NCT05728528

Impact of Moderate Intensity Physical Activities on PK-guided EHL FVIII Concentrates Prophylaxis Severe HA Patients

Impact of Moderate to Vigorous-intensity Physical Activities on Pharmacokinetic-guided Extended Half-life FVIII Concentrates Prophylaxis Severe Hemophilia A Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

To compare clinical outcomes before and after using combination between moderate to vigorous-intensity physical activities and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis in moderate to severe hemophilia A patients

Detailed description

This is a prospective cohort study of severe hemophilia A patients receiving low-dose EHL FVIII concentrates with PK-guided EHL FVIII concentrates prophylaxis alone for 6 months. Additional exercise workshops from sport scientists were introduced individually to this group of patients along with using the same prophylaxis method for another period of 6 months. The annualized bleeding rates (ABR), the annualized joint bleeding rates (AJBR), the haemophilia-specific quality-of-life (Haemo-QoL-A) scores, the hemophilia Joint Health Scores (HJHS) and skeletal muscle mass were compared between these two periods

Conditions

• Hemophilia

Interventions

Type	Name	Description
DRUG	combination between moderate to vigorous-intensity physical activities and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis	combination between moderate to vigorous-intensity physical activities and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis
DRUG	pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone	pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone

Timeline

• Start date: 2022-07-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2023-02-15
• Last updated: 2023-02-15

Locations

1 site across 1 country: Thailand