Back to resultsSafety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection
Primary Purpose
Chronic Hepatitis C
Status
Terminated
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
CT-011
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Chronic Hepatitis C, HCV Genotype I infection, Liver disease
Eligibility Criteria
Inclusion Criteria:
- Patient is between 18 and 60 years of age, both genders.
- Biopsy proven infection with Hepatitis C genotype 1.
- Positive for anti-HCV.
- Chronically infected for at least 3 months from diagnosis.
- ECOG performance status ≤ 1.
- Previous therapy with interferon +/- Ribavirin or Peginterferon +/- Ribavirin or ineligibility for this type of therapy or for liver transplantation.
Exclusion Criteria:
- Patients who received any type of anti viral treatment during the 3 months prior to enrollment.
- Any history or active malignancy.
- History of major organ transplantation with an existing functional graft.
- Patients who received any systemic concurrent therapy within the last 4 weeks.
- Patients progressing to acute liver failure (ALF).
Sites / Locations
- Hadassah Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CT-011
Arm Description
Outcomes
Primary Outcome Measures
To assess the safety and tolerability of CT-011 in patients with Chronic Hepatitis C due to HCV Genotype I infection
Secondary Outcome Measures
Full Information
NCT ID
NCT00962936
First Posted
August 19, 2009
Last Updated
August 28, 2014
Sponsor
CureTech Ltd
Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00962936
Brief Title
Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection
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 Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Study Start Date
September 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CureTech Ltd
Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Chronic Hepatitis C, HCV Genotype I infection, Liver disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CT-011
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CT-011
Intervention Description
CT-011
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is between 18 and 60 years of age, both genders.
Biopsy proven infection with Hepatitis C genotype 1.
Positive for anti-HCV.
Chronically infected for at least 3 months from diagnosis.
ECOG performance status ≤ 1.
Previous therapy with interferon +/- Ribavirin or Peginterferon +/- Ribavirin or ineligibility for this type of therapy or for liver transplantation.
Exclusion Criteria:
Patients who received any type of anti viral treatment during the 3 months prior to enrollment.
Any history or active malignancy.
History of major organ transplantation with an existing functional graft.
Patients who received any systemic concurrent therapy within the last 4 weeks.
Patients progressing to acute liver failure (ALF).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaron Ilan, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection
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