Status:
COMPLETED
Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to estimate the rate of sustained virologic response (SVR) SVR12, where SVR12 is defined as HCV RNA \< LOQ (detectable or undetectable) 12 weeks post-treatment in Genotype...
Detailed Description
IND numbers: 79,599; 101,943
Eligibility Criteria
Inclusion
- Men and women, ages ≥18 years of age
- Subjects who are naive to HCV treatment, defined as no previous exposure to an Interferon (IFN), Ribavirin (RBV); or any HCV-specific direct acting antiviral or experimental therapy or subjects who are null responders to previous pegylated Interferon alfa (pegIFNα) plus Ribavirin (RBV) treatment
- Subjects should have chronic hepatitis C (CHC) as documented by:
- Positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to screening, and positive for HCV RNA and Anti-HCV antibody at the time of screening, or
- Positive for anti-HCV antibody and HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed prior to enrollment with evidence of CHC disease, such as the presence of fibrosis)
- HCV genotype 1a, 1b or 4 only
- HCV RNA viral load of ≥10,000 IU/mL at screening
- Have one of the following:
- Documented Fibrotest score of ≤0.72 and aspartate transferase (transminase) to platelet ratio index (APRI) ≤2; OR
- Documented liver biopsy within 36 months preceding Day 1 showing absence of cirrhosis OR
- Documented Fibroscan® ultrasound (where approved) within 12 months of screening showing absence of cirrhosis
- Body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive
- Subjects with compensated Child-Pugh A cirrhosis as documented by history of cirrhosis with any prior liver biopsy or Fibroscan® ultrasound (where approved) within 12 months prior to screening
Exclusion
- Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis,metabolic liver disease, alcoholic liver disease, toxin exposures)
- History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis
- Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
- Documented or suspected hepatocellular carcinoma (HCC)
- Positive for hepatitis B surface antigen (HBsAg)
- Positive for Human Immunodeficiency Virus-1 (HIV-1) and/or Human Immunodeficiency Virus-2 (HIV-2) antibodies
- Alanine transferase (transminase) (ALT) \>5x upper limit of normal (ULN)
- Total Bilirubin ≥2 mg/dL
Key Trial Info
Start Date :
November 30 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2015
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT01455090
Start Date
November 30 2011
End Date
July 31 2015
Last Update
April 27 2017
Active Locations (32)
Enter a location and click search to find clinical trials sorted by distance.
1
The Kirklin Clinic
Birmingham, Alabama, United States, 35294
2
Southern California Research Center
Coronado, California, United States, 92118
3
Peter J Ruane Md Inc
Los Angeles, California, United States, 90036
4
Va Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073