Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection

• Status: Terminated
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CureTech Ltd
• Collaborators: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Pharmaceutical Industries
• Treatments: Antibodies; Antibodies, Monoclonal; Pidilizumab

Criteria

Inclusion Criteria:

1. Patient is between 18 and 60 years of age, both genders.

2. Biopsy proven infection with Hepatitis C genotype 1.

3. Positive for anti-HCV.

4. Chronically infected for at least 3 months from diagnosis.

5. ECOG performance status ≤ 1.

6. Previous therapy with interferon +/- Ribavirin or Peginterferon +/- Ribavirin or ineligibility for this type of therapy or for liver transplantation.

Exclusion Criteria:

1. Patients who received any type of anti viral treatment during the 3 months prior to enrollment.

2. Any history or active malignancy.

3. History of major organ transplantation with an existing functional graft.

4. Patients who received any systemic concurrent therapy within the last 4 weeks.

5. Patients progressing to acute liver failure (ALF).