Hepatitis C
Conditions
Brief summary
The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a, given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective as the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in subjects who are infected with Chronic Hepatitis C virus genotype 1b and have never received any prior anti-HCV treatment, or who have relapsed after an initial, successful treatment with Pegylated Interferon Alfa + Ribavirin
Interventions
BIOLOGICALPeginterferon Lambda-1a
BIOLOGICALPeginterferon Alfa-2a
DRUGRibavirin
DRUGDaclatasvir
DRUGTelaprevir
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients chronically infected with HCV Genotype-1b * Naïve to prior treatment or documented evidence of relapse after completion of the prescribed duration of treatment (duration may be 24 or 48 weeks, to be determined based upon local guidelines) * HCV RNA viral load ≥100,000 IU/mL at screening * Patients with compensated cirrhosis are permitted
Exclusion criteria
* Infection with Hepatitis C virus (HCV) other than Genotype-1b * Positive Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus (HIV)-1/HIV-2 antibody test at screening * Evidence of chronic liver disease caused by diseases other than chronic HCV infection * Current evidence of or history of variceal bleeding, hepatic encephalopathy, or ascites requiring diuretics or paracentesis or evidence of any of these findings on physical examination performed at screening * Current or known history of cancer (except adequately treated in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin) within 5 years prior to screening * Current evidence or known history of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria * Laboratory values: 1. Hemoglobin \<12.0 g/dL (males) or \<11.0 g/dL (females) 2. Platelets \<90,000/mm3 3. Total serum bilirubin ≥2 mg/dL (unless due to Gilbert's disease)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with 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 rash related dermatologic events | Up to 12 weeks of treatment | — |
| Proportion of subjects who develop treatment emergent cytopenic abnormalities | Up to 48 Weeks | Treatment emergent cytopenic abnormalities \[anemia as defined by Hemoglobin (Hb) \< 10 g/dL, and/or neutropenia as defined by absolute neutrophil count (ANC) \< 750/mm3, and or thrombocytopenia as defined by platelets \< 50,000/mm3\] |
| Proportion of subjects with on-treatment interferon (IFN) associated flu like/musculoskeletal symptoms | Up to 48 Weeks | — |
| Proportion of subjects who achieve SVR24 [Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Lower limit of quantitation (LLOQ)] at post-treatment follow-up Week 24 | Post treatment follow-up Week 24 | SVR24 = Sustained virologic response at post treatment follow-up Week 24 |
| Proportion of subjects with adverse events (AEs), Serious adverse events (SAEs), dose reductions, and discontinuations due to AEs through end of follow-up | Maximum of 72 weeks | — |
| Proportion of subjects who achieve SVR12 with a 24-week treatment regimen | Post treatment follow-up Week 12 | — |
| Proportion of subjects who achieve SVR12 in treatment-naive subjects | Post treatment follow-up Week 12 | — |
| Patient Health Questionnaire-9 (PHQ-9) score through end of follow-up | Maximum of 72 weeks | — |
| Proportion of subjects with treatment emergent laboratory abnormalities by toxicity grade through End of treatment (EOT) | Maximum of 72 weeks | — |
| Proportion of subjects with the following on-treatment interferon-associated neuropsychiatric symptoms through EOT | Maximum of 48 weeks | Psychiatric symptoms (depression, irritability or insomnia) |
| Association of Single nucleotide polymorphism (SNPs) in Interleukin 28B (IL28B) (including rs12979860) or equilibrative nucleoside transporter 1 (ENT1) with clinical responses | Post-treatment follow-up Week 12 | For each SNP in each candidate gene, allele and genotype frequencies will be summarized by treatment regimen |
| Resistant variants associated with virologic failure through end of follow-up | Maximum of 72 weeks | — |
| Proportion of subjects who achieve Extended rapid virologic response (eRVR) (HCV RNA < LLOQ target not detected at Weeks 4 and 12 of treatment) | Weeks 4 and 12 of treatment | — |
Countries
Argentina, France, Germany, Israel, Italy, Japan, Poland, Russia, South Korea, Spain, Taiwan, United Kingdom, United States
Outcome results
None listed