Trials / Terminated
TerminatedNCT00212472
International Immune Tolerance Study
An International Randomised Controlled Trial Of Immune Tolerance Induction
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 134 (actual)
- Sponsor
- New York Presbyterian Hospital · Academic / Other
- Sex
- All
- Age
- 7 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Subjects will be randomized into a low-dose or high-dose immune tolerance regimen and this study will compare the success rates, the time to achieve tolerance,the complications and the cost of both regimens.It will also aim to identify predictors of successful immune tolerance.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Factor VIII concentrates | To be determined at the discretion of the investigator. |
| OTHER | Low-dose treatment | 50 FVIII u/kg three times a week. |
| OTHER | High-dose treatment | 200 FVIII u/kg per day. |
Timeline
- Start date
- 2002-07-01
- Primary completion
- 2010-12-01
- Completion
- 2012-12-01
- First posted
- 2005-09-21
- Last updated
- 2009-12-07
Locations
39 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00212472. Inclusion in this directory is not an endorsement.