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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00962936
Other study ID # CT-2009-01
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received August 19, 2009
Last updated August 28, 2014
Start date September 2009
Est. completion date January 2013

Study information

Verified date August 2014
Source CureTech Ltd
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 13
Est. completion date January 2013
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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).

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
CT-011
CT-011

Locations

Country Name City State
Israel Hadassah Medical Center Jerusalem

Sponsors (2)

Lead Sponsor Collaborator
CureTech Ltd Teva Pharmaceutical Industries

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess the safety and tolerability of CT-011 in patients with Chronic Hepatitis C due to HCV Genotype I infection 12 months Yes
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