NCT00148863

Brief Summary

Viral hepatitis C is treated with peg-interferon alpha 2a/2b and ribavirin. There is no treatment recommended for non responders patients. This study will evaluate the efficacy, after a second treatment with peg-interferon alpha 2a and ribavirin for 12 Weeks of the addition of interferon gamma in non responders patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2004

Typical duration for phase_2

Geographic Reach
1 country

2 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

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

August 30, 2007

Status Verified

August 1, 2007

First QC Date

September 7, 2005

Last Update Submit

August 29, 2007

Conditions

Hepatitis C, Chronic

Keywords

Hepatitis C, ChronicInterferon Alfa-2aRibavirinInterferon-gamma, Recombinant

Outcome Measures

Primary Outcomes (1)

  • Virological response as defined by an HCV RNA measure non detectable at W28 with qualitative PCR (centralized measure)

Secondary Outcomes (5)

  • Virological response at W72

  • Biochemical response at W72 (ALT below normal value)

  • Quality of life

  • Immunologic response (CD4 and CD8 HCV specific)

  • Safety

Interventions

Peg-interferon alpha 2a (drug)DRUG
Ribavirin (drug)DRUG
Interferon gamma (drug)DRUG

Eligibility Criteria

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

You may qualify if:

  • Positive anti-HCV antibodies
  • Positive HCV RNA (quantitative method)
  • Previous treatment with Peg-interferon alpha 2b 1.0 to 1.5 micro g/kg (during at least 12 weeks) with ribavirin (at least 800 mg/day during at least 12 weeks),stopped since at least 3 months
  • Without lower dosage during previous treatment
  • Non responder to the previous treatment with Peg-interferon alpha 2b and ribavirin, with detectable HCV RNA at W24 or decrease of less than 2 log10 copies/ml at W12 or decrease greater than 2 log10 but detectable HCV RNA
  • Metavir over F2 on the most recent biopsy
  • ALT increase over normal value twice during last 6 months

You may not qualify if:

  • HIV infection
  • Psychiatric pathology
  • Alcool consummation
  • Cirrhosis
  • Pregnancy or plan of pregnancy
  • Breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hopital Haut Leveque Service d'Hepato-Gastro-Enterologie

Pessac, 33604, France

Location

Hôpital du Haut-Levêque

Pessac, 33604, France

Location

Related Publications (1)

  • Couzigou P, Perusat S, Bourliere M, Trimoulet P, Poynard T, Leroy V, Marcellin P, Foucher J, Bronowicki JP, Chene G; ANRS HC16 GAMMATRI Trial Group. Interferon-gamma with peginterferon alpha-2a and ribavirin in nonresponder patients with chronic hepatitis C (ANRS HC16 GAMMATRI). J Gastroenterol Hepatol. 2013 Feb;28(2):329-34. doi: 10.1111/jgh.12060.

    PMID: 23190183DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Pharmaceutical PreparationsRibavirinInterferon-gamma

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)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsMacrophage-Activating FactorsLymphokinesProteinsBiological Factors

Study Officials

  • Patrice Couzigou, MD, PhD

    Hôpital du Haut-Lévêque, Pessac, France

    PRINCIPAL INVESTIGATOR

  • Geneviève Chêne, MD, PhD

    INSERM U593, Bordeaux, France

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 8, 2005

Study Start

June 1, 2004

Study Completion

August 1, 2007

Last Updated

August 30, 2007

Record last verified: 2007-08

Locations

FR(2)