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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00299923
Other study ID # ML 18545 (TRELA)
Secondary ID EudraCT-Nr.: 200
Status Active, not recruiting
Phase Phase 3
First received March 6, 2006
Last updated March 8, 2007
Start date November 2005

Study information

Verified date March 2007
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 300
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Peginterferon alfa-2a, Ribavirin, Amantadine


Locations

Country Name City State
Germany Universitätsklinikum des Saarlandes Bad Homburg/ Saar Saarland
Germany Charité, Campus Benjamin Franklin Berlin
Germany Charité, Campus Virchow-Klinikum, Med. Klinik (Gastroenterologie/ Hepatologie) Berlin
Germany Praxis Möller/ Heyne Berlin
Germany Klinikum der Ruhr-Universität Bochum Bochum Nordrhein-Westfalen
Germany Universitätsklinikum Bonn Bonn Nordrhein-Westfalen
Germany Klinikum Bremen-Mitte Bremen
Germany Universitätsklinikum Erlangen Erlangen Bayern
Germany J. W.-Goethe-Universität Frankfurt Hessen
Germany Universitätsklinikum Freiburg Freiburg Baden-Württemberg
Germany Klinikum der Medizinischen Fakultät der Martin-Luther Universität Halle-Wittenberg Halle (Saale) Sachsen-Anhalt
Germany Universitätsklinikum Hamburg-Eppendorf, Med. Klinik 1 Hamburg
Germany Medizinische Hochschule Hannover Hannover Niedersachsen
Germany Universitätsklinikum Heidelberg Heidelberg Baden-Württembeg
Germany Universitätsklinikum Schleswig-Holstein Kiel Schleswig-Holstein
Germany Klinikum der Universität Köln Köln Nordrhein-Westfalen
Germany Universitätsklinikum Schleswig-Holstein, Campus Lübeck Lübeck Schleswig-Holstein
Germany Johannes Gutenberg-Universität Mainz Mainz Rheinland-Pfalz
Germany Universitätsklinikum Mannheim Mannheim Baden-Würtemberg
Germany Klinikum rechts der Isar der TU München München Bayern
Germany Universitätsklinkum Münster Münster Nordrhein-Westfalen
Germany St-Josef-Hospital Oberhausen Nordrhein-Westfalen
Germany Klinikum der Universität Regensburg Regensburg Bayern
Germany Krankenhaus Barmherzige Brüder Regensburg Bayern
Germany Universität Rostock Rostock Mecklenburg-Vorpommern
Germany Universitätsklinikum Ulm Ulm Baden-Württemberg
Germany Klinikum der Universität Würzburg Würzburg Bayern

Sponsors (3)

Lead Sponsor Collaborator
University of Hamburg Hoffmann-La Roche, Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary - 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 relationship between EVR during the first twelve weeks and SVR
Secondary 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.
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