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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01629732

Enrollment

Registered

2012-06-28

Start date

2013-03-31

Completion date

2014-06-30

Last updated

2014-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C Virus

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

Interventions

DRUGDaclatasvir

Film coated tablet, Oral, 60 mg, Once daily, 12 or 24 weeks

DRUGBMS-986094

Capsule, Oral, 100 mg, Once daily, 12 or 24 weeks

DRUGRibavirin

Film coated tablet, Oral, 1000 mg or 1200 mg based on weight, Twice daily, 12 or 24 weeks

DRUGPlacebo for BMS-986094

Capsule, Oral, 0 mg, Once daily, 12 or 24 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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)	Follow up Week 4	* SVR = Sustained virologic response * HCV = Hepatitis C virus * RNA = Ribonucleic acid * LOQ = Limit of quantitation

Secondary

Measure	Time frame
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 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 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)
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	Up to post treatment Week 36
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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026