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

CureTech

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Chronic Hepatitis C

Treatments: Drug: CT-011

Study type: Interventional

Funder types: Industry

Identifiers

NCT00962936

CT-2009-01

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

CT-011

Experimental group

Treatment:

Drug: CT-011