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Status:

UNKNOWN

Study for Patients With Chronic HCV (GT 1 or 3) Who Relapsed to Previous (Peg)Interferon/ Ribavirin Combination Therapy

Lead Sponsor:

University of Hamburg-Eppendorf

Collaborating Sponsors:

Universitätsklinikum Hamburg-Eppendorf

Hoffmann-La Roche

Conditions:

Hepatitis C, Chronic

Relapse

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

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 ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • 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
  • Exclusion Criteria (at screening):
  • 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
  • Chronic HCV infection genotype 2, 4, 5 or 6
  • 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
  • Positive test for anti-HAV IgM, HBsAg, anti-HBc IgM, anti-HIV
  • History or other evidence of a medical condition associated with chronic liver disease other than HCV
  • History or other evidence of decompensated liver disease or a Child-Pugh score \> 6.
  • Hb \<12 g/dL (\<120 g/L) in women or \<13 g/dL (\<130 g/L) in men at screening
  • Any patient with an increased baseline risk for anemia or for whom anemia would be medically problematic
  • Neutrophil count \<1,500 cells/mm3 and/or platelet count \<90,000 cells/mm3
  • Serum creatinin concentration \>1.5 mg/dl
  • History of severe psychiatric disease, especially depression.
  • History of a severe seizure disorder that can not be stabilized by medication
  • History of immunologically mediated disease
  • Chronic pulmonary disease associated with functional limitation
  • History of severe cardiac disease
  • History of major organ transplantation except corneatransplantation
  • Evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
  • Thyroid dysfunction not adequately controlled
  • Evidence of severe retinopathy or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension
  • Evidence of active drug abuse within one year of study entry except of a prescribed stable opioid substitution
  • Take of Memantine during study period
  • Cardiomyopathy and myocarditis
  • AV-Block II° and III°
  • Pre-existing bradycardia \< 55 counts/min
  • Known QT-interval (QTc after Bazett \> 420 ms) or recognized U-waves or congenital QT-syndrome
  • History of severe ventricular arrhythmia incl. Torsade de pointes
  • Simultaneous therapy with Budipin or other medicine that extend the QT-interval like (e.g.antiarrhythmic drugs class IA and class III, antipsychotic drugs, tri- and tetracyclic antidepressants, antihistaminics, macrolide, gyrase inhibitors, Azol-antimykotics)
  • Patients with obstructive glaucoma
  • Patients with excitableness and confusion
  • Patients with delirium and exogenic psychosis in the anamnesis
  • Prostataadenome
  • Diuretic medication of the type combination Triamterene/ Hydrochlorothiazide
  • Inability or unwillingness to provide informed consent or abide by the requirements of the study

Exclusion

    Key Trial Info

    Start Date :

    November 1 2005

    Trial Type :

    INTERVENTIONAL

    End Date :

    Estimated Enrollment :

    300 Patients enrolled

    Trial Details

    Trial ID

    NCT00299923

    Start Date

    November 1 2005

    Last Update

    March 9 2007

    Active Locations (27)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 7 (27 locations)

    1

    Universitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106

    2

    Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, Germany, 89081

    3

    Universitätsklinikum Mannheim

    Mannheim, Baden-Würtemberg, Germany, 68167

    4

    Universitätsklinikum Heidelberg

    Heidelberg, Baden-Württembeg, Germany, 69120