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
Saves the questions and what to expect into your notes, next to the visit they belong to.
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Lead
Bristol-Myers Squibb
IND numbers: 79,599; 101,943
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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:
1. 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
2. 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:
1. Documented Fibrotest score of ≤0.72 and aspartate transferase (transminase) to platelet ratio index (APRI) ≤2; OR
2. Documented liver biopsy within 36 months preceding Day 1 showing absence of cirrhosis OR
3. 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 be 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
Clareo Health | 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
