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

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ClinicalTrials.gov Identifier: NCT00962936
Recruitment Status : Terminated
First Posted : August 20, 2009
Last Update Posted : August 29, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: CT-011 Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2009
Primary Completion Date : October 2011
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: CT-011 Drug: CT-011
CT-011


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: CureTech Ltd
ClinicalTrials.gov Identifier: NCT00962936     History of Changes
Other Study ID Numbers: CT-2009-01
First Posted: August 20, 2009    Key Record Dates
Last Update Posted: August 29, 2014
Last Verified: August 2014

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

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