- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
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New York
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New York, New York, Stati Uniti, 10003
- Beth Israel Medical Center - Philipps Ambulatory Care Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
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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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Misure di risultato secondarie
Misura del risultato |
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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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Douglas Meyer, M.D., Beth Israel Medical Center
- Direttore dello studio: Henry C. Bodenheimer, M.D., Beth Israel Medical Center
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie del fegato
- Flaviviridae Infezioni
- Epatite, virale, umana
- Infezioni da enterovirus
- Infezioni da Picornaviridae
- Epatite cronica
- Epatite
- Epatite A
- Epatite C
- Fegato grasso
- Epatite C, cronica
- Agenti ipoglicemizzanti
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti antinfettivi
- Agenti antivirali
- Antimetaboliti
- Ribavirina
- Peginterferone alfa-2a
- Rosiglitazone
Altri numeri di identificazione dello studio
- 098-04
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Fegato grasso
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Medical College of WisconsinRitiratoModello alto per il punteggio MELD (end-stage Liver Disease).Stati Uniti
Prove cliniche su Rosiglitazone and Pegasys/Ribavirin
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Casa Sollievo della Sofferenza IRCCSUniversity of Palermo; University of Florence; Campus Bio-Medico University; IRCCS... e altri collaboratoriCompletato