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

Primary Purpose

Hemophilia

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
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
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hemophilia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Severe Hemophilia A patients Exclusion Criteria: -

Sites / Locations

  • King Chulalongkorn Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PK-guided EHL FVIII concentrates prophylaxis with moderate intensity physical activities

PK-guided EHL FVIII concentrates prophylaxis alone

Arm Description

PK-guided EHL FVIII concentrates prophylaxis with moderate intensity physical activities

PK-guided EHL FVIII concentrates prophylaxis alone

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 28, 2022
Last Updated
February 5, 2023
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT05728528
Brief Title
Impact of Moderate Intensity Physical Activities on PK-guided EHL FVIII Concentrates Prophylaxis Severe HA Patients
Official Title
Impact of Moderate to Vigorous-intensity Physical Activities on Pharmacokinetic-guided Extended Half-life FVIII Concentrates Prophylaxis Severe Hemophilia A Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PK-guided EHL FVIII concentrates prophylaxis with moderate intensity physical activities
Arm Type
Experimental
Arm Description
PK-guided EHL FVIII concentrates prophylaxis with moderate intensity physical activities
Arm Title
PK-guided EHL FVIII concentrates prophylaxis alone
Arm Type
Active Comparator
Arm Description
PK-guided EHL FVIII concentrates prophylaxis alone
Intervention Type
Drug
Intervention Name(s)
combination between moderate to vigorous-intensity physical activities and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis
Intervention Description
combination between moderate to vigorous-intensity physical activities and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis
Intervention Type
Drug
Intervention Name(s)
pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone
Intervention Description
pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone
Primary Outcome Measure Information:
Title
annualized bleeding rates (ABR)
Description
annualized bleeding rates (ABR)
Time Frame
6 months
Title
annualized joint bleeding rates (AJBR)
Description
annualized joint bleeding rates (AJBR)
Time Frame
6 months
Title
haemophilia-specific quality-of-life (Haemo-QoL-A) scores
Description
haemophilia-specific quality-of-life (Haemo-QoL-A) scores
Time Frame
6 months
Title
hemophilia Joint Health Scores (HJHS)
Description
hemophilia Joint Health Scores (HJHS)
Time Frame
6 months

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Severe Hemophilia A patients Exclusion Criteria: -
Facility Information:
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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