Status:
COMPLETED
Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis C Virus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and ribavirin.
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT01257204
Start Date
December 1 2010
End Date
September 1 2012
Last Update
December 14 2015
Active Locations (26)
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1
California Liver Institute
Los Angeles, California, United States, 90048
2
Digestive Disease Associates, P.A.
Baltimore, Maryland, United States, 21229
3
Options Health Research, Llc
Tulsa, Oklahoma, United States, 74104
4
Alamo Medical Research
San Antonio, Texas, United States, 78215