Health Condition 1: null- HAEMOPHILIA A
Conditions
Interventions
Intervention1: MARKETED CLOTTING FACTOR VIII CONCENTRATES: 10 IU/KG ONCE A WEEK (OR) 20IU/KG THREE TIMES A WEEK - DOSE DIFFERS WITH THE TREATING CENTRE for 52 weeks
Intervention2: MARKETED CLOTTING FA
Sponsors
BAYER AWARD
Eligibility
Inclusion criteria
Inclusion criteria: 1. Severe hemophilia, defined as factor assay showing 2. No single joint should have an HJHS score of more than 5. 3. Not have detectable inhibitors by Bethesda assay ( 4. Be willing to come for evaluation once in 9-15 months for at least 2 (?4) years. (in case the study is extended)
Exclusion criteria
Exclusion criteria: PATIENTS WITH DOCUMENTED INHIBITORS. NOT WILLING TO COME FOR FOLLOW UP FOR LONG TERM (ATLEAST 4 YEARS)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the feasibility and impact of lower doses of prophylactic clotting factor concentrate (CFC) replacement therapy on the bleeding frequency and musculoskeletal outcome of children with severe hemophilia. 1.1.2 To correlate this outcome with the dose of CFC used and evaluate if there is a dose-response relationship at these doses.Timepoint: CLINICAL ASSESSMENTS, RADIOLOGICAL ASSESSMENTS, ORTHOPAEDIC ASSESSMENTS WILL BE DONE ONCE IN A YEAR AT YEAR-1,YEAR-2, YEAR-3 AND YEAR-4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.2.1 To familiarize and promote the use of prophylaxis with CFC for children with hemophilia in developing countries. 1.2.2 To encourage and standardize the assessment and documentation of musculoskeletal outcome in the participating centers for further dissemination to other centers in the country. 1.2.3 To create models for prophylactic CFC replacement therapy which are practical in developing countries during their evolution towards optimal hemophilia care.Timepoint: ANNUAL VISIT FOR 4 YEARS | — |
Countries
Brazil, Egypt, India, Malaysia, Sri Lanka
Contacts
Public ContactDr Alok Srivastava
Christian Medical College, Vellore
Outcome results
None listed