Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection
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This study aims to evaluate whether an investigational monoclonal antibody, CT-011, is safe to give and if it helps patients with hepatitis C virus (HCV). Monoclonal antibodies are a type of drug that is typically given by infusion into a vein (intravenously). Results of this trial will help doctors obtain additional information with regard to the safety and efficacy of CT-011 as a potential treatment for HCV.
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Ages Eligible for Study:
18 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patient is between 18 and 60 years of age, both genders.
Biopsy proven infection with Hepatitis C genotype 1.
Positive for anti-HCV.
Chronically infected for at least 3 months from diagnosis.
ECOG performance status ≤ 1.
Previous therapy with interferon +/- Ribavirin or Peginterferon +/- Ribavirin or ineligibility for this type of therapy or for liver transplantation.
Patients who received any type of anti viral treatment during the 3 months prior to enrollment.
Any history or active malignancy.
History of major organ transplantation with an existing functional graft.
Patients who received any systemic concurrent therapy within the last 4 weeks.
Patients progressing to acute liver failure (ALF).