Health Related Quality of Life of Youth and Young Adults With Haemophilia A

• Status: Recruiting
• Trial end date: 2022-11-15
• Target enrollment: 0
• Participant gender: All

Summary

Research question:

Whether there are the changes in quality of life in patients with haemophilia A after switching from SHL FVIII prophylaxis to efmoroctocog alfa prophylaxis?

A 12-month prospective open-label, single-arm multicentre study. Evaluation of parameters will be carried out on the backdrop of patient treatment in the settings of routine medical practice. No medical examinations/ procedures/ treatment(s) on the top of regular medical practice are planned, except fixed time of examinations.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The League of Clinical Research, Russia
• Treatments: Factor VIII; Immunoglobulin Fc Fragments

Criteria

Inclusion Criteria:

1. Signed consent form.

2. Adults, adolescents and children (12-25 years old) with haemophilia A with ABR ≥ 2 on at least one-year SHL FVIII prophylaxis.

Exclusion Criteria:

1. Patients who have had hypersensitivity reactions to efmoroctocog alfa or other constituents of the product.

2. History of Factor VIII inhibitors.

3. Patients who have other haemostatic disorders.

4. Patients participating in interventional studies.