TRELA

Auswirkung der Behandlungsdauer in Kombination mit Ribavirin und Amantadin bei Hepatitis C Relapsern

Rekrutierung

Die Studie rekrutiert aktuell Patienten.

Studiendesign

randomisiert, multizentrisch

Studienziel

Primary Outcomes: - Comparison of the rate of relapse under the combination of standard dose PegIFN alfa-2a, Ribavirin and Amantadine given for 72 vs. 48 weeks. Secondary Outcomes: - relationship between EVR during the first twelve weeks and SVR; - virological response to the combination of standard dose defined as reduction of HCV RNA at week 4, 12, 24, 48 and 72 of treatment, separated between HCV-Genotypes.

Synopsis

The aim of this study is, to compare the relapse rate in chronic HCV patients with genotype 1 or 3 under the combination of standard dose Peg-Interferon alfa-2a (PEG-IFN alfa-2a), Ribavirin (RBV) and Amantadine (AMA) given for 72 weeks (group A), versus the same combination, given for 48 weeks (group B) in patients who relapsed to previous combination therapy to conventional or pegylated (PEG) Interferon alfa and Ribavirin. Relapse ist defined as percentage of patients with non-detectable HCV-RNA at end of therapy (week 48 GT1/ week 24 GT 3) who become HCV-RNA positive during a follow-up period of 24 weeks.

Einschlusskriterien

  • Relapsers to previous combination therapy with (PEG-)IFN alfa-/Ribavirin and a negative HCV-RNA test result at the end of this regular treatment course and positive HCV-RNA test result during the follow-up period.
  • Termination of (PEG-)IFN alfa-/ribavirin therapy at least 3 months prior to enrolment
  • Chronic HCV infection genotype 1 or 3.
  • Serum HCV-RNA quantifiable at >100 IU/mL by COBAS AmpliPrep or another quantitative HCV-RNA PCR test (reported in IU)
  • Compensated liver disease (Child-Pugh A)
  • Exclusion of HCC in patients with cirrhosis or transition to cirrhosis. In patients with AFP >50 ng/mL an established assay for exclusion of HCC has to be done
  • Negative urine or blood pregnancy test
  • All fertile males and females must use two reliable forms of effective contraception (combined) during treatment with study drugs and 6 months post treatment

Ausschlusskriterien

  • Hypersensitiveness to Interferon, PEG-IFN alfa-2a, Ribavirin and Amantadine or other ingredient of the drugs
  • Ongoing pregnancy or breast feeding
  • Male partners of women who are pregnant or with women without effective contraception
  • Signs or symptoms of hepatocellular carcinoma
  • Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment < 6 months prior to the first dose of study drug and during study period. Exception: patients who have had a limited (< 7 days) course of acyclovir or valacyclovir for herpetic lesions < 1 month prior to the first administration of test drug are not excluded.
  • Any investigational drug < 6 weeks prior to the first dose of study drug
  • Hb <12 g/dL (<120 g/L) in women or <13 g/dL (<130 g/L) in men at screening
  • Neutrophil count <1,500 cells/mm3 and/or platelet count <90,000 cells/mm3
  • History of severe psychiatric disease, especially depression.
  • History of a severe seizure disorder that can not be stabilized by medication
  • History of major organ transplantation except corneatransplantation
  • Cardiomyopathy and myocarditis
  • AV-Block II° and III°
  • Known QT-interval (QTc after Bazett > 420 ms) or recognized U-waves or congenital QT-syndrome
  • Diuretic medication of the type combination Triamterene/ Hydrochlorothiazide

ClinicalTrials

Die Studie ist bei ClinicalTrials.gov unter der Registrierungsnummer clinicaltrials.gov/show/NCT00299923 angemeldet.
Studieninformationen bei ClinicalTrials.gov

Studienassistentin

Frau Anne Patruna-Pfaff, Telefon: 06131 17-5442, E-Mail

Studienleiter

Herr PD Dr. Wulf Böcher
Weitere Informationen

Leiter der klinischen Prüfung

Herr Dr. Peter Buggisch
Universitäts-Klinikum Hamburg-Eppendorf