Interest of Ribavirin in the Maintenance Treatment of Liver Fibrosis Using Low Dose Pegylated Interferon alpha2b in Patients With Chronic Hepatitis C Non Responders to Previous Antiviral Therapy.
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by French National Agency for Research on AIDS and Viral Hepatitis.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators:
Schering-Plough
Rennes University Hospital
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00323804
First received: May 9, 2006
Last updated: March 18, 2008
Last verified: March 2008
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Purpose
Patients with chronic hepatitis C who did not respond to previous antiviral treatment develop liver fibrosis leading to cirrhosis. Maintenance low dose pegylated interferon therapy of fibrosis is currently under investigation in large multicenter trials. The aim of our study is to assess if peginterferon alpha2b plus ribavirin is more efficient than peginterferon alpha2b alone. 454 patients will be randomized between the 2 arms and the efficacy will be assessed, after 3 years of treatment, on Metavir liver fibrosis score improvement.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C, Chronic Liver Fibrosis |
Drug: Peginterferon alpha-2b + ribavirin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Randomized, Double-Blind, Placebo-Controlled Multicenter Study Evaluating the Interest of a Long-Term (3 Years) Treatment With Peginterferon Alfa-2b and Ribavirin on Liver Fibrosis in Non-Responder Chronic Hepatitis C Patients. |
Resource links provided by NLM:
Genetics Home Reference related topics:
North American Indian childhood cirrhosis
U.S. FDA Resources
Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:
Primary Outcome Measures:
- Rate of patients with at least a one point improvement in Metavir fibrosis score between the inclusion and the end-of-study liver biopsies.
Secondary Outcome Measures:
- Distribution of the Metavir scoring on the end-of-study biopsy
- Distribution of the Chevallier fibrosis score
- Evolution of the area of fibrosis between the inclusion and the end-of -study biopsies
- Fibrosis serum markers
- Liver elasticity before and after treatment
- Safety of treatment and quality of life
- Frequency of occurrence of hepatic complications and/or liver transplantations
- Evolution of the hepatitis C viral load
- Rate of patients with loss of detectable hepatitis C virus RNA
| Estimated Enrollment: | 454 |
| Study Start Date: | May 2006 |
Up to 45% of patients with chronic hepatitis C do not respond to pegylated interferon/ribavirin combination therapy. These patients are prone to develop liver fibrosis leading to cirrhosis and its complications. Interferon has proven to be efficient in liver fibrosis treatment even in case of virological non response. Maintenance low dose pegylated interferon therapy is currently under investigation in large multicenter trials. The aim of our study is to assess wether peginterferon alpha 2 b (0.5 µg/kg/week) plus ribavirin (800-1200 mg according to body weight) is more efficient than peginterferon alpha 2 b alone in a long term 3 years treatment of liver fibrosis. 454 patients, non responders (VHC RNA positive after 24 weeks of treatment or absence of ≥ 2 log HCV RNA drop after 12 weeks of treatment) to a previous peginterferon/ribavirin antiviral treatment will be randomized between the 2 arms, with a double-blind masking of ribavirin. The efficacy will be assessed on Metavir liver fibrosis score improvement between pre and post therapeutic liver biopsy.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adults over 18
