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.
NCT ID: NCT00323804
Last Updated: 2014-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
372 participants
INTERVENTIONAL
2006-05-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Randomised PegIFN alfa 2b + ribavirin (RBV) arm
Combination of ribavirin capsules 200 mg, weight-based daily dose ( \<75 kg : 1000 mg ; ≥ 75 kg : 1200 mg), and low-dose PegIFN alfa 2b by subcutaneous injection 0.5 μg / kg / week, from day 0 to M36
Peginterferon alfa-2b
PegIFN alfa 2b in addition to ribavirin or ribavirin-placebo, from day 0 to M36
Ribavirin
Ribavirin in addition to PegIFN alfa 2b, from day 0 to M36
Randomised PegIFN alfa 2b + ribavirin-placebo arm
Combination of ribavirin-placebo capsules 200 mg, weight-based daily dose ( \<75 kg : 1000 mg ; ≥ 75 kg : 1200 mg), and low-dose PegIFN alfa 2b by subcutaneous injection 0.5 μg / kg / week, from day 0 to M36
Peginterferon alfa-2b
PegIFN alfa 2b in addition to ribavirin or ribavirin-placebo, from day 0 to M36
Ribavirin-Placebo
Ribavirin-placebo in addition to PegIFN alfa 2b, from day 0 to M36
Interventions
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Peginterferon alfa-2b
PegIFN alfa 2b in addition to ribavirin or ribavirin-placebo, from day 0 to M36
Ribavirin
Ribavirin in addition to PegIFN alfa 2b, from day 0 to M36
Ribavirin-Placebo
Ribavirin-placebo in addition to PegIFN alfa 2b, from day 0 to M36
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Rennes University Hospital
OTHER
ANRS, Emerging Infectious Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Dominique Guyader, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CHU Rennes
Eric Bellissant, MD, PhD
Role: STUDY_CHAIR
CHU Rennes
Locations
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CHU Brugmann
Brussels, , Belgium
Hôpital Bracops
Brussels, , Belgium
Hôpital Erasme
Brussels, , Belgium
Hôpital de Jolimont
La Louvière, , Belgium
CHU Sart Tilman
Liège, , Belgium
Service d'Hépatogastroentérologie et d'endoscopie digestive - CH du Pays d'Aix
Aix-en-Provence, , France
Hôpital Nord
Amiens, , France
Service d'Hépatogastroentérologie - Hôpital Nord
Amiens, , France
Service d'Hépatologie - Gastroentérologie - Cancérologie digestive - CHU Angers
Angers, , France
Centre Hospitalier Victor Dupouy
Argenteuil, , France
Service d'Hépatogastroentérologie - Hôpital Avicenne
Bobigny, , France
Service d' Hépatogastroentérologie - Hôpital Jean Verdier
Bondy, , France
Service d'Hépatogastroentérologie et d'Assistance nutritive - Hôpital Haut-Lévêque
Bordeaux Pessac, , France
CH Pierre OUDOT
Bourgoin, , France
Service d'Hépatogastroentérologie - Hôpital de la Cavale Blanche
Brest, , France
Service d'Hépatologie - Gastroentérologie - Nutrition -Hôpital de la Côte de Nacre
Caen, , France
Centre Hospitalier
Châteauroux, , France
Service d'Hépatogastroentérologie - CHU d'ESTAING
Clermont-Ferrand, , France
Service d'Hépatogastroentérologie - Hôpital Beaujon
Clichy, , France
Service d'Hépatogastroentérologie - CH Sud Francilien
Corbeil-Essonnes, , France
Service d'Hépatogastroentérologie - Hôpital du Bocage
Dijon, , France
Hôpital Nord
Grenoble, , France
Service d'Hépatogastroentérologie - CH La Roche sur Yon
La Roche-sur-Yon, , France
Service des Maladies du Foie et de l'appareil Digestif - Hôpital de Bicêtre
Le Kremlin-Bicêtre, , France
Département d'Hépatogastroentérologie - CH Le Mans
Le Mans, , France
Service d'Hépatogastroentérologie - CHRU - Hôpital Claude Huriez
Lille, , France
Service d'Hépatogastroentérologie - Hotel de la Croix Rousse
Lyon, , France
Service d'Hépatogastroentérologie - Hôpital Saint Joseph
Marseille, , France
Service d'Hépatogastroentérologie - CH Montauban
Montauban, , France
Service d'Hépatogastroentérologie - CH Montélimar
Montélimar, , France
Service d'Hépatogastroentérologie - Hôpital Saint Eloi
Montpellier, , France
Service d'Hépatogastroentérologie - Hôtel Dieu
Nantes, , France
Hôpital de l'Archet
Nice, , France
Service d'Hépatogastroentérologie - Hôpital de la Source
Orléans, , France
Service d'Hépatogastroentérologie - Hôpital La Pitié Salpétrière
Paris, , France
Service d'Hépatogastroentérologie - Hôpital Tenon
Paris, , France
Service d'Hépatogastroentérologie - Hôpital Pontchaillou
Rennes, , France
Service d'Hépatogastroentérologie - CHU Rouen
Rouen, , France
Centre Hospitalier
Saint-Quentin, , France
Service d'Hépatogastroentérologie, Clinique médicale B - Hôpital Civil
Strasbourg, , France
Hôpital Purpan
Toulouse, , France
Service d'Hépatogastroentérologie - Hôpital Purpan
Toulouse, , France
Service d'Hépatogastroentérologie - Hôpital Trousseau
Tours, , France
Service d'Hépatogastroentérologie - Hôpital Brabois
Vandœuvre-lès-Nancy, , France
Hôpita Paul Brousse
Villejuif, , France
Countries
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Other Identifiers
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2005-002937-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ANRS HC15 NRfi
Identifier Type: -
Identifier Source: org_study_id
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