Health Condition 1: D66- Hereditary factor VIII deficiency
Conditions
Interventions
Intervention1: Prophylactic factor VIII: Prophylactic factor VIII would be given thrice weekly in the dose of 15 IU per Kg per dose to the randomized prophylactic study arm for one year and the effect
Sponsors
Dr Sugandh Sareen
Eligibility
Inclusion criteria
Inclusion criteria: 1. Severe Hemophilia (Factor VIII levels 2. Age more than equal to 12 years to less than equal to 18 years at enrolment 3. more than equal to 6 treated joint bleeds in the previous one year 4. Inhibitor screen negavtive at enrolment 5. No evidence of hepatitis 6. Viral markers negative 7. Not on any prophylactic regimen in the last one year 8. Not on any non-factor replacement therapy
Exclusion criteria
Exclusion criteria: 1. Female Gender 2. Factor VIII levels >1% at diagnosis 3. Age 18 years at enrolment 4. 5. Inhibitor screen positive at enrolment 6. Evidence of hepatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annual Total Bleed Rate, Annual joint Bleed rate and quality of lifeTimepoint: Baseline before the study initiation and after one year of study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemophilia Joint Health Score, Incidence of inhibitors, Pettersson Joint score, IPSG MRI score, HEAD US scoring system, HAL/Ped-Hal, Functional Impairment Scoring for Hemophilia (FISH), Health Related Quality of lifeTimepoint: Inhibitor screening every 3 months Rest all parameters, at the start of the study protocol and end of one year. | — |
Countries
India
Contacts
Public ContactSugandh Sareen
Guru Gobind Singh Medical College and Hospital
Outcome results
None listed