Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia
- Conditions
- Hepatitis C Virus
- Interventions
- Registration Number
- NCT01741545
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA \< LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with Genotype(GT)-1b, -4 and GT-2, -3
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 71
- Severe hemophilia (defined as < 1% factor activity level)
- Infection with the hepatitis C virus (HCV) with underlying hemophilia
- Males 18 years of age and above
- Have not been previously treated with an interferon
- Not infected with the hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Chronic liver disease caused by any disease other than chronic HCV infection
- Presence of Bethesda inhibitor
- Current evidence of or history of portal hypertension
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A: Genotype-2,-3 (Lambda/RBV/DCV) Ribavirin Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 12 weeks Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 12 weeks Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks Cohort B: Genotype-1b,-4 (Lambda/RBV/DCV) Pegylated-Interferon-lambda Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 24 weeks Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 24 weeks Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks Cohort A: Genotype-2,-3 (Lambda/RBV/DCV) Pegylated-Interferon-lambda Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 12 weeks Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 12 weeks Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks Cohort B: Genotype-1b,-4 (Lambda/RBV/DCV) Daclatasvir Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 24 weeks Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 24 weeks Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks Cohort A: Genotype-2,-3 (Lambda/RBV/DCV) Daclatasvir Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 12 weeks Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 12 weeks Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks Cohort B: Genotype-1b,-4 (Lambda/RBV/DCV) Ribavirin Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 24 weeks Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 24 weeks Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Achieved Sustained Virologic Response (SVR12) at Follow-Up Week 12 Follow-up Week 12 SVR12 was defined as HCV ribonucleic acid (RNA) less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Flu-Like Symptoms and Musculoskeletal Symptoms On-Treatment After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B) Flu-like symptoms were defined as pyrexia or chills or pain. Musculoskeletal symptoms were defined as arthralgia or myalgia or back pain.
Percentage of Participants With Complete Early Virologic Response (cEVR) Treatment Week 12 cEVR was defined as HCV RNA less than the lower limit of quantitation, target not detected at Week 12.
Percentage of Participants With Rapid Virologic Response (RVR) Treatment Week 4 RVR was defined as HCV RNA less than the lower limit of quantitation, target not detected at Week 4.
Percentage of Participants With End of the Treatment Response (EOTR) End of the treatment (Week 12 for Cohort A, Week 24 for Cohort B) EOTR was defined as HCV RNA less than the lower limit of quantitation, target not detected at end of treatment.
Number of Participants With Treatment Emergent Grade 3 to 4 Laboratory Abnormalities After day 1 to to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B) Laboratory abnormalities were determined and graded using the Division of acquired immunodeficiency syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0. International Normalized Ratio (INR): \>2.0\*Upper limit of normal (ULN); Alanine aminotransferase (ALT) : \>5\*ULN; Aspartate aminotransferase (AST): \>5\*ULN; Prothrombin Time (PT): \>1.50\*ULN; Bilirubin (Total): \>2.5\*ULN; Triglycerides (fasting): \>750 mg/dL.
Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24) Follow-up Week 24 SVR24 was defined as HCV RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24.
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Dose Reductions, And Death From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B) AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug.
Percentage of Participants With Treatment-Emergent Cytopenic Abnormalities On-Treatment After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B) Cytopenic abnormalities were defined as anemia: Hemoglobin (Hb) \<10 g/dL, and/or neutropenia: absolute neutrophils and bands (ANC) \<750 mm\^3, and/or thrombocytopenia: platelets \<50,000 mm\^3.
Trial Locations
- Locations (5)
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Hospital Of The University Of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Stanford Boswell Clinic
🇺🇸Palo Alto, California, United States
Clinical Research Centers Of America
🇺🇸Murray, Utah, United States
Local Institution
🇪🇸Sevilla, Spain