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

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00962936
• Other study ID #: CT-2009-01
• 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

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

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