Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00143546
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2017-04-25
First Post:
2005-09-01
Brief Title:
Compassionate Use of Defibrotide for Patients With Veno-occlusive Disease of the Liver
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Compassionate Use of Defibrotide for Patients With Veno-Occlusive Disease
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2017-04
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:
Veno-occlusive disease VOD of the liver is a significant complication for some patients undergoing hematopoietic stem cell transplantation This disease is thought to be a toxicity secondary to chemotherapy or radiation-induced damage to the epithelial cells of the blood vessels in the liver VOD is categorized as mild moderate or severe Historically there has been no method to treat the disease Recently however there have been investigations into the use of a new agent called defibrotide
The primary purpose of this protocol is to provide defibrotide to patients with severe VOD Because this drug has not been approved by the FDA use of this medication under the auspices of this IND treatment plan is for compassionate use only
The primary purpose of this protocol is to provide defibrotide to patients with severe VOD Because this drug has not been approved by the FDA use of this medication under the auspices of this IND treatment plan is for compassionate use only
Detailed Description:
Secondary objectives of this protocol include the following
To describe the toxicities of defibrotide in patients with VOD
To describe the response rate of VOD in patients receiving defibrotide
To describe the toxicities of defibrotide in patients with VOD
To describe the response rate of VOD in patients receiving defibrotide
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