- With a hepatitis C virus infection (HCV RNA and anti-HCV antibodies in serum)
- Not responders to a previous antiviral treatment using the interferon plus ribavirin combination
- With a wash-out of treatment for at least 6 months
- With an active chronic hepatitis C and a Metavir fibrosis score ≥ 2
- Serum ALT levels > upper limit of the laboratory on two occasions within 6 months before inclusion
- Accepting to undergo a liver biopsy at the end of the study
- Negative pregnancy test for women
- With a social security cover
- Written informed consent
Exclusion Criteria:
- History of hepatic complications
- History of transplantation
- History of severe seizures
- History of severe psychiatric disorders
- Drug addiction within the last 12 months
- Associated condition susceptible to be responsible for liver fibrosis
- Hepatocellular carcinoma
- Cardiovascular disease unstable under treatment
- Uncontrolled diabetes
- Retinopathy
- Thyroid disease unstable under treatment
- Epilepsy and/or central nervous system functional disorders
- Autoimmune disease
- Regular alcohol consumption
- Pregnancy, breast-feeding or absence of contraception
- Haemoglobin <12 g/dl
- platelets <50000/mm3
- Neutrophils < 1200/ mm3
- Severe hepatocellular failure (prothrombin index lower than 60%)
- Renal failure (creatinine clearance lower than 50 mL/Mn)
- Associated immunosuppressive drugs, corticosteroids, antiviral drugs (other than study ones)
- Treatment with drugs likely to have an effect on fibrosis
- Anticonvulsants
- Inability to tolerate interferon
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323804
Contacts
| Contact: Dominique Guyader, MD | 33-2-9928-4297 | Dominique.Guyader@univ-rennes1.fr |
| Contact: Eric Bellissant, MD, PhD | 33-2-9928-9200 | eric.bellissant@chu-rennes.fr |
Locations
| France | |
| Service d'Hépatogastroentérologie et d'endoscopie digestive - CH du Pays d'Aix | Recruiting |
| Aix en Provence, France, 13616 | |
| Contact: Claire Wartelle, MD 33-4-4233-5064 | |
| Principal Investigator: Claire Wartelle, MD | |
| Sub-Investigator: Magali Picon-Coste, MD | |
| Service d'Hépatogastroentérologie - Hôpital Nord | Recruiting |
| Amiens, France, 80054 | |
| Contact: Dominique Capron, MD 33-3-2266-8207 capron.dominique@chu-amiens.fr | |
| Principal Investigator: Dominique Capron, MD | |
| Sub-Investigator: Eric Nguyen-Khac, MD | |
| Service d'Hépatologie - Gastroentérologie - Cancérologie digestive - CHU Angers | Recruiting |
| Angers, France, 49100 | |
| Contact: Paul Calès, MD 33-2-4135-5522 Paul.Cales@univ-angers.fr | |
| Principal Investigator: Paul Calès, MD | |
| Sub-Investigator: Isabelle Hubert-Fouchard, MD | |
| Service d'Hépatogastroentérologie - CH Victor Dupouy | Recruiting |
| Argenteuil, France, 95100 | |
| Contact: Philippe Renard, MD 33-1-3423-1674 philippe.renard@ch-argenteuil.fr | |
| Principal Investigator: Philippe Renard, MD | |
| Sub-Investigator: Daniel Salaun, MD | |
| Service d'Hépatogastroentérologie - Hôpital Jean Minjoz | Recruiting |
| Besançon, France, 25000 | |
| Contact: Jean-Philippe Miguet, MD 33-3-8166-8421 jean-philippe.miguet@ufc-chu.univ-fcomt | |
| Principal Investigator: Jean-Philippe Miguet, MD | |
| Sub-Investigator: Claire Valemmens, MD | |
