Safety and Efficacy Study of Peginterferon Lambda-1a vs. Peginterferon Alfa-2a, Plus Ribavirin in Subjects With Genotype 1 Hepatitis C
Phase 3
Completed
- Conditions
- Hepatitis C Virus (HCV)
- Interventions
- Registration Number
- NCT01754974
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to determine if 48 weeks of therapy with Peginterferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Peginterferon alfa-2a plus Ribavirin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Chronic hepatitis C, Genotype 1
- HCV RNA ≥100,000 IU/mL at screening
- Liver biopsy documenting no cirrhosis (within prior 3 years). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease
- Naïve to prior anti-HCV therapy
Exclusion Criteria
- Infected with HCV other than Genotype 1
- Positive Hepatitis B Surface Antigen (HBsAg), or Human Immunodeficiency Virus (HIV)-1/HIV-2 antibody 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 history of cirrhosis based on radiologic criteria or biopsy results and clinical criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Peginterferon alfa-2a + Ribavirin Peginterferon alfa-2a Peginterferon alfa-2a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks Peginterferon Lambda-1a + Ribavirin Ribavirin Peginterferon Lambda-1a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks Peginterferon Lambda-1a + Ribavirin Peginterferon Lambda-1a Peginterferon Lambda-1a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks Peginterferon alfa-2a + Ribavirin Ribavirin Peginterferon alfa-2a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks
- Primary Outcome Measures
Name Time Method Proportion of subjects who develop treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, and/or neutropenia as defined by ANC < 750 mm3 and/or thrombocytopenia as defined by platelets < 50,000 mm3) in treatment-naive subjects Up to 48 weeks of treatment * ANC = Absolute Neutrophil Count
* Hb = Hemoglobin
- Secondary Outcome Measures
Name Time Method Proportion of subjects who discontinue due to Adverse Events (AEs) through end of treatment Up to 48 weeks of treatment Proportion of subjects with Sustained Virologic Response at Post-Treatment Follow-up Week 24 (SVR24), defined as Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < Lower Limit of Quantitation of Assay (LLOQ) At Post-Treatment Follow-up Week 24 Proportion of subjects with Rapid Virologic Response (RVR) (HCV RNA not detected) On treatment Week 4 (of an up to 48-week treatment period) Proportion of subjects with on-treatment Serious Adverse Events (SAEs) through end of treatment Up to 48 weeks of treatment Proportion of subjects with dose reductions through end of treatment Up to 48 weeks of treatment Proportion of subjects with on-treatment Interferon (IFN)-associated symptoms as determined by adverse event reporting Up to 48 weeks of treatment On-treatment IFN-associated symptoms are:
* Flu-like symptoms (as defined by pyrexia or chills or pain)
* Musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain)
* Neurological symptoms (headache or dizziness)
* Constitutional symptoms (fatigue or asthenia)
* Psychiatric symptoms (depression or irritability or insomnia)
Trial Locations
- Locations (1)
Local Institution
🇲🇽Distrito Federal, Mexico