Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV
- Registration Number
- NCT02032901
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
To study the combination of Daclatasvir and Sofosbuvir for the treatment of hepatitis C virus (HCV) Genotype 3 infection
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 173
- 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
Key
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A1:Daclatasvir + Sofosbuvir in treatment-naive subjects Sofosbuvir Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks A1:Daclatasvir + Sofosbuvir in treatment-naive subjects Daclatasvir Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks A2:Daclatasvir + Sofosbuvir in treatment-experienced subjects Sofosbuvir Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks A2:Daclatasvir + Sofosbuvir in treatment-experienced subjects Daclatasvir Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
- Primary Outcome Measures
Name Time Method Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND) 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) 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 Outcome Measures
Name Time Method 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) Participants categorized into 2 genotypes (CC and non-CC) based on SNPs in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus (HCV) RNA levels below lower limit of quantitation (LLOQ) below target detected or target not detected at follow-up Week 12 (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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 who achieved HCV RNA \<LLOQ,TD or TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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) 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. Cirrhosis was considered a negative predictor of SVR in participants treated with an interferon formulation or ribavirin. Presence or absence of cirrhosis was determined at baseline and follow-up Week 12 in the participants to evaluate the post-treatment relapse.
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 AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND) Week 4 RVR was defined as hepatitis C virus RNA levels to be \< lower limit of quantitation ie, 25 IU/mL TND at Week 4. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND) Week 12 cEVR was defined as hepatitis C virus RNA levels to be \< lower limit of quantitation ie, 25 IU/mL TND at Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND) Up to the end of treatment (up to 24 weeks) EOTR were defined as hepatitis C virus RNA levels to be \< lower limit of quantitation ie, 25 IU/mL TND at end of treatment. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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) Percentage of participants who achieved HCV RNA \<LLOQ, TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Trial Locations
- Locations (31)
Scripps Clinic
🇺🇸La Jolla, California, United States
University of Florida Hepatology Research
🇺🇸Gainesville, Florida, United States
Midland Florida Clinical Research Center, LLC
🇺🇸Deland, Florida, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
Premier Medical Group Of The Hudson Valley, Pc
🇺🇸Poughkeepsie, New York, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Fundacion De Investigacion De Diego
🇵🇷San Juan, Puerto Rico
Southwest Care Center
🇺🇸Santa Fe, New Mexico, United States
Dupage Medical Group
🇺🇸Downers Grove, Illinois, United States
Huntington Medical Research Institutes
🇺🇸Pasadena, California, United States
Clinical Research Centers Of America
🇺🇸Murray, Utah, United States
Main Line Gastroenterology Associates Pc
🇺🇸Perkasie, Pennsylvania, United States
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
Gastrointestinal Specialists Of Georgia
🇺🇸Marietta, Georgia, United States
Mercy Medical Center, Inc.
🇺🇸Baltimore, Maryland, United States
Anthony M. Mills MD Inc
🇺🇸Los Angeles, California, United States
Precision Research Institute, LLC
🇺🇸San Diego, California, United States
Peter J Ruane MD Inc
🇺🇸Los Angeles, California, United States
Medical Associates Research Group
🇺🇸San Diego, California, United States
National Research Institute
🇺🇸Los Angeles, California, United States
Quest Clinical Research
🇺🇸San Francisco, California, United States
Kansas City Research Institute
🇺🇸Kansas City, Missouri, United States
American Research Corporation
🇺🇸San Antonio, Texas, United States
Digestive Disease Associates, P.A.
🇺🇸Baltimore, Maryland, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Asheville Gastroenterology Associates, PA
🇺🇸Asheville, North Carolina, United States
Digestive Health Specialists, PA
🇺🇸Winston-salem, North Carolina, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Center For Liver Diseases
🇺🇸Pittsburgh, Pennsylvania, United States
Texas Clinical Research Institute, LLC
🇺🇸Arlington, Texas, United States
Lifetree Clinical Research
🇺🇸Salt Lake City, Utah, United States