FindTrial
Sign In

A Study in Patients with Severe Haemophilia A and B

Adenovirus-Associated Virus Antibodies in Indian Cohort of Haemophilia A and B Patients: A Seroprevalence Study of the Presence of Neutralizing Activity and Antibodies Against Adenovirus-Associated Virus Vector Serotypes in Patients with Severe Haemophilia A and B

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/11/021956
Enrollment
150
Registered
2019-11-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D689- Coagulation defect, unspecified

Interventions

Intervention1: NIL: NIL

Sponsors

Dr Savita Rangarajan
Lead Sponsor

Eligibility

Inclusion criteria

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 should be willing to provide written informed consent and subject should be willing to give assent for the study.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Seroprevalence of AAV Neutralizing Factors and AntibodiesTimepoint: Day 1—

Secondary

MeasureTime frame
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. 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—

Countries

India

Contacts

Public ContactDr Savita Rangarajan

K.J. Somaiya Medical College and Research Centre

rangarajansavita@gmail.com9619525341

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026