Condition category
Infections and Infestations
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
05/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr K J van Erpecum

ORCID ID

Contact details

University Medical Centre Utrecht (UMCU)
F02.618
P.O. Box 85500
Utrecht
3508 GA
Netherlands
K.J.vanerpecum@AZU.NL

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR145

Study information

Scientific title

Acronym

CIRA-study

Study hypothesis

Adding amantadine to the standard anti-HCV treatment can improve sustained response rates in chronic hepatitis C.

Ethics approval

Received from local medical ethics committee

Study design

Multicentre, randomised, double-blind, placebo-controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Hepatitis C

Intervention

One year treatment with interferon/ribavirin and amantadine or placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Amantadine, interferon/ribavirin

Primary outcome measures

Virological response at week 52 and 104.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

14/02/2000

Overall trial end date

01/05/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

390

Participant 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

Recruitment start date

14/02/2000

Recruitment end date

01/05/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Utrecht (UMCU)
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

University/education

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes