Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038792
Status:
TERMINATED
Last Update Posted:
2012-08-02
First Post:
2002-06-05
Brief Title:
Phase III Trial rHuKFG for the Treatment of Steroid Refractory Gastrointestinal Acute GVHD
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase III Trial of Recombinant Human Keratinocyte Growth Factor rHuKFG for the Treatment of Steroid Refractory Gastrointestinal Acute Graft-versus-host Disease aGvHD
Status:
TERMINATED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase II efficacy evaluation phase III efficacy and toxicity trial of recombinant human keratinocyte growth factor for the treatment of steroid refractory gastrointestinal graft versus host disease
Detailed Description:
There are two processes that cause diarrhea as the clinical manifestation of graft versus host disease The first is the obvious immunologic attack on the colonic epithelium of the recipient Once this immunologic attack has been abated the recipient is left with a colonic mucosa that is devoid of microvilli and has a smooth intestinal boarder This is frequently subject to superinfections from bacteria all of which cause the diarrhea to continue Researchers only endpoint to measure clinical response of immunosuppression is the resolution of diarrhea The human recombinant keratinocyte growth factor stimulates the growth of colonic epithelium The growth of colonic epithelium will in turn probably ameliorate some of the diarrhea associated with graft versus host disease
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