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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00146016
• Date of registration: 01/09/2005
• Prospective Registration: No
• Primary sponsor: UMC Utrecht
• Public title: Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients
• Scientific title: Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients
• Date of first enrolment: February 2000
• Target sample size: 390
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00146016
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Netherlands

Contacts

• Name: Karel v. Erpecum, MD, PhD
• Affiliation: UMC Utrecht, dept. Gastroenterology

• Name: Melvin Samsom, MD, PhD
• Affiliation: UMC Utrecht, dept gastroenterology

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Hepatitis C

Intervention(s)

Drug: Amantadine

Primary Outcome(s)

Response rate at end of treatment and end of follow-up (sustained response rate)

Secondary ID(s)

CIRA-study

Source(s) of Monetary Support

Please refer to primary and secondary sponsors