Post marketing study to evaluate the side effects and bleeding controlling effectiveness of RECOMBINATE (Factor VIII) drug.
- Conditions
- Health Condition 1: null- Hemphilia A
- Registration Number
- CTRI/2011/11/002135
- Lead Sponsor
- Baxter India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 50
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
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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Hemostatic effectiveness in subjects receiving RECOMBINATE where adequate follow up is possibleTimepoint: 24 MONTHS OF FOLLOW UP FOR EACH PATIENT