Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031148
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2002-02-26
Brief Title:
Keratinocyte Growth Factor to Prevent Acute GVHD
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
Phase III Trial of Keratinocyte Growth Factor rHuKGF to Prevent Acute GVHD in 66 HLABMT Recipients
Status:
COMPLETED
Status Verified Date:
2002-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study to determine the safety and efficacy of keratinocyte growth factor KGF to prevent acute graft-versus-host disease GVHD in patients undergoing allogeneic bone marrow BM or peripheral blood progenitor cell PBPC transplantation
Detailed Description:
GVHD remains the major complication of allogeneic BM transplantation and is initiated during the conditioning of the recipient for transplant when the host tissues are damaged Research has demonstrated that the gastrointestinal GI tract is a critical organ in GVHD pathophysiology Agents that protect the GI tract may provide prophylaxis against the cytokine cascade and can lead to a reduced incidence and severity of GVHD KGF is a protein that stimulates the growth of epithelial cells including those of the GI tract KGF can protect the GI tract prevent GVHD and preserve donor T-cell function
Patients will receive standard GVHD prophylaxis in addition to the study drug Overall GVHD will be graded weekly during the first 2 months after transplant then every other week to Day 100 Response to therapy will be measured through the use of severity indices physical exam and laboratory serum values
Patients will receive standard GVHD prophylaxis in addition to the study drug Overall GVHD will be graded weekly during the first 2 months after transplant then every other week to Day 100 Response to therapy will be measured through the use of severity indices physical exam and laboratory serum values
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FD-R-002021-01 | None | None | None |