A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Non-cirrhotic Subjects With Genotype 1 Chronic Hepatitis C

Bristol-Myers Squibb44 sites in 3 countries416 target enrollmentDecember 2013

ConditionsHepatitis C

InterventionsDCV/ASV/BMS-791325

DrugsDCV/ASV/BMS-791325

Overview

Phase: Phase 3
Intervention: DCV/ASV/BMS-791325
Conditions: Hepatitis C
Sponsor: Bristol-Myers Squibb
Enrollment: 416
Locations: 44
Primary Endpoint: Proportion of treated subjects in the naive cohort with sustained virologic response (SVR) 12
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects

Registry

clinicaltrials.gov

Start Date

December 2013

End Date

November 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects chronically infected with HCV genotype 1
•HCV RNA ≥ 10,000 IU/mL at screening
•Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), RBV, or HCV DAA (protease, polymerase inhibitor, etc.)
•Treatment-experienced subjects are eligible

Exclusion Criteria

•Evidence of cirrhosis
•Liver or any other organ transplant
•Current or known history of cancer within 5 years prior to enrollment
•Documented or suspected HCC
•Evidence of decompensated liver

Arms & Interventions

A 1: DCV/ASV/BMS-791325 in treatment-naive subjects

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks

Intervention: DCV/ASV/BMS-791325

A 2: DCV/ASV/BMS-791325 in treatment-experienced subjects

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks

Intervention: DCV/ASV/BMS-791325

Outcomes

Primary Outcomes

Proportion of treated subjects in the naive cohort with sustained virologic response (SVR) 12

Time Frame: Post-Treatment Week 12

SVR12 is defined as HCV ribonucleic acid (RNA) \< limit of quantitation (LOQ) target detected or target not detected (LOQ TD/TND) at post treatment Week 12

Secondary Outcomes

Proportion of subjects in the experienced cohort with SVR12(Follow up Week 12)
Proportion of subjects in each cohort who achieve HCV RNA <LOQ TD/TND(On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24))
Proportion of subjects in each cohort who achieve HCV RNA <LOQ TND(On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment weeks 4, 8, 12 and 24)
Safety measured by frequency of serious AEs (SAEs) and discontinuations due to adverse events (AEs) through the end of treatment in each cohort(Up to post treatment week 4 (±7 days))
Proportion of anemia defined as Hg <10 g/dL on-treatment and Hg ≥10 g/dL at baseline , in each cohort(Up to post treatment week 4 (±7 days))
Rates of selected grade 3-4 lab abnormalities (hematologic and liver function) in each cohort(Up to post treatment week 4 (±7 days))
Proportion of subjects in each cohort achieving SVR12 associated with HCV geno subtype 1a vs 1b(Post treatment week 12)
Proportion of subjects in each cohort achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism (SNP) status (CC genotype or non-CC genotype)(Post treatment week 12)
Proportion of subjects in each cohort achieving SVR12 associated with stage of liver fibrosis(Post treatment week 12)