A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection

Bristol-Myers Squibb207 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

207

Conditions

Hepatitis C

Interventions

DaclatasvirDRUG

Daclatasvir tablet 60mg

AsunaprevirDRUG

Asunaprevir soft capsule 100 mg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (29)

Local Institution

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Proportion of treated subjects randomized to Active Dual therapy with Sustained Virologic Response (SVR12)

HCV RNA \< Lower limit of quantitation (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12

Time frame: Post-treatment Week 12

Secondary Outcomes

Proportion of subjects with anemia on active Dual therapy

Time frame: Post-treatment Week 12

Proportion of subjects with neutropenia on active Dual therapy

Time frame: Post-treatment Week 12

Proportion of subjects with thrombocytopenia on active Dual therapy

Time frame: Post-treatment Week 12

On treatment safety, as measured by frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)

Time frame: Post-treatment week 12

Differences in rates of selected Grade 3-4 laboratory abnormalities for hematology between treatments (DCV + Asunaprevir (ASV) vs PBO)

Time frame: first 12 weeks on treatment

Differences in rates of selected Grade 3-4 laboratory abnormalities for liver function between treatments (DCV + Asunaprevir (ASV) vs PBO)

Time frame: first 12 weeks on treatment

Proportion of subjects with SVR12 by the rs12979860 single nucleotide polymorphism (SNP) in the interleukin (IL) -28B gene for each cohort

Time frame: 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

Data from ClinicalTrials.gov

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