| Service d'Hépatogastroentérologie - Hôpital Avicenne | Recruiting |
| Bobigny, France, 93009 | |
| Contact: Dominique Roulot, MD 33-1-4895-5373 dominique.roulot@avc.aphp.fr | |
| Principal Investigator: Dominique Roulot, MD | |
| Service d' Hépatogastroentérologie - Hôpital Jean Verdier | Recruiting |
| Bondy, France, 93143 | |
| Contact: Michel Beaugrand, MD 33-1-4802-6280 michel.beaugrand@jvr.aphp.fr | |
| Principal Investigator: Michel Beaugrand, MD | |
| Sub-Investigator: Véronique Grando, MD | |
| Cabinet Médical | Recruiting |
| Bourgoin-Jallieu, France, 38300 | |
| Contact: Thierry Fontanges, MD 33-4-7428-0844 fontanges@aol.com | |
| Principal Investigator: Thierry Fontanges, MD | |
| Service d'Hépatogastroentérologie - Hôpital de la Cavale Blanche | Recruiting |
| Brest, France, 29200 | |
| Contact: Jean-Baptiste Nousbaum, MD 33-2-9834-7148 jean-baptiste.nousbaum@chu-brest.fr | |
| Principal Investigator: Jean-Baptiste Nousbaum, MD | |
| Sub-Investigator: Florence Tanné, MD | |
| Service d'Hépatologie - Gastroentérologie - Nutrition -Hôpital de la Côte de Nacre | Recruiting |
| Caen, France, 14000 | |
| Contact: Thong Dao, MD 33-2-3106-4544 dao-t@chu-caen.fr | |
| Principal Investigator: Thong Dao, MD | |
| Sub-Investigator: Samouh Elfadel, MD | |
| Service d'Hépatogastroentérologie - CH de Chateauroux | Recruiting |
| Chateauroux, France, 36000 | |
| Contact: Thierry Sapey, MD 33-2-5429-6002 thierrysapey@hotmail.com | |
| Principal Investigator: Thierry Sapey, MD | |
| Sub-Investigator: Denis Kabissa Imed, MD | |
| Service d'Hépatogastroentérologie - Hotel Dieu | Recruiting |
| Clermont-Ferrand, France, 63058 | |
| Contact: Armand Abergel, MD 33-4-7375-0504 aabergel@chu-clermontferrand.fr | |
| Principal Investigator: Armand Abergel, MD | |
| Sub-Investigator: Karine Randl, MD | |
| Service d'Hépatogastroentérologie - Hôpital Beaujon | Recruiting |
| Clichy, France, 92110 | |
| Contact: Patrick Marcellin, MD 33-1-4087-5522 patrick.marcellin@bjn.aphp.fr | |
| Principal Investigator: Patrick Marcellin, MD | |
| Sub-Investigator: Nathalie Boyer, MD | |
| Service d'Hépatogastroentérologie - CH Sud Francilien | Recruiting |
| Corbeil-Essonnes, France, 91100 | |
| Contact: Jacques Denis, MD 33-1-6087-7834 jacques.denis@ch-sud-francilien.fr | |
| Principal Investigator: Jacques Denis, MD | |
| Sub-Investigator: Bénédicte Lambaré, MD | |
| Service d'Hépatogastroentérologie - Hôpital du Bocage | Recruiting |
| Dijon, France, 21079 | |
| Contact: Patrick Hillon, MD 33-3-8029-3750 patrick.hillon@chu-dijon.fr | |
| Principal Investigator: Patrick Hillon, MD | |
| Sub-Investigator: Anne Minello, MD | |
| Service d'Hépatogastroentérologie - CH La Roche sur Yon | Recruiting |
| La Roche sur Yon, France, 85925 | |
| Contact: Matthieu Schnée, MD 33-2-5144-6168 matthieu.schnée@chd-vendee.fr | |
| Principal Investigator: Matthieu Schnée, MD | |
| Sub-Investigator: Jean-Pierre Lafargue, MD | |
| Service des Maladies du Foie et de l'appareil Digestif - Hôpital de Bicêtre | Recruiting |
| Le Kremlin-Bicetre, France, 94275 | |
| Contact: Rita Bou Farah, MD 33-1-4521-3724 | |
| Principal Investigator: Rita Bou Farah, MD | |
| Sub-Investigator: Catherine Buffet, MD | |
| Département d'Hépatogastroentérologie - CH Le Mans | Recruiting |
| Le Mans, France, 72037 | |
| Contact: Christophe Pilette, MD 33-2-4343-2752 cpilette@ch-lemans.fr | |
| Principal Investigator: Christophe Pilette, MD | |
