Overview

This trial is active, not recruiting.

Condition hepatitis c
Treatments daclatasvir, asunaprevir
Phase phase 3
Sponsor Bristol-Myers Squibb
Start date August 2015
End date August 2016
Trial size 200 participants
Trial identifier NCT02496078, AI447-114

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Daclatasvir in tablet form at the dose of 60 mg QD and Asunaprevir in soft capsule form at the dose of 100 mg BID from day 1 to 12 week Daclatasvir in tablet form at the dose of 60 mg QD and Asunaprevir in soft capsule form at the dose of 100 mg BID from 12 to 24 week and follow up to week 48
daclatasvir
Daclatasvir tablet 60mg
asunaprevir
Asunaprevir soft capsule 100 mg
(Placebo Comparator)
Daclatasvir placebo in tablet form QD and Asunaprevir placebo in soft capsule form BID from day 1 to 12 week Daclatasvir in tablet form at the dose of 60 mg QD and Asunaprevir in soft capsule form at the dose of 100 mg BID from 12 to 36 week and follow up to week 60
daclatasvir
Daclatasvir tablet 60mg
asunaprevir
Asunaprevir soft capsule 100 mg

Primary Outcomes

Measure
Proportion of treated subjects randomized to Active Dual therapy with Sustained Virologic Response (SVR12)
time frame: Post-treatment Week 12

Secondary Outcomes

Measure
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
time frame: 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
time frame: post-treatment visit Week 24
Proportion of treated subjects with SVR12 for subjects randomized to placebo
time frame: Post-treatment visit week 12

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.