Status:
TERMINATED
Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection
Lead Sponsor:
CureTech Ltd
Collaborating Sponsors:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00962936
Start Date
September 1 2009
End Date
January 1 2013
Last Update
August 29 2014
Active Locations (1)
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1
Hadassah Medical Center
Jerusalem, Israel, 91120