Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
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
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Condition
Hepatitis C
Intervention
One year treatment with interferon/ribavirin and amantadine or placebo.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Amantadine, interferon/ribavirin
Primary outcome measure
Virological response at week 52 and 104.
Secondary outcome measures
No secondary outcome measures
Overall study start date
14/02/2000
Overall study end date
01/05/2007
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Sex
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
Study participating centre
University Medical Centre Utrecht (UMCU)
Utrecht
3508 GA
Netherlands
Sponsor information
Organisation
University Medical Centre Utrecht (UMCU) (Netherlands)
Sponsor details
PO Box 85500
Utrecht
3508 GA
Netherlands
Sponsor type
University/education
Website
http://www.umcutrecht.nl/zorg/
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|