- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00274495
Assessing the Efficacy and Safety of Rosiglitazone Added to Standard Therapy for Hepatitis C Genotype 1 With Fatty Liver
Randomized Placebo-Control Pilot Study Evaluating the Efficacy and Safety of Rosiglitazone Combined With Pegylated Interferon Plus Ribavirin Versus Pegylated Interferon Plus Ribavirin Alone in Genotype 1 Hepatitis C With Steatosis
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Eligible thirty subjects will be randomized in a double blinded fashion to either Rosiglitazone 4mg pills twice a day versus placebo for six weeks. Then after this six week period, both groups will be treated for 48 weeks of standard therapy for hepatitis C consisting of Pegasys 180mcq weekly injections with Ribavirin 1,000mg-1,200mg daily depending if the subject weights less than 75 kg will then receive the lower dosage. In addition, the subjects will be continued on Rosiglitazone or placebo for the 48 weeks.
The subjects will be monitored for side-effects by history taking and blood testing at predetermined time periods during the study. If the viral load has not dropped more than two log at week 12 of standard therapy for hepatitis C then therapy will be stopped and the subject is considered a treatment failure. Similarly, if there was a greater than two log drop in the viral load at week 12 but there is still virus present in the blood at week 24 then therapy is stopped and the subject is considered treatment failure. If the virus is undetectable in the blood at week 12 and 24 then therapy is continued for the full 48 weeks. If the virus is detectable at week 48 then the subject is considered a treatment failure.
After this 48 week treatment period and the virus is still undetectable, there is a follow-up period consisting of 24 weeks off therapy. At the end of the 24 weeks, blood will be tested for the virus and if the virus is not present then the subject has a sustained viral response and is a treatment success.
During therapy if the subject becomes significantly anemic Procrit 40,000Units weekly injections will be started. Similarly, if the white blood cell count drops below a certain level then weekly Neupogen 300mcq injections will be started. In addition, if there is mild depressive symptoms treatment will be started but if there is major depressive symptoms, then therapy will be stopped and a referral to a psychiatrist will be made.
Type d'étude
Inscription (Anticipé)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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New York
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New York, New York, États-Unis, 10003
- Beth Israel Medical Center - Philipps Ambulatory Care Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Men and women at least 21 years of age.
- Positive serum hepatitis C RNA for at least 6 months.
- Naive to any therapy for hepatitis C infection.
- Significant steatosis or fat on the liver biopsy.
- Genotype 1 patients.
Exclusion Criteria:
- Subjects with decompensated liver disease.
- Hemoglobin <12g/dl.
- WBC<2,000mm3.
- ANC<1,000mm3.
- Platelet count<50,000/mm3.
- Creatinine>1.5mg/dl.
- Albumin<2.5g/dl.
- Bilirubin>4mg/dl.
- HIV or hepatitis B co-infection.
- History of other liver disease besides fatty liver disease.
- History of unstable cardiac or cerebrovascular disease.
- History of significant psychiatric disorders.
- Alcohol or drug abuse within last year.
- Pregnant or lactating women or men whose sexual partner is pregnant or lactating.
- Taking of insulin or oral hypoglycemic agents within six months of the study.
- Uncontrolled thyroid disorder.
- History of malignancy within the past 5 years unless cured by surgery.
- History of autoimmune disorder or organ transplantations requiring immunosuppression.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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To compare the efficacy of Rosiglitazone in combination with pegylated interferon alfa-2a and ribavirin (weight-based) to that of pegylated interferon alfa-2a and ribavirin alone in terms of sustained viral response.
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Mesures de résultats secondaires
Mesure des résultats |
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To compare the safety and tolerability of Rosiglitazone in combination with pegylated interferon-2a and ribavirin to that of pegylated interferon alfa-2a and ribavirin alone in terms of adverse events.
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Douglas Meyer, M.D., Beth Israel Medical Center
- Directeur d'études: Henry C. Bodenheimer, M.D., Beth Israel Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections transmissibles par le sang
- Maladies transmissibles
- Maladies du foie
- Infections à Flaviviridae
- Hépatite, virale, humaine
- Infections à entérovirus
- Infections à Picornaviridae
- Hépatite chronique
- Hépatite
- Hépatite A
- Hépatite C
- Foie gras
- Hépatite C chronique
- Agents hypoglycémiants
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-infectieux
- Agents antiviraux
- Antimétabolites
- Ribavirine
- Peginterféron alfa-2a
- Rosiglitazone
Autres numéros d'identification d'étude
- 098-04
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