MedTrace Logo

Immunotherapy With TG4040 in Treatment-naïve Patients Chronically Infected With Hepatitis C Virus

NCT00529321 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2010-09-03

No results posted yet for this study

Summary

The primary objective is to determine the safety of sub-cutaneous (SC) injections of TG4040 in non-cirrhotic, treatment-naïve patients chronically infected with HCV (genotype 1).

Patients will be sequentially treated at an escalting dose of TG4040. All patients will be followed up to at least 6 months after his/her first injection. In addition, all patients treated at the highest dose will receive a TG4040 boost injection 6 months after the first injection, and will be followed up during an additional 6-month period.

Conditions

  • Hepatitis C, Chronic

Interventions

BIOLOGICAL

MVA-HCV (Immunotherapy)

MVA-HCV

Sponsors & Collaborators

  • Transgene

    lead INDUSTRY

Principal Investigators

  • Christian TREPO, MD · Hopital de l'Hotel-Dieu

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2009-09-30
Completion
2010-09-30

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00529321 on ClinicalTrials.gov