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Clinical Trials/NCT00962936
NCT00962936
Terminated
Phase 1

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

CureTech Ltd1 site in 1 country13 target enrollmentSeptember 2009
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ConditionsChronic Hepatitis C
InterventionsCT-011
DrugsCT-011

Overview

Phase
Phase 1
Intervention
CT-011
Conditions
Chronic Hepatitis C
Sponsor
CureTech Ltd
Enrollment
13
Locations
1
Primary Endpoint
To assess the safety and tolerability of CT-011 in patients with Chronic Hepatitis C due to HCV Genotype I infection
Status
Terminated
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
January 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Patient is between 18 and 60 years of age, both genders.
  • •Biopsy proven infection with Hepatitis C genotype
  • •Positive for anti-HCV.
  • •Chronically infected for at least 3 months from diagnosis.
  • •ECOG performance status ≤
  • •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).

Arms & Interventions

CT-011

Intervention: CT-011

Outcomes

Primary Outcomes

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

Study Sites (1)

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