Hepatitis C Virus (HCV)
Conditions
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.
Interventions
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 who discontinue due to Adverse Events (AEs) 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) |
| Proportion of subjects with dose reductions through end of treatment | Up to 48 weeks of treatment | — |
Countries
Czechia, Mexico, South Korea
Outcome results
None listed