Hepatitis C Virus (HCV)
Conditions
Brief summary
The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin
Interventions
BIOLOGICALPegylated interferon lambda (pegIFNλ)
Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks
Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks
DRUGRibavirin
Tablets, Oral, 400 mg, Twice daily, 24 weeks
DRUGDaclatasvir
Tablets, Oral, 60 mg, Once daily, 12 weeks
Tablets, Oral, 0 mg, Once daily, 12 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 No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Chronic hepatitis C, Genotype 2 or 3 * Naïve to prior anti-HCV therapy
Exclusion criteria
* Infected with HCV other than Genotype 2 or 3 * Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening * Evidence of liver disease other than HCV * Active substance abuse * Evidence of decompensated cirrhosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects who achieve Sustained Virologic Response at post-treatment follow-up week 12 (SVR12) | Post-treatment follow-up week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, neutropenia as defined by ANC < 750 mm3 or thrombocytopenia as defined by platelets < 50,000 mm3) | Up to week 12 or week 24 | Hb = Hemoglobin ANC = Absolute neutrophil count |
| Proportion of subjects with on-treatment interferon-associated flu-like symptoms (as defined by pyrexia or chills or pain) | Up to week 12 or week 24 | — |
| Proportion of subjects with on-treatment musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain) | Up to week 12 or week 24 | — |
| Proportion of subjects with Sustained Virologic Response at post-treatment follow-up week 24 (SVR24) by treatment group | Post-treatment week 24 | — |
| Proportion of subjects with Rapid virologic response (RVR) [undetectable Hepatitis C virus (HCV) Ribonucleic acid (RNA)] | On-treatment Week 4 | — |
| Proportion of subjects with dose reductions | Up to week 12 or week 24 | — |
| Proportion of subjects who discontinue due to Adverse events (AEs) | Up to week 12 or week 24 | — |
| Proportion of subjects with SVR12 in subjects with genotype-3 (GT-3) chronic HCV infection | Post-treatment follow-up week 12 | — |
| Proportion of subjects with on-treatment constitutional symptoms (fatigue or asthenia) | Up to week 12 or week 24 | — |
| Proportion of subjects with on-treatment Serious adverse events (SAEs) | Up to week 12 or week 24 | — |
Countries
Argentina, Australia, Belgium, Chile, Finland, France, Greece, Hong Kong, Italy, Japan, Mexico, Netherlands, New Zealand, Russia, Singapore, South Korea, Taiwan, United Kingdom, United States
Outcome results
None listed