No registrations found.
ID
Source
Brief title
Health condition
Chronic hepatitis C
Sponsors and support
Prof. Dr. M. Samsom, hoofdonderzoker
UMC Utrecht
Huispostnummer F02.618
Postbus 85500
3508 GA Utrecht
Intervention
Outcome measures
Primary outcome
Virological response at week 52 and 104.
Secondary outcome
N/A
Background summary
This is a double blind, placebo controlled, randomised, multicentre study in previously untreated patients suffering from chronic hepatitis C comparing double therapy, consisting of interferon alpha 2b (Intron-A®) and ribavirin (Rebetol®), with triple therapy, consisting of 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.
Study objective
Adding amantadine to the standard anti-HCV treatment can improve sustained response rates in chronic hepatitis C.
Study design
N/A
Intervention
One year treatment with interferon/ribavirin and amantadine or placebo.
F02.618,
P.O. Box 85500
K.J. Erpecum, van
Utrecht 3508 GA
The Netherlands
K.J.vanerpecum@AZU.NL
F02.618,
P.O. Box 85500
K.J. Erpecum, van
Utrecht 3508 GA
The Netherlands
K.J.vanerpecum@AZU.NL
Inclusion criteria
1. Anti-HCV positivity; >6 months;
2. ALT and/or AST elevation on at least once in the previous 6 months;
3. Positive 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. Age < 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 < 1 year;
5. Child Pugh B or C (Appendix III);
6. Creatinine > 150 ìmol/L or > 1.70 mg/dl;
7. 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;
8. 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 arythmias);
11. Active uncontrolled psychiatric disorders and suicidal leanings;
12. Patients with a history of uncontrolled seizure or other significant CNS dysfunction;
13. Any condition which in the opinion of the (co-)investigator might interfere with the evaluation of the study objectives.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL114 |
| NTR-old | NTR145 |
| Other | : N/A |
| ISRCTN | ISRCTN74271466 |