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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: Asunaprevir; Drug: Daclatasvir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02496078

AI447-114

Details and patient eligibility

About

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.

Enrollment: 207 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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207 participants in 2 patient groups, including a placebo group

Active dual arm

Active Comparator group

Description:

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

Treatment:

Drug: Asunaprevir

Drug: Daclatasvir

Placebo arm

Placebo Comparator group

Description:

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

Treatment:

Drug: Asunaprevir

Drug: Daclatasvir