ADVATE Hemophilia A Outcome Database (AHEAD)
| Status: | Recruiting |
|---|---|
| Conditions: | Anemia, Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/31/2015 |
| Start Date: | June 2011 |
| End Date: | December 2019 |
| Contact: | Manfred Pirck |
| Email: | manfred_pirck@baxter.com |
ADVATE Hemophilia A Outcome Database
The purpose of the study is to document the natural history of hemophilia. A disease and
long-term outcomes in terms of effectiveness, safety and quality of life (QoL) in
participants receiving ADVATE in routine clinical practice. Participants may use any
treatment regimen, including on-demand and prophylaxis using standardized regimens or
individual pharmacokinetic (PK)-guided dosing regimens, or immune tolerance induction (ITI)
therapy, as determined by the treating physician.
long-term outcomes in terms of effectiveness, safety and quality of life (QoL) in
participants receiving ADVATE in routine clinical practice. Participants may use any
treatment regimen, including on-demand and prophylaxis using standardized regimens or
individual pharmacokinetic (PK)-guided dosing regimens, or immune tolerance induction (ITI)
therapy, as determined by the treating physician.
Inclusion Criteria:
- Participant has hemophilia A (Factor VIII (FVIII) ≤5%)
- Participant is prescribed ADVATE by the treating physician
- Participant or participant's legally authorized representative provides informed
consent
Exclusion Criteria:
- Participant has known hypersensitivity to the active substance or any of the
excipients
- Participant has known allergic reaction to mouse or hamster proteins
- Participant has participated in another clinical study involving an investigational
product (IP) or device within 30 days prior to study enrollment or is scheduled to
participate in another clinical study involving another FVIII concentrate or device
during the course of this study
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