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

Hemophilia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05728528
• Other study ID #: 996/2565
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Severe Hemophilia A patients Exclusion Criteria: -

Related Conditions & MeSH terms

• Hemophilia
• Hemophilia A

Intervention

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
• pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone
pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	annualized bleeding rates (ABR)	annualized bleeding rates (ABR)	6 months
Primary	annualized joint bleeding rates (AJBR)	annualized joint bleeding rates (AJBR)	6 months
Primary	haemophilia-specific quality-of-life (Haemo-QoL-A) scores	haemophilia-specific quality-of-life (Haemo-QoL-A) scores	6 months
Primary	hemophilia Joint Health Scores (HJHS)	hemophilia Joint Health Scores (HJHS)	6 months