Ignite Creation Date:
2024-05-05 @ 11:45 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01400464
Status:
UNKNOWN
Last Update Posted:
2014-04-09
First Post:
2011-07-21
Brief Title:
Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis
Sponsor:
University Hospital Caen
Organization:
University Hospital Caen
Study Overview
Official Title:
Study the Link Between Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis
Status:
UNKNOWN
Status Verified Date:
2014-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREDICORT
Brief Summary:
The factors underlying the large interindividual variability in response to glucocorticoids in Giant Cell Arteritis are poorly understood The investigators hypothesize that a part of this variability is related to pharmacokinetic factors determined by genetic polymorphism hepatic clearance involving cytochromes P450 of the subfamily 3A CYP3A and drug efflux leukocyte conditioned by P-glycoprotein involved in multidrug resistance drugs ABCB1 The investigators have designed a multicentric prospective pharmacokinetical and pharmacogenetic cohort study to assess the link between prednisolone clearance and the relapse risk in giant cell arteritis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None