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

Completed · Phase 2

Conditions studied: Chronic Hepatitis C

In brief

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 1 \& Genotype 4 treatment naive patients, and Genotype (GT1) infected patients who are prior null responders to pegIFN/ribavirin

Key facts

Study ID

NCT01455090

Run by

Bristol-Myers Squibb

People needed

320

Starts

2011-11-30

Expected to finish

2015-07-31

Last updated by the study team

2017-04-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Kirklin Clinic — Birmingham, Alabama, United States
• Southern California Research Center — Coronado, California, United States
• Peter J Ruane Md Inc — Los Angeles, California, United States
• Va Greater Los Angeles Healthcare System — Los Angeles, California, United States
• Research And Education, Inc. — San Diego, California, United States
• Precision Research Institute, Llc — San Diego, California, United States
• Medical Associates Research Group — San Diego, California, United States
• University Of Colorado Denver And Hospital — Aurora, Colorado, United States
• Medstar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Orlando Immunology Center — Orlando, Florida, United States
• Miami Research Associates — South Miami, Florida, United States
• Atlanta Gastroenterology Associates, Llc — Atlanta, Georgia, United States
• Mercy Medical Center, Inc. — Baltimore, Maryland, United States
• Johns Hopkins University — Lutherville, Maryland, United States
• Id Care — Hillsborough, New Jersey, United States
• Southwest Care Center — Santa Fe, New Mexico, United States
• James J Peters Vamc — The Bronx, New York, United States
• Options Health Research, Llc — Tulsa, Oklahoma, United States
• Healthcare Research Consultants — Tulsa, Oklahoma, United States
• Texas Clinical Research Institute — Arlington, Texas, United States
• Research Specialists Of Texas — Houston, Texas, United States
• Alamo Medical Research — San Antonio, Texas, United States
• Lifetree Clinical Research — Salt Lake City, Utah, United States
• Metropolitan Research — Fairfax, Virginia, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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