Prophylactic Vs Routine Replacement Therapy with Factor VIII In Hemophilia A Patients
Not Applicable
- Conditions
- Health Condition 1: D66- Hereditary factor VIII deficiency
- Registration Number
- CTRI/2023/02/049918
- Lead Sponsor
- Dr Sugandh Sareen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Severe Hemophilia (Factor VIII levels <1% at diagnosis)
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
1. Female Gender
2. Factor VIII levels >1% at diagnosis
3. Age <12 years or > 18 years at enrolment
4. <6 treated joint bleeds in the last one year.
5. Inhibitor screen positive at enrolment
6. Evidence of hepatitis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Annual Total Bleed Rate, Annual joint Bleed rate and quality of lifeTimepoint: Baseline before the study initiation and after one year of study.
- Secondary Outcome Measures
Name Time Method 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 <br/ ><br>Rest all parameters, at the start of the study protocol and end of one year.