| Sub-Investigator: Alain Blanchi, MD | |
| Service d'Hépatogastroentérologie - CHRU - Hôpital Claude Huriez | Recruiting |
| Lille, France, 59000 | |
| Contact: Philippe Mathurin, MD 33-3-2044-5343 p-mathurin@chru-lille.fr | |
| Principal Investigator: Philippe Mathurin, MD | |
| Sub-Investigator: Valérie Canva, MD | |
| Unité de Médecine Interne A - Hôpital Dupuytren | Recruiting |
| Limoges, France, 87042 | |
| Contact: Véronique Loustaud-Ratti, MD 33-5-5505-6684 veronique.loustaud-ratti@unilim.fr | |
| Principal Investigator: Véronique Loustaud-Ratti, MD | |
| Sub-Investigator: Marilyne Debette Gratien, MD | |
| Service d'Hépatogastroentérologie - Hotel Dieu | Recruiting |
| Lyon, France, 69288 | |
| Contact: Christian Trépo, MD 33-4-7241-3089 christian.trépo@chu-lyon.fr | |
| Principal Investigator: Christian Trépo, MD | |
| Sub-Investigator: Fabien Zoulim, MD | |
| Service d'Hépatogastroentérologie - Hôpital Saint Joseph | Recruiting |
| Marseille, France, 13008 | |
| Contact: Marc Bourlière, MD 33-4-9180-6608 mbourliere@hopital-saint-joseph.fr | |
| Principal Investigator: Marc Bourlière, MD | |
| Sub-Investigator: Valérie Oules, MD | |
| Service d'Hépatogastroentérologie - CH Montauban | Recruiting |
| Montauban, France, 82000 | |
| Contact: Jean-Louis Payen, MD 33-5-6392-8119 jl.payen@ch-montauban.fr | |
| Principal Investigator: Jean-Louis Payen, MD | |
| Service d'Hépatogastroentérologie - CH Montélimar | Recruiting |
| Montelimar, France, 26200 | |
| Contact: Bernard Nalet, MD 33-4-7553-4058 bernard.nalet@ch-montélimar.fr | |
| Principal Investigator: Bernard Nalet, MD | |
| Service d'Hépatogastroentérologie - Hôpital Saint Eloi | Recruiting |
| Montpellier, France, 34295 | |
| Contact: Dominique Larrey, MD 33-4-6733-7062 dom-larrey@chu-montpellier.fr | |
| Principal Investigator: Dominique Larrey, MD | |
| Sub-Investigator: Georges Pageaud, MD | |
| Service d'Hépatogastroentérologie - Hôpital Nord Laennec | Recruiting |
| Nantes, France, 44093 | |
| Contact: Jérôme Gournay, MD 33-2-4016-5683 jérôme.gournay@chu-nantes.fr | |
| Principal Investigator: Jérôme Gournay, MD | |
| Sub-Investigator: Karine Richou, MD | |
| Service d'Hépatogastroentérologie - Hôpital de la Source | Recruiting |
| Orléans, France, 45067 | |
| Contact: Xavier Causse, MD 33-2-3851-4245 xavier.causse@chr-orleans.fr | |
| Principal Investigator: Xavier Causse, MD | |
| Sub-Investigator: Nafa Si Ahmed, MD | |
| Service d'Hépatogastroentérologie - Hôpital Necker | Recruiting |
| Paris, France, 75015 | |
| Contact: Stanislas Pol, MD 33-1-4449-4438 stanislas.pol@nck.aphp.fr | |
| Principal Investigator: Stanislas Pol, MD | |
| Sub-Investigator: Hélène Fontaine, MD | |
| Service d'Hépatogastroentérologie - Hôpital La Pitié Salpétrière | Recruiting |
| Paris, France, 75013 | |
| Contact: Thierry Poynard, MD 33-1-4216-1002 tpoynard@teaser.fr | |
| Principal Investigator: Thierry Poynard, MD | |
| Sub-Investigator: Pascal Lebray, MD | |
| Service d'Hépatogastroentérologie - Hôpital Tenon | Recruiting |
| Paris, France, 75020 | |
| Contact: Jean-Didier Grange, MD 33-1-5601-6404 jean-didier.grange@tnn.aphp.fr | |
| Principal Investigator: Jean-Didier Grange, MD | |
| Sub-Investigator: Xavier Amiot, MD | |
| Service d'Hépatogastroentérologie - Hôpital Cochin | Recruiting |
| Paris, France, 75014 | |
| Contact: Philippe Sogni, MD 33-1-5841-1952 philippe.sogni@cch.aphp.fr | |
| Principal Investigator: Philippe Sogni, MD | |
