A clinical trial to study the efficacy and safety of low dose versus standard dose emicizumab prophylaxis in haemophilia A patients.
- Conditions
- Health Condition 1: D66- Hereditary factor VIII deficiency
- Registration Number
- CTRI/2024/01/061593
- Lead Sponsor
- Department of Health Research, India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
All persons with haemophilia A(PWH)with FVIII levels less than 2 percentage as seen in case notes with age ranging from 2 to 17 years
PWH with and without the presence of FVIII inhibitors
PWH with inhibitors not planning for immune tolerance induction or where immune
tolerance induction has failed
PWH with hepatitis and HIV
Parents or patients willing to signed and give written informed consent or assent as
appropriate
Children and caregivers willing to comply with scheduled visits, treatment plans, laboratory
tests, and other study procedures, including the questionnaires.
Written or verbal assent as appropriate from children participating in the study
Patients who will find it difficult to follow the protocol based on PI judgement
Patients posted for elective surgery
Inherited or acquired bleeding disorder other than hemophilia A
Ongoing Immune tolerance Induction therapy (prophylaxis regimens with FVIII and or
bypassing agents must be discontinued prior to enrollment)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method