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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Teva Pharmaceutical Industries
Information provided by (Responsible Party):
CureTech Ltd
ClinicalTrials.gov Identifier:
NCT00962936
First received: August 19, 2009
Last updated: October 22, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
 Drug: CT-011
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CureTech Ltd:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: September 2009
Estimated Study Completion Date: January 2013
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CT-011 Drug: CT-011
CT-011

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962936

Locations
Israel
Hadassah Medical Center
Jerusalem, Israel, 91120
Sponsors and Collaborators
CureTech Ltd
Teva Pharmaceutical Industries
Investigators
Principal Investigator: Yaron Ilan, MD Hadassah Medical Center
  More Information

No publications provided

Responsible Party: CureTech Ltd
ClinicalTrials.gov Identifier: NCT00962936     History of Changes
Other Study ID Numbers: CT-2009-01
Study First Received: August 19, 2009
Last Updated: October 22, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by CureTech Ltd:
Chronic Hepatitis C
HCV Genotype I infection
Liver disease

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013