Hepatitis C Virus (HCV)
Conditions
Brief summary
The purpose of this study is to determine if 48 weeks of therapy with Pegylated Interferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Pegylated Interferon Alfa-2a plus Ribavirin.
Interventions
BIOLOGICALPegylated Interferon Lambda
Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks
BIOLOGICALPegylated Interferon Alfa-2a
Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks
DRUGRibavirin
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Chronic hepatitis C, Genotype 1 or 4 * HCV Ribonucleic acid (RNA) ≥ 100,000 IU/mL at screening * Liver biopsy documenting no cirrhosis (within prior 2 years) or cirrhosis (from any time prior to randomization). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease. Subjects with compensated cirrhosis can enroll and will be capped at 10% * Naive to prior anti-HCV therapy
Exclusion criteria
* Infected with HCV other than Genotype 1 or 4 * Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody or hepatitis D virus (HDV) at screening * Evidence of liver disease other than HCV * Active substance abuse * Use of hematologic growth factors within 90 days prior to study randomization * Evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of Lambda + Ribavirin (RBV) compared to Alfa + RBV in achieving a sustained virological response | At follow-up Week 24 (SVR24) following 48 weeks of treatment |
| The safety of Lambda + RBV compared to Alfa + RBV in reducing cytopenic abnormalities | From Day 1 to end of Week 48 on-treatment |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of interferon-associated symptoms: a) Flu-like symptoms b) Musculoskeletal symptoms c) Neurologic symptoms d) Psychiatric symptoms e) Constitutional symptoms | From Day 1 to end of Week 48 on-treatment |
Countries
Canada, China, Colombia, Czechia, Egypt, Hong Kong, Hungary, India, Ireland, Netherlands, Poland, Romania, Russia, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed