NCT00962936

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2009

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

August 29, 2014

Status Verified

August 1, 2014

Enrollment Period

2.1 years

First QC Date

August 19, 2009

Last Update Submit

August 28, 2014

Conditions

Chronic Hepatitis C

Keywords

Chronic Hepatitis CHCV Genotype I infectionLiver disease

Outcome Measures

Primary Outcomes (1)

  • To assess the safety and tolerability of CT-011 in patients with Chronic Hepatitis C due to HCV Genotype I infection

    12 months

Study Arms (1)

CT-011

EXPERIMENTAL
Drug: CT-011

Interventions

CT-011DRUG

CT-011

CT-011

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient is between 18 and 60 years of age, both genders.
  • Biopsy proven infection with Hepatitis C genotype 1.
  • Positive for anti-HCV.
  • Chronically infected for at least 3 months from diagnosis.
  • ECOG performance status ≤ 1.
  • Previous therapy with interferon +/- Ribavirin or Peginterferon +/- Ribavirin or ineligibility for this type of therapy or for liver transplantation.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Hepatitis C, ChronicLiver Diseases

Interventions

pidilizumab

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yaron Ilan, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2009

First Posted

August 20, 2009

Study Start

September 1, 2009

Primary Completion

October 1, 2011

Study Completion

January 1, 2013

Last Updated

August 29, 2014

Record last verified: 2014-08

Locations

IL(1)