Ignite Creation Date:
2024-05-05 @ 10:12 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01051076
Status:
COMPLETED
Last Update Posted:
2021-08-23
First Post:
2010-01-15
Brief Title:
Rescue Immunotolerance Study in Induction of Immune Tolerance ITI-Experienced Patients RESIST Experienced
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Immune Tolerance Induction Study in Patients With Severe Type A Haemophilia With Inhibitor After Failure of a Previous Induction of Immune Tolerance With FVII Concentrates Without Von Willebrand Factor Rescue
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
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:
RESIST EXP
Brief Summary:
The purpose of this study is to evaluate whether a concentrate containing both FVIII and von Willebrand Factor VWF given at a high dose will induce immune tolerance in subjects who have already experienced and failed ITI with VWF-free FVIII concentrates The treatment on this study is expected to last up to 33 months
Detailed Description:
The presence of Factor VIII FVIII inhibitor prevents FVIII infusions from working properly and makes treatment of bleeding episodes very difficult Having an inhibitor is a serious and life-threatening complication in patients with Hemophilia The usual treatment of patients with FVIII inhibitors involves what is called immune tolerance induction ITI Immune Tolerance means that the body can accept infused FVIII and that FVIII is again effective in controlling bleeds ITI involves giving high doses of FVIII regularly until the inhibitor disappears This treatment is not always effective The inhibitor persists in about 1 in 5 patients who undergo ITI
There are 2 types of FVIII concentrates FVIII concentrates derived from human plasma which contain VWF and concentrates of FVIII without VWF Both types of concentrates are commonly used to induce immune tolerance in patients with Hemophilia A Retrospective studies on subjects who were treated with VWF containing Factor VIII concentrates after failing ITI with pure factor VIII concentrates have shown that tolerance can be achieved in a large percentage of patients This study will access prospectively whether treatment with a FVIII concentrate containing VWF given at a high dose 200 units per kilogram daily for up to 33 months is able to induce immune tolerance after previous attempts with concentrates containing only FVIII have failed
There are 2 types of FVIII concentrates FVIII concentrates derived from human plasma which contain VWF and concentrates of FVIII without VWF Both types of concentrates are commonly used to induce immune tolerance in patients with Hemophilia A Retrospective studies on subjects who were treated with VWF containing Factor VIII concentrates after failing ITI with pure factor VIII concentrates have shown that tolerance can be achieved in a large percentage of patients This study will access prospectively whether treatment with a FVIII concentrate containing VWF given at a high dose 200 units per kilogram daily for up to 33 months is able to induce immune tolerance after previous attempts with concentrates containing only FVIII have failed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2008-007019-33 | EUDRACT_NUMBER | None | None |