drugset / Trial / NCT00212472
International Immune Tolerance Study
Terminated
134 enrolled
New York Presbyterian Hospital
Manchester University NHS Foundation Trust · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to see if a low-dose arm or a high dose-arm of immune tolerance is more effective in eliminating inhibitors in patients with hemophilia A.
Timeline
- Start
- 2002-07
- Primary completion
- 2010-12
- Completion
- 2012-12
Outcome
Outcome not reported
Stopped: “The DSMB recommended stopping the study due to safety concerns.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Factor VIII concentrates | Unknown | 50 iu/kg | — |
| Comparator | Factor VIII concentrates | Unknown | 200 iu/kg | — |