NCT04165135

An Observational Study to Evaluate Physical Activity, Bleeding Incidence and Health Related Quality of Life, in Participants With Haemophilia A Without Inhibitors Receiving Standard of Care Treatment

A Multicenter, Non-Interventional Study to Evaluate Physical Activity, Bleeding Incidence and Health Related Quality of Life, in Patients With Haemophilia A Without Inhibitors Receiving Standard of Care Treatment

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 103 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 12 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, non-interventional, prospective study will collect information about activity status, bleeds, health-related quality of life (HRQoL), health status, and safety in participants with moderate or severe haemophilia A without factor VIII (FVIII) inhibitors, who are being treated in accordance with normal clinical practice.

Conditions

• Severe Hereditary Factor VIII Deficiency Disease Without Inhibitor
• Moderate Hereditary Factor VIII Deficiency Disease Without Inhibitor
• Haemophilia A

Interventions

Type	Name	Description
DRUG	Standard of Care for Haemophilia A	There is no pre-determined studied medicinal product. Any treatment (including treatments started during the observational period) will be administered according to standard clinical practice, independently of participation in the current study, according to clinician's independent therapeutic decision.

Timeline

• Start date: 2020-02-24
• Primary completion: 2022-04-28
• Completion: 2022-04-28
• First posted: 2019-11-15
• Last updated: 2024-07-12
• Results posted: 2024-07-12

Locations

17 sites across 1 country: Italy