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

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

Sponsors

Lead sponsor: UMC Utrecht

Source UMC Utrecht
Brief Summary

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

Detailed Description

The CIRA-study is a double blind, placebo controlled, randomised, multicentre study in previously untreated patients suffering from chronic hepatitis C comparing double therapy, consisting of (PEG-)interferon alpha 2b ((PEG)Intron-A®) and ribavirin (Rebetol®), with triple therapy, consisting of (PEG-)interferon alpha 2b, ribavirin and amantadine, for 52 weeks. Follow-up is completed at week 104. 150 Subjects per treatment group will be included. Patients will be stratified before randomisation according to genotype (1 versus non-1). Viral load will not be a discriminating factor.

The aim is to investigate the efficacy of the adjunct amantadine to the currently used combination therapy with interferon alpha and ribavirin.

Overall Status Completed
Start Date February 2000
Completion Date January 2007
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Response rate at end of treatment and end of follow-up (sustained response rate)
Enrollment 390
Condition
Intervention

Intervention type: Drug

Intervention name: Amantadine

Eligibility

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Location
facility UMC Utrecht
Location Countries

Netherlands

Verification Date

September 2005

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double

Source: ClinicalTrials.gov