Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
Phase 2
Completed
- Conditions
- Hepatitis C
- Interventions
- Registration Number
- NCT01795911
- Lead Sponsor
- Bristol-Myers Squibb
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 165
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Substudy C: Pegylated Interferon Lambda+Ribasphere+Daclatasvir Ribasphere Pegylated Interferon Lambda 180 μg Solution, Subcutaneous Once weekly for 12 weeks; Ribasphere 1000 mg for subjects weighing \< 75 kg and 1200 mg for subjects weighing ≥ 75 kg oral tablets per day \[subjects should take either 400 mg for subjects \< 75 kg or 600 mg ≥ 75 kg in the morning with food and 600 mg in the evening with food\] for 12 weeks; Daclatasvir 60 mg oral tablet Once daily for 12 weeks Substudy C: Pegylated Interferon Lambda+Ribasphere+Daclatasvir Pegylated Interferon Lambda Pegylated Interferon Lambda 180 μg Solution, Subcutaneous Once weekly for 12 weeks; Ribasphere 1000 mg for subjects weighing \< 75 kg and 1200 mg for subjects weighing ≥ 75 kg oral tablets per day \[subjects should take either 400 mg for subjects \< 75 kg or 600 mg ≥ 75 kg in the morning with food and 600 mg in the evening with food\] for 12 weeks; Daclatasvir 60 mg oral tablet Once daily for 12 weeks Substudy C: Pegylated Interferon Lambda+Ribasphere+Daclatasvir Daclatasvir Pegylated Interferon Lambda 180 μg Solution, Subcutaneous Once weekly for 12 weeks; Ribasphere 1000 mg for subjects weighing \< 75 kg and 1200 mg for subjects weighing ≥ 75 kg oral tablets per day \[subjects should take either 400 mg for subjects \< 75 kg or 600 mg ≥ 75 kg in the morning with food and 600 mg in the evening with food\] for 12 weeks; Daclatasvir 60 mg oral tablet Once daily for 12 weeks
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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
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 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 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
Trial Locations
- Locations (1)
Alamo Medical Research
🇺🇸San Antonio, Texas, United States