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



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:4/21/2016
Start Date:December 2010
End Date:September 2012

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A Phase 2B Pilot Study of Short-Term Treatment of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 2 or 3 Infection

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


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
We found this trial at
5
sites
Baltimore, Maryland 21229
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Baltimore, MD
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Darlinghurst, New South Wales
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Darlinghurst,
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Los Angeles, California 90048
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Los Angeles, CA
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San Antonio, Texas 78215
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San Antonio, TX
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Tulsa, Oklahoma 74137
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Tulsa, OK
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