Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Hepatitis C Virus

Treatments: Drug: Daclatasvir; Drug: Pegylated interferon alfa-2a; Drug: Ribavirin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01257204

AI444-031

2010-022408-28 (EudraCT Number)

Details and patient eligibility

About

To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and ribavirin.

Enrollment: 196 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Participants chronically infected with hepatitis C virus (HCV) genotype 2 or 3
• No previous exposure to an interferon formulation (ie, interferon alfa, pegylated interferon alfa-2a ) or ribavirin
• Body mass index (BMI) of 18 to 35 kg/m^2, inclusive. BMI=weight (kg)/height (m)^2
• Males and females, 18 - 70 years of age

Key Exclusion Criteria:

• Liver transplant recipients
• Documented or suspected hepatocellular carcinoma
• Evidence of decompensated cirrhosis
• History of chronic hepatitis B virus (HBV). Patients with resolved HBV infection may participate
• Current or known history of cancer
• Any gastrointestinal disease or surgical procedure that may impact the absorption of study drug
• Inability to tolerate oral medication
• Poor venous access
• Severe psychiatric disease
• History of chronic pulmonary disease
• History of cardiomyopathy, coronary artery disease (including angina), interventive procedure for coronary artery disease (including angioplasty, stent procedure, or cardiac bypass surgery), ventricular arrhythmia,, or other clinically significant cardiac disease
• History of or current electrocardiogram findings indicative of cardiovascular instability
• Preexisting ophthalmologic disorders considered clinically significant on eye
• History of uncontrolled diabetes mellitus
• Any known contraindication to pegylated interferon alfa-2a or ribavirin not otherwise specified.
• Positive hepatitis B virus surface antigen, HIV-1 or HIV-2 Ab
• Prior exposure to any HCV direct antiviral agent (eg, HCV protease, polymerase, previous nonstructural protein 5A inhibitors)
• Exposure to any investigational drug or placebo

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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196 participants in 3 patient groups

Control

Active Comparator group

Description:

Placebo + Pegylated interferon alfa-2a + Ribavirin

Treatment:

Drug: Placebo

Drug: Ribavirin

Drug: Pegylated interferon alfa-2a

12 Week Cohort

Experimental group

Description:

Daclatasvir + Pegylated interferon alfa-2a + Ribavirin

Treatment:

Drug: Ribavirin

Drug: Pegylated interferon alfa-2a

Drug: Daclatasvir

16 Week Cohort

Experimental group

Description:

Daclatasvir + Pegylated interferon alfa-2a + Ribavirin

Treatment:

Drug: Ribavirin

Drug: Pegylated interferon alfa-2a

Drug: Daclatasvir