No registrations found.
ID
NL-OMON23696
Source
NTR
Brief title
N/A
Health condition
Crohn's disease of ulcerative colitis (IBD).
Sponsors and support
Primary sponsor
:
N/A
Source(s) of monetary or material Support
:
N/A
Intervention
Outcome measures
Primary outcome
Determination of first pass effect of 6TG metabolites.
Secondary outcome
Determination of influence of different enzymes on 6TG metabolism.
Background summary
Patients 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.
Study objective
Oral 6-thioguanine (6TG) results in a high intrahepatic exposure to 6TG generated metabolites.
Study design
N/A
Intervention
Blood draws.
Public
VU University Medical Center, Department of Gastroenterology and Hepatology,
P.O. Box 7057
K.H.N. Boer, de
Amsterdam 1007 MB
The Netherlands
KHN.deBoer@vumc.nl
P.O. Box 7057
K.H.N. Boer, de
Amsterdam 1007 MB
The Netherlands
KHN.deBoer@vumc.nl
Scientific
VU University Medical Center, Department of Gastroenterology and Hepatology,
P.O. Box 7057
K.H.N. Boer, de
Amsterdam 1007 MB
The Netherlands
KHN.deBoer@vumc.nl
P.O. Box 7057
K.H.N. Boer, de
Amsterdam 1007 MB
The Netherlands
KHN.deBoer@vumc.nl
Inclusion criteria
1. IBD;
2. In need of immunosuppressants;
3. Intolerant to azathioprine or methotrexate.
Exclusion criteria
1. Concomittant use of drugs interfering with thiopurine metabolism;
2. Pregnancy/lactation.
Design
Study type
:
Interventional
Intervention model
:
Parallel
Allocation
:
Non-randomized controlled trial
Masking
:
Open (masking not used)
Control
:
N/A , unknown
Recruitment
NL
Recruitment status
:
Recruitment stopped
Start date (anticipated)
:
Enrollment
:
16
Type
:
Actual
Positive opinion
Date
:
Application type
:
First submission
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 | NL389 |
| NTR-old | NTR429 |
| Other | : N/A |
| ISRCTN | ISRCTN49579665 |
Summary results
N/A