NCT00529321

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2006

Typical duration for phase_1

Geographic Reach
1 country

6 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2007

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 3, 2010

Status Verified

September 1, 2010

Enrollment Period

2.8 years

First QC Date

September 7, 2007

Last Update Submit

September 2, 2010

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

  • Safety (adverse events, vital signs, physical examination, standard laboratory tests)

    regularly

Secondary Outcomes (1)

  • Virology (quantification of HCV-RNA), immunology (cellular-mediated and humoral immune responses)

    regularly

Interventions

MVA-HCV (Immunotherapy)BIOLOGICAL

MVA-HCV

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent obtained and signed;
  • Male or female patients;
  • With chronic hepatitis C (genotype 1) evidenced by HCV positive serology detectable for more than 6 months;
  • Patients with fibrosis status graded F0 or F1 according to the METAVIR grading system; patients with a F2 fibrosis stage could be enrolled on a case-by-case basis after being sure that they have a contraindication to be treated with an IFN-based standard HCV treatment; patients with F3 or F4 fibrosis stage will not be enrolled; this will be assessed either on the liver biopsy performed less than 18 months prior to baseline or on a FibroTest® and a FibroScan® performed within 2 months prior to first TG4040 injection; in case of discordant results, a liver biopsy will be performed prior to TG4040 treatment;;
  • Treatment-naïve patients: patients who have never received IFN-based treatment;
  • Patients must have compensated liver disease, with:
  • No history of ascites, hepatic encephalopathy or bleeding from esophageal varices;
  • Laboratory tests values:
  • Serum alanine aminotransferase (ALT)less then 2 folds the Upper Limit of Normal (ULN);
  • Serum bilirubin and international normalized ratio (INR) values within normal range (except in patients with Gilbert syndrome where serum bilirubin may be as high as 3.0 mg/dL); and
  • Other laboratory parameters of grade 0 or 1 (CTC criteria);
  • For women of child-bearing potential, i.e. with no history of hysterectomy or tubal ligation, a negative pregnancy test at study entry and adequate protection against pregnancy during the conduct of the study and until 3 months after last TG4040 injection.
  • Additionnal cohorts:

You may not qualify if:

  • Patients will be excluded from the study for any of the following reasons:
  • Co-infection with HBV (indicated by the presence of Hepatitis B Surface Antigen (HBsAg) in serum; patients with anti-hepatitis B core antibody response (anti-HBc) will not be excluded) or HIV (anti-HIV antibodies in serum); patients with HIV positive sexual partner (by history) will not be included;
  • Current HCV therapies;
  • Active IV drug or alcohol abuse;
  • Serious, concomitant disorder, including:
  • primary biliary cirrhosis or sclerosing cholangitis;
  • auto-immune disease such as symptomatic cryoglobulinemia, polyarthritis, multiple sclerosis; a broad auto-immune testing will be performed at baseline;
  • proven or suspected immunosuppressive disorder;
  • active systemic infection; if the patient has acute febrile illness ( \> 38°C) on the day of vaccination, it will be delayed by at least one week after complete recovery;
  • Malignancy within the last 5 years; patients with history of squamous cell skin cancer or basal cell skin cancer will be enrolled, unless the history of skin cancer is at the vaccination site;
  • Systemic corticosteroid therapy or other immunosuppressive/immunomodulating drugs (e.g. Cyclosporine) within 2 months prior to first study drug injection; corticosteroid nasal sprays, inhaled steroids for asthma and/or topical steroids are permissible;
  • Participation in another experimental protocol during the study period (last intake of investigational drug within 6 months prior to baseline);
  • Breast-feeding women;
  • Receipt of any inactivated vaccine 14 days prior to vaccination or for the duration of the study; receipt of any live attenuated vaccine within 30 days prior to vaccination or for the duration of the study;
  • Allergy to eggs;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hôpital Henri Mondor

Créteil, 94010, France

Location

Hopital A. Michallon

La Tronche, 38700, France

Location

Hopital de l'Hotel-Dieu

Lyon, 69288, France

Location

Hôpital de l'Hôtel Dieu

Nantes, 44000, France

Location

Hopital Civil

Strasbourg, 67091, France

Location

Hôpital de Brabois

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (1)

  • Habersetzer F, Honnet G, Bain C, Maynard-Muet M, Leroy V, Zarski JP, Feray C, Baumert TF, Bronowicki JP, Doffoel M, Trepo C, Agathon D, Toh ML, Baudin M, Bonnefoy JY, Limacher JM, Inchauspe G. A poxvirus vaccine is safe, induces T-cell responses, and decreases viral load in patients with chronic hepatitis C. Gastroenterology. 2011 Sep;141(3):890-899.e1-4. doi: 10.1053/j.gastro.2011.06.009. Epub 2011 Jun 13.

    PMID: 21699798DERIVED

Related Links

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ImmunomodulationBiological TherapyTherapeutics

Study Officials

  • Christian TREPO, MD

    Hopital de l'Hotel-Dieu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 7, 2007

First Posted

September 14, 2007

Study Start

December 1, 2006

Primary Completion

September 1, 2009

Study Completion

September 1, 2010

Last Updated

September 3, 2010

Record last verified: 2010-09

Locations

FR(6)