Hepatitis C
Phase 2b Evaluation of PegIFNα Free Combinations of BMS-986094 (INX-08189) and Daclatasvir, With or Without Ribavirin, in Treatment Naive and Treatment Experienced Patients With Chronic Hepatitis C
2 other identifiers
interventional
N/A
1 country
1
Brief Summary
The purpose of this study is to evaluate the effectiveness of BMS-986094 and Daclatasvir (DCV) when given in combination with or without Ribavirin
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2013
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2012
CompletedFirst Posted
Study publicly available on registry
June 28, 2012
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMay 9, 2014
May 1, 2014
11 months
June 26, 2012
May 8, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of subjects with SVR4 defined as HCV RNA < LOQ (25 IU/mL; detectable or undetectable) at 4 weeks post treatment to be evaluated in GT1 (naive and NR) subjects randomized to the 12-week treatment arm (arms 1a, 2a, 3a, 4a)
* SVR = Sustained virologic response * HCV = Hepatitis C virus * RNA = Ribonucleic acid * LOQ = Limit of quantitation
Follow up Week 4
Secondary Outcomes (6)
Proportion of treated subjects with SVR4 in genotype (GT) 1 naive and non-responder (NR) subjects randomized to the 24-week treatment arms (arms 1b, 2b, 3b, 4b)
Follow up Week 4 (SVR4)
Proportion of treated subjects with SVR4 in genotype 1 protease inhibitor (PI)failures, genotype 4 naive, and genotype 2/3 NR/relapse subjects (arms 5, 6, 7)
Follow up Week 4 (SVR4)
Proportion of treated subjects in each study population (GT1 naive, GT1 NR, or GT1 PI-failure, GT4 naive, GT2/3 NR/relapse), for each regimen and duration, who achieve HCV RNA < LOQ at post-treatment
Post-treatment Week 2 (SVR2), Week 8 (SVR8), Week 12 (SVR12), Week 24 (SVR24), and Week 36 (SVR36, for the 12 week arms)
Proportion of treated subjects in each study population, by regimen, who achieve HCV RNA < LOQ (detectable/undetectable)
Weeks 1, 2, 4, 6, 8, 12 and End of Treatment (Week 12 or 24)
Proportion of subjects in each study population, be regimen, who achieve HCV RNA undetectable
Weeks 1, 2, 4, 6, 8, 12 and End of Treatment (Week 12 or 24)
- +1 more secondary outcomes
Study Arms (7)
Arm 1: Daclasasvir + BMS-986094 (100 mg) + Placebo
EXPERIMENTALSubjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy) Re-Randomized Arm 1 to Arm 1a and 1b (additional 12 weeks treatment)
Arm 2: Daclasasvir + BMS-986094 (200 mg)
EXPERIMENTALSubjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy) Re-Randomized Arm 2 to Arm 2a and 2b (additional 12 weeks treatment)
Arm 3: Daclasasvir + BMS-986094 (100 mg) + Placebo + Ribavirin
EXPERIMENTALSubjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy) Re-Randomized Arm 3 to Arm 3a and 3b (additional 12 weeks treatment)
Arm 4: Daclasasvir + BMS-986094 (200 mg) + Ribavirin
EXPERIMENTALSubjects will be re-randomized at Week 12 to complete therapy at this visit and enter post-treatment follow-up, or continue therapy for an additional 12 weeks (24 weeks of therapy) Re-Randomized Arm 4 to Arm 4a and 4b (additional 12 weeks treatment)
Arm 5: Daclasasvir + BMS-986094 (200 mg)
EXPERIMENTALGenotype 1 PI-failure subjects
Arm 6: Daclasasvir + BMS-986094 (200 mg)
EXPERIMENTALGenotype 4 naive subjects
Arm 7: Daclasasvir + BMS-986094 (200 mg)
EXPERIMENTALGenotype 2/3 NR/relapse Subjects
Interventions
Film coated tablet, Oral, 60 mg, Once daily, 12 or 24 weeks
Capsule, Oral, 100 mg, Once daily, 12 or 24 weeks
Film coated tablet, Oral, 1000 mg or 1200 mg based on weight, Twice daily, 12 or 24 weeks
Capsule, Oral, 0 mg, Once daily, 12 or 24 weeks
Eligibility Criteria
You may qualify if:
- Males and females, ≥ 18 years of age
- Subjects chronically infected with Hepatitis C virus (HCV) genotype 1,2,3 or 4
- HCV RNA viral load ≥ 10,000 IU/mL
- Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)
- Body Mass Index (BMI) of 18 to 35 kg/m2
- Seronegative for Hepatitis C virus (HIV) and Hepatitis B
You may not qualify if:
- Evidence of decompensated liver disease
- Evidence of medical condition contributing to chronic liver disease other than HCV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution
Orlando, Florida, 32804, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2012
First Posted
June 28, 2012
Study Start
March 1, 2013
Primary Completion
February 1, 2014
Study Completion
June 1, 2014
Last Updated
May 9, 2014
Record last verified: 2014-05