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Pharmacokinetics of 6-thioguanine.


- candidate number1225
- NTR NumberNTR429
- ISRCTNISRCTN49579665
- Date ISRCTN created27-feb-2007
- date ISRCTN requested18-nov-2005
- Date Registered NTR16-aug-2005
- Secondary IDsN/A 
- Public TitlePharmacokinetics of 6-thioguanine.
- Scientific TitlePharmacokinetics of 6-thioguanine.
- ACRONYMN/A
- hypothesisOral 6-thioguanine (6TG) results in a high intrahepatic exposure to 6TG generated metabolites.
- Healt Condition(s) or Problem(s) studiedScoliosis, Emollients, Crohn's disease
- Inclusion criteria1. IBD;
2. In need of immunosuppressants;
3. Intolerant to azathioprine or methotrexate.
- Exclusion criteria1. Concomittant use of drugs interfering with thiopurine metabolism;
2. Pregnancy/lactation.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-jun-2005
- planned closingdate1-jun-2006
- Target number of participants16
- InterventionsBlood draws.
- Primary outcomeDetermination of first pass effect of 6TG metabolites.
- Secondary outcomeDetermination of influence of different enzymes on 6TG metabolism.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES K.H.N. Boer, de
- CONTACT for SCIENTIFIC QUERIES K.H.N. Boer, de
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsN/A
- Brief summaryPatients will receive both 6TG orally and intravenously. On set times (for 8 hours) blood will be drawn to determine the concentrations of different metabolites and enzymes.
- Main changes (audit trail)
- RECORD16-aug-2005 - 18-nov-2008


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