Hepatitis C Eligibility NCT00299923 Inclusion Criteria Exclusion Criteria Hypersensitiveness to Interferon, PEG-IFN alfa-2a, Ribavirin and Amantadine or other ingredient of the drugs Yes
No
Ongoing pregnancy or breast feeding Yes
No
Male partners of women who are pregnant or with women without effective contraception Yes
No
Signs or symptoms of hepatocellular carcinoma Yes
No
Chronic HCV infection genotype 2, 4, 5 or 6 Yes
No
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. Yes
No
Any investigational drug < 6 weeks prior to the first dose of study drug Yes
No
Positive test for anti-HAV IgM, HBsAg, anti-HBc IgM, anti-HIV Yes
No
History or other evidence of a medical condition associated with chronic liver disease other than HCV Yes
No
History or other evidence of decompensated liver disease or a Child-Pugh score > 6. Yes
No
Hb <12 g/dL (<120 g/L) in women or <13 g/dL (<130 g/L) in men at screening Yes
No
Any patient with an increased baseline risk for anemia or for whom anemia would be medically problematic Yes
No
Neutrophil count <1,500 cells/mm3 and/or platelet count <90,000 cells/mm3 Yes
No
Serum creatinin concentration >1.5 mg/dl Yes
No
History of severe psychiatric disease, especially depression. Yes
No
History of a severe seizure disorder that can not be stabilized by medication Yes
No
History of immunologically mediated disease Yes
No
Chronic pulmonary disease associated with functional limitation Yes
No
History of severe cardiac disease Yes
No
History of major organ transplantation except corneatransplantation Yes
No
Evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study Yes
No
Thyroid dysfunction not adequately controlled Yes
No
Evidence of severe retinopathy or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension Yes
No
Evidence of active drug abuse within one year of study entry except of a prescribed stable opioid substitution Yes
No
Take of Memantine during study period Yes
No
Cardiomyopathy and myocarditis Yes
No
AV-Block II and III Yes
No
Pre-existing bradycardia < 55 counts/min Yes
No
Known QT-interval (QTc after Bazett > 420 ms) or recognized U-waves or congenital QT-syndrome Yes
No
History of severe ventricular arrhythmia incl. Torsade de pointes Yes
No
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) Yes
No
Patients with obstructive glaucoma Yes
No
Patients with excitableness and confusion Yes
No
Patients with delirium and exogenic psychosis in the anamnesis Yes
No
Prostataadenome Yes
No
Diuretic medication of the type combination Triamterene/ Hydrochlorothiazide Yes
No
Inability or unwillingness to provide informed consent or abide by the requirements of the study Yes
No
Medical Concepts 
