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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study in Healthy Volunteers to Evaluate a Human Monoclonal Antibody Against Hepatitis C

NCT00952263

Healthy

COMPLETED PHASE1

A Study of MDX-1106 to Treat Patients With Hepatitis C Infection

NCT00703469

Hepatitis C

COMPLETED PHASE1

A Phase 1/2 Study of CF102 in Patients With Chronic Hepatitis C Genotype 1

NCT00790673

Chronic Hepatitis C

COMPLETED PHASE1/PHASE2

Study of XTL6865 in Patients With Chronic Hepatitis C Virus Infection

NCT00300807

Hepatitis C

UNKNOWN PHASE1

Oral Administration of Anti-CD3 Monoclonal Antibody in Non-responder Genotype-I Chronic Hepatitis C Subjects

NCT01459419

Chronic Hepatitis C

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Hepatitis C

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CT-011

Group Type EXPERIMENTAL

CT-011

Intervention Type DRUG

CT-011

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CT-011

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No