Health Condition 1: null- Hemphilia A
Conditions
Interventions
Intervention1: NIL: NIL
Intervention2: RECOMBINATE FVIII: RECOMBINATE (rFVIII) is a glycoprotien synthesized by a genetically engineered CHO cell line.
The dose of rFVIII depends on the bleeding even
Sponsors
Baxter India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects who have clinically proven hemophiliaA 2.Subjects have been prescribed RECOMBINATE by their treating physician at their discretion 3.Subject may be of any age and the upper limit of age is 99. 4.Subject or parent/legally authorized representative has provided written informed consent
Exclusion criteria
Exclusion criteria: 1. Subject has known intolerance or allergic reaction to any of the constituents in the formulation of RECOMBINATE 2. Patients who have known hypersensitivity to Factor VIII concentrates or to any of the excipients or trace impurities; known hypersensitivity to bovine, murine, or hamster protein 3. Patients with severe cardiac diseases, including myocardial infarction, cardiac insufficiency class III or higher, etc. 4. Other diseases with clinical significance: alcohol abuse, drug abuse, emotional disturbance, and dysgnosia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the incidence of AEs, SAEs, Inhibitor formation, and Non-serious AEs in subjects receiving RECOMBINATE for on-demand treatment, prophylaxis, or surgical proceduresTimepoint: 24 MONTHS OF FOLLOW UP OF EACH PATIENT | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemostatic effectiveness in subjects receiving RECOMBINATE where adequate follow up is possibleTimepoint: 24 MONTHS OF FOLLOW UP FOR EACH PATIENT | — |
Countries
India
Contacts
Public ContactSharad Jain
Baxter India Pvt Ltd
Outcome results
None listed