Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection
- Registration Number
- NCT00962936
- Lead Sponsor
- CureTech Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 13
Inclusion Criteria
- 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.
Exclusion Criteria
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CT-011 CT-011 -
- Primary Outcome Measures
Name Time Method To assess the safety and tolerability of CT-011 in patients with Chronic Hepatitis C due to HCV Genotype I infection 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hadassah Medical Center
🇮🇱Jerusalem, Israel