Hepatitis C
Conditions
Brief summary
Substudy C: The purpose of this substudy is to determine whether Lambda combined with Ribavirin and Daclatasvir for 12 weeks is efficacious in treatment naïve subjects with genotype 1b chronic HCV infection
Interventions
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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; * Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg); * Liver biopsy within prior 2 years; subjects with compensated cirrhosis can enroll and will be capped at approximately 10%
Exclusion criteria
* Any evidence of liver disease other than HCV; * Co-infection with HIV; * Diagnosed or suspected hepatocellular carcinoma; * Medical history or laboratory value abnormalities that would prohibit the use of Pegylated Interferon Alpha-2a or Ribavirin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antiviral activity, as determined by the proportion of non-cirrhotic HCV GT-1b subjects with 12-week sustained virologic response (SVR12), defined as HCV RNA < LLOQ target detected or not detected | Post-treatment Week 12 | HCV = Hepatitis C virus; GT = Geno Type; RNA = Ribonucleic acid; LLOQ = Lower limit of quantitation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of non-cirrhotic HCV GT-1b subjects with 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) on treatment | On-treatment Weeks 1, 2, 4, 8, and 12 | Hb = Hemoglobin; ANC = Absolute neutrophil count |
| Proportion of non-cirrhotic HCV GT-1b subjects with on-treatment (maximum of 12 weeks) interferon-associated flu-like symptoms (pyrexia or chills or pain) | On-treatment Weeks 1, 2, 4, 8, and 12 | — |
| Proportion of non-cirrhotic HCV GT-1b subjects with on-treatment (maximum of 12 weeks) interferon-associated musculoskeletal symptoms (arthralgia or myalgia or back pain) | On-treatment Weeks 1, 2, 4, 8, and 12 | — |
| Proportion of non-cirrhotic HCV GT-1b subjects with SVR24, defined as HCV RNA < LLOQ target detected or not detected | Post-treatment follow-up Week 24 | — |
| Frequency of deaths among non-cirrhotic HCV GT-1b subjects through the end of follow-up (maximum of 60 weeks) | On-treatment Weeks 1, 2, 4, 8, and 12 and post-treatment weeks 4, 12, 24, 36 and 48 | — |
| Frequency of Serious adverse events (SAEs) among non-cirrhotic HCV GT-1b subjects through the end of follow-up (maximum of 60 weeks) | On-treatment Weeks 1, 2, 4, 8, and 12 and post-treatment weeks 4, 12, 24, 36 and 48 | — |
| Proportion of non-cirrhotic HCV GT-1b subjects with eRVR, defined as HCV RNA < LLOQ target not detected | At Week 4 and Week 12 | eRVR = Extended rapid virologic response |
| Frequency of dose reductions and discontinuations due to AEs among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks) | On-treatment Weeks 1, 2, 4, 8, and 12 | — |
| Frequency of treatment emergent laboratory abnormalities among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks) | On-treatment Weeks 1, 2, 4, 8, and 12 | — |
| Proportion of non-cirrhotic HCV GT-1b subjects with interferon-associated constitutional symptoms (fatigue or asthenia) through the end of treatment (maximum of 12 weeks) | On-treatment Weeks 1, 2, 4, 8, and 12 | — |
| Proportion of non-cirrhotic HCV GT-1b subjects with interferon-associated neurologic symptoms (headache or dizziness) through the end of treatment (maximum of 12 weeks) | On-treatment Weeks 1, 2, 4, 8, and 12 | — |
| Proportion of non-cirrhotic HCV GT-1b subjects with psychiatric symptoms (depression or irritability or insomnia) through the end of treatment (maximum of 12 weeks) | On-treatment Weeks 1, 2, 4, 8, and 12 | — |
| Frequency of drug related Adverse events (AEs) among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks) | On-treatment Weeks 1, 2, 4, 8, and 12 | — |
Countries
United States
Outcome results
None listed