Hepatitis C
Conditions
Brief summary
The purpose of this study is to determine whether a regimen consisting of daclatasvir and asunaprevir is effective in treatment-naive patients with chronic hepatitis genotype 1b infection.
Interventions
DRUGDaclatasvir
Daclatasvir tablet 60mg
DRUGAsunaprevir
Asunaprevir soft capsule 100 mg
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: * Patients chronically infected with HCV Genotype 1b * No previous exposure to any interferon formulation, Ribavirin (RBV), and HCV direct acting antiviral agent * HCV RNA viral load ≥ 10,000 IU/mL at screening * Seronegative for HIV and HBsAg * BMI of 18-35 kg/m2, inclusive * Patients with compensated cirrhosis are permitted
Exclusion criteria
* Infection with HCV other than genotype (GT) -1b * Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy * Evidence of a medical condition contributing to chronic liver disease other than HCV * Diagnosed or suspected hepatocellular carcinoma or other malignancies * Uncontrolled diabetes or hypertension * History of moderate to severe depression. Well-controlled mild depression is allowed * Confirmed alanine aminotransferase (ALT) ≥ 5x Upper Limit of Normal (ULN) * Confirmed platelet count \< 50,000 cells/mm3 * Confirmed hemoglobin \< 8.5 g/dL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of treated subjects randomized to Active Dual therapy with Sustained Virologic Response (SVR12) | Post-treatment Week 12 | HCV RNA \< Lower limit of quantitation (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with neutropenia on active Dual therapy | Post-treatment Week 12 |
| Proportion of subjects with thrombocytopenia on active Dual therapy | Post-treatment Week 12 |
| On treatment safety, as measured by frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) | Post-treatment week 12 |
| Differences in rates of selected Grade 3-4 laboratory abnormalities for hematology between treatments (DCV + Asunaprevir (ASV) vs PBO) | first 12 weeks on treatment |
| Proportion of subjects with anemia on active Dual therapy | Post-treatment Week 12 |
| Proportion of subjects with SVR12 by the rs12979860 single nucleotide polymorphism (SNP) in the interleukin (IL) -28B gene for each cohort | Post-treatment visit week 12 |
| Proportion of subjects with hepatitis C virus (HCV) RNA < LLOQ-TD/TND in each arm at various intervals after the initiation of active Dual therapy | post-treatment visit Week 24 |
| Proportion of subjects who achieve HCV RNA < LLOQ-TND at each arm at various intervals after the initiation of active Dual therapy | post-treatment visit Week 24 |
| Proportion of treated subjects with SVR12 for subjects randomized to placebo | Post-treatment visit week 12 |
| Differences in rates of selected Grade 3-4 laboratory abnormalities for liver function between treatments (DCV + Asunaprevir (ASV) vs PBO) | first 12 weeks on treatment |
Countries
China, Russia, South Korea
Outcome results
None listed