Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

• Adding Amantadine to standard anti-viral treatment can improve sustained response rates in patients with chronic hepatitis C

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UMC Utrecht
• Treatments: Amantadine; Interferon-alpha; Interferons; Ribavirin

Criteria

Inclusion Criteria:

• Anti-HCV positivity >6 months

• ALT and/or AST elevation on at least once in the previous 6 months

• Positive HCV-RNA

• Liver biopsy within one year before the start of therapy in non- cirrhosis. In the case of known cirrhosis, liver biopsy is not necessary

• Intention to be treated and participate treatment

• Obtained written informed consent

Exclusion Criteria:

• Age < 18 years

• Pregnancy or intention to get pregnant within the 12 months period of treatment and up to 6 months after discontinuation of therapy, no adequate contraception, lactation

• Men not practicing or willing to practice acceptable methods of contraception during the treatment period and up to 6 months after discontinuation of therapy

• Life expectancy < 1 year

• Child Pugh B or C (Appendix III)

• Creatinine > 150 μmol/L or > 1.70 mg/dl

• Haemoglobulin < 6.5 mmol/l or < 10.5 g/dl

• White blood cell count < 2,5 x 109/L, neutrophil < 1,5 x 109/L

• Platelet count < 70 x 109/L

• HIV positivity

• Chemotherapy, systematical antiviral treatment during the 6 months prior to study entry

• Other serious disease (e.g. malignancy, uncontrolled myocardial disease or severe arrhythmias)

• Active uncontrolled psychiatric disorders and suicidal leanings

• Patients with a history of uncontrolled seizure or other significant CNS dysfunction

• Any condition which in the opinion of the (co-)investigator might interfere with the evaluation of the study objectives