Hepatitis C
Conditions
Brief summary
The purpose of this study is to determine whether 24 week treatment with the Daclatasvir (DCV) in combination with Pegylated-interferon alfa 2a (pegIFNα-2a) and Ribavirin (RBV) is safe and demonstrates rate of Sustained Virologic Response at follow up week 24 (SVR24) (defined as undetectable HCV RNA at post-treatment Week 24) that are non-inferior to 48 weeks of the dual combination therapy of pegIFNα-2a/RBV in a majority of study subjects
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Patients chronically infected with Hepatitis C virus (HCV) GT 1 or 4 * HCV RNA viral load ≥ 10,000 IU/mL * Naïve to prior treatment with any interferon formulation, Ribavirin (RBV) or HCV direct antiviral agent * Patients with compensated cirrhosis are permitted
Exclusion criteria
* Infected with HCV other than GT 1 or 4 * Evidence of decompensated liver disease * Documented or suspected Hepatocellular carcinoma (HCC) as evidenced by previously obtained imaging studies or liver biopsy * Evidence of a medical condition contributing to chronic liver disease other than HCV * History of chronic Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV) * Current or know history of cancer (except in situ carcinoma of cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment * Laboratory values: 1. Hemoglobin \< 12 g/dL (females) or \< 13 g/dL (males) 2. Platelets \< 90 x 1000000000 cells/L 3. Absolute neutrophil count (ANC) \< 1.5 × 1000000000 cells/L 4. Total bilirubin ≥ 34 µmol/L (unless due to Gilbert's disease)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Genotype 1 subjects with SVR24, defined as HCV RNA < Limit of quantification (LOQ) at follow-up Week 24 for each cohort | Week 24 post treatment follow up |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Genotype (GT) 4 subjects with SVR24 | Week 24 post treatment follow up visit |
| Proportion of GT 1 & 4 subjects who achieve HCV RNA < LOQ or undetectable | Week 24 post treatment follow up visit and Week 48 post treatment follow up visit for subjects who achieve Virologic response [VR] (4&12) |
| Frequency of Serious Adverse Events (SAEs)/discontinuations due to Adverse Events (AEs) | Up to 48 weeks plus 30 days |
| Discontinuations due to Adverse Events (AEs) | Up to 48 weeks plus 7 days |
| Proportion of subjects with Sustained Virologic Response at follow up week 12 (SVR12) or SVR24 by rs12979860 Single nucleotide polymorphism (SNP) in the IL28B gene | Up to 72 weeks |
Outcome results
None listed