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

Phase 4

Completed

• Conditions: Hemophilia
• Interventions: Drug: 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

• Registration Number: NCT05728528
• Lead Sponsor: Chulalongkorn University

Brief 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

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-12-28
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-05
• Last Update Submitted: 2023-02-05
• Study First Posted: 2023-02-15
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 13

Inclusion Criteria

• Severe Hemophilia A patients

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PK-guided EHL FVIII concentrates prophylaxis with moderate intensity physical activities	combination between moderate to vigorous-intensity physical activities and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis	PK-guided EHL FVIII concentrates prophylaxis with moderate intensity physical activities
PK-guided EHL FVIII concentrates prophylaxis alone	pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone	PK-guided EHL FVIII concentrates prophylaxis alone

Primary Outcome Measures

Name	Time	Method
hemophilia Joint Health Scores (HJHS)	6 months	hemophilia Joint Health Scores (HJHS)
annualized bleeding rates (ABR)	6 months	annualized bleeding rates (ABR)
annualized joint bleeding rates (AJBR)	6 months	annualized joint bleeding rates (AJBR)
haemophilia-specific quality-of-life (Haemo-QoL-A) scores	6 months	haemophilia-specific quality-of-life (Haemo-QoL-A) scores

Trial Locations

Locations (1)

King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand