NCT02170727CompletedPhase 3
A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1
Bristol-Myers Squibb1 site in 1 country199 target enrollmentStarted: June 26, 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 199
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Sustained Virologic Response 12 (SVR12) in the Naive Cohort
Study Overview
Brief Summary
To demonstrate the effectiveness of Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed dose combination in Genotype 1 Chronic Hepatitis C subjects.
Detailed Description
US National Institutes of Health Division of AIDs (DAIDS)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject chronically infected with HCV genotype 1 (GT-1)
- •Subject without cirrhosis or with compensated cirrhosis (Child Pugh Class A)
- •HCV RNA ≥ 10,000 IU/mL at screening
- •Treatment-naïve subject with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), Ribavirin (RBV), or HCV DAA (protease, polymerase inhibitor, etc.)
- •Interferon (IFN) experienced subject who have received previous treatment with IFNα, with or without RBV
Exclusion Criteria
- •Liver or any other transplant (including hematopoietic stem cell transplants) other than cornea and hair;
- •Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening;
- •Documented or suspected hepatocellular carcinoma (HCC), as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed);
- •Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
Arms & Interventions
Arm 1 : DCV/ASV/BMS-791325
Experimental
DCV 30 mg (as the free base) / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks
Intervention: DCV/ASV/BMS-791325 (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Sustained Virologic Response 12 (SVR12) in the Naive Cohort
Time Frame: Post treatment Week 12
Percentage of Participants with SVR12 in the naive cohort, defined as HCV RNA \< LLOQ target detected (TD) or target not detected (TND) (LOQ TD/TND) at post-treatment follow-up Week 12.
Secondary Outcomes
- Percentage of Participants With SVR12 in the Interferon Alfa (IFN-a) Experienced Cohort(Post treatment Week 12)
- Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND(On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8), 24 (SVR24) and EOT (end of treatment))
- Percentage of Participants Who Achieved HCV RNA < LLOQ TND(On-treatment Weeks: 1, 2, 4, 6, 8, and 12 and post treatment weeks 4, 8, 12, 24 and EOT (end of treatment))
- Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment(Up to post treatment week 4)
- Percentage of Participants With Anemia Defined as Hb < 10 g/dL On-treatment Who Had Hb >=10 g/dL at Baseline(Up to post treatment week 4)
- Percentage of Participants Who Achieved SVR12 Associated With Hepatitis C Virus (HCV) Genotype Subtype 1a vs 1b(Post treatment week 12)
- Proportion of Participants Who Achieved SVR12 Associated With IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) Status (CC Genotype or Non CC Genotype)(Post treatment Week 12)
- Proportion of Cirrhotic and Non Cirrhotic Participants Who Achieved SVR12(Post treatment Week 12)
- Number of Participants With Selected Grade 3/4 Laboratory Abnormalities(Post treatment week 4)
- Number of Participants With/Without Cirrhosis as Measured by SAEs and Discontinuations Due to AEs(Up to post treatment week 4)
- Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities(Up to post treatment week 4)
Investigators
Study Sites (1)
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