Hepatitis C Virus (HCV) Clinical Trial
— BASISOfficial title:
A Double-Blinded, Randomized Control Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naive Genotype 1 Chronic Hepatitis C Subjects
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Czech Republic | Local Institution | Hradec Kralove | |
Czech Republic | Local Institution | Praha 4 | |
Czech Republic | Local Institution | Usti Nad Labem | |
Korea, Republic of | Local Institution | Chungcheongnam-do | |
Korea, Republic of | Local Institution | Daegu | |
Korea, Republic of | Local Institution | Gangwon-do | |
Korea, Republic of | Local Institution | Gyeonggi-do | |
Korea, Republic of | Local Institution | Gyeonggi-do | |
Korea, Republic of | Local Institution | Gyeongsangnam-do | |
Korea, Republic of | Local Institution | Incheon | |
Korea, Republic of | Local Institution | Seoul | |
Mexico | Local Institution | Distrito Federal | |
Mexico | Local Institution | Guadalajara | Jalisco |
Mexico | Local Institution | Guadalajara | Jalisco |
Mexico | Local Institution | Mexico | Distrito Federal |
Mexico | Local Institution | Mexico City | Estado De Mexico |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
Czech Republic, Korea, Republic of, Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | ANC = Absolute Neutrophil Count Hb = Hemoglobin |
Up to 48 weeks of treatment | Yes |
Secondary | 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 | No | |
Secondary | Proportion of subjects with Rapid Virologic Response (RVR) (HCV RNA not detected) | On treatment Week 4 (of an up to 48-week treatment period) | No | |
Secondary | Proportion of subjects with on-treatment Serious Adverse Events (SAEs) through end of treatment | Up to 48 weeks of treatment | Yes | |
Secondary | Proportion of subjects with dose reductions through end of treatment | Up to 48 weeks of treatment | Yes | |
Secondary | Proportion of subjects who discontinue due to Adverse Events (AEs) through end of treatment | Up to 48 weeks of treatment | Yes | |
Secondary | Proportion of subjects with on-treatment Interferon (IFN)-associated symptoms as determined by adverse event reporting | 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) |
Up to 48 weeks of treatment | Yes |
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