Clinical trial NCT01629732: Phase 2b Study of BMS-986094 and Daclatasvir, With or Without Ribavirin for the Treatment of Patients With Chronic Hepatitis C
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hepatitis C Virus
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-06-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Evidence of decompensated liver disease
* Evidence of medical condition contributing to chronic liver disease other than HCV

Primary outcomes:
measure: 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)
timeFrame: Follow up Week 4
Secondary outcomes:
measure: 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)
timeFrame: Follow up Week 4 (SVR4)
measure: 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)
timeFrame: Follow up Week 4 (SVR4)
measure: 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
timeFrame: Post-treatment Week 2 (SVR2), Week 8 (SVR8), Week 12 (SVR12), Week 24 (SVR24), and Week 36 (SVR36, for the 12 week arms)
measure: Proportion of treated subjects in each study population, by regimen, who achieve HCV RNA < LOQ (detectable/undetectable)
timeFrame: Weeks 1, 2, 4, 6, 8, 12 and End of Treatment (Week 12 or 24)
measure: Proportion of subjects in each study population, be regimen, who achieve HCV RNA undetectable
timeFrame: Weeks 1, 2, 4, 6, 8, 12 and End of Treatment (Week 12 or 24)
measure: Safety and tolerability of BMS-986094 and DCV ± RBV as measured by the frequency of deaths, serious adverse events (SAEs), discontinuations due to Adverse Events (AEs), and severity Grade 3/4 laboratory abnormalities
timeFrame: Up to post treatment Week 36
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Local Institution
state: Florida
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: