Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care
- Conditions
- Chronic Hepatitis C
- Interventions
- Registration Number
- NCT01359644
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post treatment
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
- Men and women, ages 18 to 70 years.
- Participants infected with hepatitis C virus (HCV) genotype 1, 2, or 3, with no previous exposure to an interferon formulation (ie, interferon-alpha, pegylated interferon-alpha) ribavirin, or other HCV-specific direct-acting antiviral (including daclatasvir and PSI-7977).
- Patients should have chronic hepatitis C genotype 1a, 1b, 2, or 3 as documented by: positive test results for anti-HCV antibody; HCV RNA; or a HCV genotype at least 6 months prior to screening, and HCV RNA and anti-HCV antibody at the time of screening.
- Evidence of a medical condition associate with chronic liver disease other than HCV.
- History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis.
- History of hemophilia.
- History of torsade de pointes.
- 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 enrollment.
- History of gastrointestinal disease or surgical procedure (except cholecystectomy).
- History of clinically significant cardiac disease.
- Blood transfusion within 4 weeks prior to study drug administration.
- Poor venous access.
- Any other medical, psychiatric, and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment A: PSI-7977 + Daclatasvir PSI-7977 Genotype 1a or 1b Treatment B: PSI-7977 + Daclatasvir PSI-7977 Genotype 2 or 3 Treatment C: PSI-7977 + Daclatasvir PSI-7977 Genotype 1a or 1b Treatment D: PSI-7977 + Daclatasvir PSI-7977 Genotype 2 or 3 Treatment H: PSI-7977 + BMS-790052 + Ribavirin PSI-7977 Hepatitis C virus genotype 1, treatment-naive patients Genotype 1a or 1b Treatment E: PSI-7977 + Daclatasvir + Ribavirin PSI-7977 Genotype 1a or 1b Treatment F: PSI-7977 + Daclatasvir+ Ribavirin PSI-7977 Genotype 2 or 3 Treatment G: PSI-7977 + Daclatasvir PSI-7977 Hepatitis C virus genotype 1, treatment-naive patients Genotype 1a or 1b Treatment I: PSI-7977 + Daclatasvir PSI-7977 Patients who experienced telaprevir/boceprevir treatment failure Genotype 1a or 1b Treatment I: PSI-7977 + Daclatasvir Daclatasvir Patients who experienced telaprevir/boceprevir treatment failure Genotype 1a or 1b Treatment J: PSI-7977 + Daclatasvir + Ribavirin PSI-7977 Patients who experienced telaprevir/boceprevir treatment failure Genotype 1a or 1b Treatment B: PSI-7977 + Daclatasvir Daclatasvir Genotype 2 or 3 Treatment A: PSI-7977 + Daclatasvir Daclatasvir Genotype 1a or 1b Treatment E: PSI-7977 + Daclatasvir + Ribavirin Ribavirin Genotype 1a or 1b Treatment C: PSI-7977 + Daclatasvir Daclatasvir Genotype 1a or 1b Treatment D: PSI-7977 + Daclatasvir Daclatasvir Genotype 2 or 3 Treatment H: PSI-7977 + BMS-790052 + Ribavirin Ribavirin Hepatitis C virus genotype 1, treatment-naive patients Genotype 1a or 1b Treatment E: PSI-7977 + Daclatasvir + Ribavirin Daclatasvir Genotype 1a or 1b Treatment G: PSI-7977 + Daclatasvir Daclatasvir Hepatitis C virus genotype 1, treatment-naive patients Genotype 1a or 1b Treatment F: PSI-7977 + Daclatasvir+ Ribavirin Daclatasvir Genotype 2 or 3 Treatment F: PSI-7977 + Daclatasvir+ Ribavirin Ribavirin Genotype 2 or 3 Treatment H: PSI-7977 + BMS-790052 + Ribavirin Daclatasvir Hepatitis C virus genotype 1, treatment-naive patients Genotype 1a or 1b Treatment J: PSI-7977 + Daclatasvir + Ribavirin Daclatasvir Patients who experienced telaprevir/boceprevir treatment failure Genotype 1a or 1b Treatment J: PSI-7977 + Daclatasvir + Ribavirin Ribavirin Patients who experienced telaprevir/boceprevir treatment failure Genotype 1a or 1b
- Primary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12) Follow-up Week 12 SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected (ie, HCV RNA \<25 IU/mL) at follow-up Week 12. DCV=daclatasvir, SOF=sofosbuvir.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24) Follow-up Week 24 SVR24 was defined as participant's hepatitis C virus RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 24. DCV=daclatasvir, SOF=sofosbuvir.
Number of Participants Who Died and With Serious Adverse Events (SAEs), Grade 3-4 Adverse Events (AEs), and Grade 3-4 Abnormalities on Laboratory Test Results During Follow-up Period AEs: From Day 1 of follow-up period (Week 13 or 25) up to study discharge (up to 72 weeks). SAEs: From Day 1 of follow-up period (Week 13 or 25) up to 30 days after study discharge (up to 74 weeks) 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. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe
Percentage of Participants With Viral Breakthrough During the Treatment Period First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group) Viral breakthrough is defined as any confirmed increase in viral load ≥1 log from nadir or any confirmed hepatitis C virus RNA levels ≥25 IU/mL on or after Week 8.
Percentage of Participants Who Experienced Viral Relapse During Follow-up Period Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks) Viral relapse during follow-up is defined as any confirmed quantifiable hepatitis C virus (HCV) RNA ≥25 IU/mL with HCV RNA levels less than the lower limit of quantitation, target detected or target not detected, ie, HCV RNA \<25 IU/mL at the end of treatment.
Change From Baseline in log10 Hepatitis C Virus (HCV) RNA at Follow-up Week 24 Baseline, Follow-up week 24 Change from baseline in log10 HCV RNA at scheduled sampling time.
Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group) 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. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe.
Trial Locations
- Locations (18)
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
Research And Education, Inc.
🇺🇸San Diego, California, United States
University Of Florida Hepatology
🇺🇸Gainesville, Florida, United States
University Of Colorado Denver & Hospital
🇺🇸Aurora, Colorado, United States
University Of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Dean Clinic
🇺🇸Madison, Wisconsin, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
University Of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Local Institution
🇵🇷San Juan, Puerto Rico
Southern California Liver Centers
🇺🇸Coronado, California, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States
Alamo Medical Research
🇺🇸San Antonio, Texas, United States
Johns Hopkins University
🇺🇸Lutherville, Maryland, United States
Bronx Va Medical Center 3c Sub-J
🇺🇸Bronx, New York, United States
Miami Research Associates
🇺🇸South Miami, Florida, United States
Options Health Research, Llc
🇺🇸Tulsa, Oklahoma, United States
Healthcare Research Consultants
🇺🇸Tulsa, Oklahoma, United States
Metropolitan Research
🇺🇸Annandale, Virginia, United States