| Sub-Investigator: Philippe Podevin, MD | |
| Service d'Hépatogastroentérologie et d'Assistance nutritive - Hôpital Haut-Lévêque | Recruiting |
| Pessac, France, 33604 | |
| Contact: Victor De Ledinghen, MD 33-5-5765-6439 victor.deledinghen@chu-bordeaux.fr | |
| Principal Investigator: Victor De Ledinghen, MD | |
| Sub-Investigator: Juliette Foucher, MD | |
| Service d'Hépatogastroentérologie - Hôpital Pontchaillou | Recruiting |
| Rennes, France, 35033 | |
| Contact: Dominique Guyader, MD 33-2-9928-4297 Dominique.Guyader@univ-rennes1.fr | |
| Principal Investigator: Dominique Guyader, MD | |
| Sub-Investigator: Yves Deugnier, MD | |
| Service d'Hépatogastroentérologie - CHU Rouen | Recruiting |
| Rouen, France, 76031 | |
| Contact: Ghassan Riachi, MD 33-2-3288-8101 ghassan.riachi@chu-rouen.fr | |
| Principal Investigator: Ghassan Riachi, MD | |
| Sub-Investigator: Odile Goria, MD | |
| Service d'Hépatogastroentérologie - CH Saint Dizier | Recruiting |
| Saint Dizier, France, 52115 | |
| Contact: Pascal Melin, MD 33-3-2556-8558 pascal.melin@wanadoo.fr | |
| Principal Investigator: Pascal Melin, MD | |
| Sub-Investigator: Schoeny, MD | |
| Service d'Hépatogastroentérologie, Clinique médicale B - Hôpital Civil | Recruiting |
| Strasbourg, France, 67000 | |
| Contact: Michel Doffoel, MD 33-3-8811-5244 michel.doffoel@chru-strasbourg.fr | |
| Principal Investigator: Michel Doeffel, MD | |
| Sub-Investigator: François Habersezter, MD | |
| Service d'Hépatogastroentérologie - Hôpital Purpan | Recruiting |
| Toulouse, France, 31059 | |
| Contact: Jean-Pierre Vinel, MD 33-5-6177-2114 vinel.jp@chu-toulouse.fr | |
| Contact: Laurent Alric, MD alric.l@chu-toulouse.fr | |
| Principal Investigator: Jean-Pierre Vinel, MD | |
| Sub-Investigator: Laurent Alric, MD | |
| Sub-Investigator: Sophie Metivier, MD | |
| Service d'Hépatogastroentérologie - Hôpital Trousseau | Recruiting |
| Tours, France, 37044 | |
| Contact: Louis d'Alteroche, MD 33-2-4747-5965 | |
| Principal Investigator: Louis d'Alteroche, MD | |
| Sub-Investigator: Yannick Bacq, MD | |
| Service d'Hépatogastroentérologie - Hôpital Brabois | Recruiting |
| Vandoeuvre les Nancy, France, 54500 | |
| Contact: Jean-Pierre Bronowicki, MD 33-3-8315-3359 jp.bronowicki@chu-nancy.fr | |
| Principal Investigator: Jean-Pierre Bronowicki, MD | |
| Sub-Investigator: Laurence Chone, MD | |
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Schering-Plough
Rennes University Hospital
Investigators
| Principal Investigator: | Dominique Guyader, MD | CHU Rennes |
| Study Chair: | Eric Bellissant, MD, PhD | CHU Rennes |
More Information
No publications provided
| Responsible Party: | Nadia Squalli/regulatory affairs, ANRS |
| ClinicalTrials.gov Identifier: | NCT00323804 History of Changes |
| Other Study ID Numbers: | ANRS HC15 NRfi, AFSSAPS 060246-34, CIC0203/020, EUDRACT 2005-002937-11 |
| Study First Received: | May 9, 2006 |
| Last Updated: | March 18, 2008 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
|
Maintenance therapy Non-responder patients Ribavirin/peginterferon combination therapy Hepatitis C, Chronic |
Additional relevant MeSH terms:
|
Fibrosis Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Liver Cirrhosis Hepatitis C, Chronic Pathologic Processes Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Flaviviridae Infections Ribavirin Peginterferon alfa-2b Interferon-alpha Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013