Study on chronic hepatitis C treatment with interferon alpha, ribavirin and amantadine in naive patients.

Completed

• Conditions: Hepatitis C; Infections and Infestations; Chronic viral hepatitis

• Registration Number: ISRCTN74271466
• Lead Sponsor: niversity Medical Centre Utrecht (UMCU) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

1. Anti-HCV positivity; greater than 6 months
2. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) elevation on at least once in the previous 6 months
3. Positive hepatitis C virus ribonucleic acide (HCV-RNA)
4. Liver biopsy within one year before the start of therapy in non-cirrhosis. In the case of known cirrhosis, liver biopsy is not necessary.
5. Intention to be treated and participate treatment
6. Obtained written informed consent

Exclusion Criteria

1. Aged less than 18 years
2. 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
3. Men not practicing or willing to practice acceptable methods of contraception during the treatment period and up to 6 months after discontinuation of therapy
4. Life expectancy less than 1 year
5. Child Pugh B or C (Appendix III)
6. Creatinine greater than 150 µmol/L or greater than 170 mg/dl
7. Haemoglobin less than 65 mmol/l or less than 105 g/dl, white blood cell count less than 2.5 x 10^9/L, neutrophil less than 1.5 x 10^9/L, platelet count less than 70 x 10^9/L
8. Human immunodeficiency virus (HIV) positivity
9. Chemotherapy, systemical antiviral treatment during the 6 months prior to study entry
10. Other serious disease (e.g. malignancy, uncontrolled myocardial disease or severe arrhythmias)
11. Active uncontrolled psychiatric disorders and suicidal leanings
12. Patients with a history of uncontrolled seizure or other significant central nervous system (CNS) dysfunction
13. Any condition which in the opinion of the co-investigator might interfere with the evaluation of the study objectives

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Virological response at week 52 and 104.

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures