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

Overview

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.

Full Title of Study: “Phase I/II Study to Evaluate the Safety and Tolerability of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2011

Interventions

  • Drug: CT-011
    • CT-011

Arms, Groups and Cohorts

  • Experimental: CT-011

Clinical Trial Outcome Measures

Primary Measures

  • To assess the safety and tolerability of CT-011 in patients with Chronic Hepatitis C due to HCV Genotype I infection
    • Time Frame: 12 months

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • CureTech Ltd
  • Collaborator
    • Teva Branded Pharmaceutical Products R&D, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yaron Ilan, MD, Principal Investigator, Hadassah Medical Organization

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