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

University of Hamburg-Eppendorf

Status and phase

Unknown

Phase 3

Conditions

Hepatitis C, Chronic

Relapse

Treatments

Drug: Peginterferon alfa-2a, Ribavirin, Amantadine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00299923

EudraCT-Nr.: 2005-001207-19

ML 18545 (TRELA)

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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