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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

August 19, 2009
October 22, 2012
September 2009
October 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00962936 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis C
Drug: CT-011
CT-011
Experimental: CT-011
Intervention: Drug: CT-011
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
13
January 2013
October 2011   (final data collection date for primary outcome measure)

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).
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00962936
CT-2009-01
No
CureTech Ltd
CureTech Ltd
Teva Pharmaceutical Industries
Principal Investigator: Yaron Ilan, MD Hadassah Medical Center
CureTech Ltd
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP