A Phase 3 Evaluation of Daclatasvir and Sofosbuvir in Treatment Naive and Treatment Experienced Subjects With Genotype 3 Chronic Hepatitis C Infection
Overview
- Phase
- Phase 3
- Intervention
- Daclatasvir
- Conditions
- Hepatitis C
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 173
- Locations
- 31
- Primary Endpoint
- Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
To study the combination of Daclatasvir and Sofosbuvir for the treatment of hepatitis C virus (HCV) Genotype 3 infection
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
- •Subjects chronically infected with hepatitis C virus (HCV) genotype 3
- •Subjects who are HCV treatment-naive
- •Subjects who are HCV treatment-experienced (previous exposure to non-structural 5A inhibitors is prohibited)
- •HCV RNA ≥10,000 IU/mL at screening
Exclusion Criteria
- •HCV Genotypes other than genotype-3 infection; mixed genotype infections are not permitted
- •Liver or any other organ 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, 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
A1:Daclatasvir + Sofosbuvir in treatment-naive subjects
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
Intervention: Daclatasvir
A1:Daclatasvir + Sofosbuvir in treatment-naive subjects
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
Intervention: Sofosbuvir
A2:Daclatasvir + Sofosbuvir in treatment-experienced subjects
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
Intervention: Daclatasvir
A2:Daclatasvir + Sofosbuvir in treatment-experienced subjects
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
Intervention: Sofosbuvir
Outcomes
Primary Outcomes
Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)
Time Frame: Week 12 (Follow-up period)
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)
Time Frame: Week 12 (Follow-up period)
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, TD or TND at follow-up Week 12. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
Secondary Outcomes
- Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND)(Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period))
- Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)(Baseline, Week 12 (Follow-up period))
- Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms (SNPs) Who Achieved Sustained Virologic Response After 12 Weeks of Follow-up (SVR12)(Week 12 (Follow-up period))
- Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)(From Day 1 first dose to last dose plus 7 days)
- Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND)(Week 4)
- Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND)(Week 12)
- Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND)(Up to the end of treatment (up to 24 weeks))
- Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND)(Week 1, 2, 6, 8 (treatment period))