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

ISRCTN	ISRCTN74271466
DOI	https://doi.org/10.1186/ISRCTN74271466
Protocol serial number	NTR145
Sponsor	University Medical Centre Utrecht (UMCU) (Netherlands)
Funder	Not provided at time of registration

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 05/11/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr K J van Erpecum
Scientific

University Medical Centre Utrecht (UMCU)
F02.618
P.O. Box 85500
Utrecht
3508 GA
Netherlands

Email	K.J.vanerpecum@AZU.NL

Study information

Primary study design	Interventional
Study design	Multicentre, randomised, double-blind, placebo-controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	CIRA-study
Study objectives	Adding amantadine to the standard anti-HCV treatment can improve sustained response rates in chronic hepatitis C.
Ethics approval(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	Hepatitis C
Intervention	One year treatment with interferon/ribavirin and amantadine or placebo.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Amantadine, interferon/ribavirin
Primary outcome measure(s)	Virological response at week 52 and 104.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/05/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	390
Key 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
Key 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
Date of first enrolment	14/02/2000
Date of final enrolment	01/05/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Centre Utrecht (UMCU)

Utrecht
3508 GA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan