A Study in Patients with Severe Haemophilia A and B
Not Applicable
- Conditions
- Health Condition 1: D689- Coagulation defect, unspecified
- Registration Number
- CTRI/2019/11/021956
- Lead Sponsor
- Dr Savita Rangarajan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Patients with known diagnosis of severe
Haemophilia A and B
2.Patients previously treated with FVIII
and FIX concentrates
3.Patients who are >= 15 years of age
4.Able to understand the study
procedures, the risks involved, willing
to provide written Informed Consent.
For patients <18 years of age, parents
should be willing to provide written
informed consent and subject should be
willing to give assent for the study.
Exclusion Criteria
1.Bleeding disorder(s) other than
haemophilia A or B.
2.Patients lacking mental capacity to
consent to the trial
3.Haemophilia A and B patients not
previously treated with FVIII and FIX
concentrates
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Seroprevalence of AAV Neutralizing Factors and AntibodiesTimepoint: Day 1
- Secondary Outcome Measures
Name Time Method 1.To investigate the difference in seroprevalence of AAV neutralizing factors and antibodies between patients treated with plasma derived FVIII and FIX replacement therapy as compared to recombinant FVIII and FIX replacement therapy. <br/ ><br> <br/ ><br>2.To investigate the difference in seroprevalance of AAV neutralizing factors and antibodies in patients with transfusion transmitted infection as compared to naïve patients.Timepoint: Day 1