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

Sponsor
Chulalongkorn University (Other)
Overall Status
Completed
CT.gov ID
NCT05728528
Collaborator
(none)
13
Enrollment
1
Location
2
Arms
6
Actual Duration (Months)
2.2
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • 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
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Impact of Moderate to Vigorous-intensity Physical Activities on Pharmacokinetic-guided Extended Half-life FVIII Concentrates Prophylaxis Severe Hemophilia A Patients
Actual Study Start Date :
Jul 1, 2022
Actual Primary Completion Date :
Dec 31, 2022
Actual Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: PK-guided EHL FVIII concentrates prophylaxis with moderate intensity physical activities

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

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
Active Comparator: PK-guided EHL FVIII concentrates prophylaxis alone

PK-guided EHL FVIII concentrates prophylaxis alone

Drug: pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone
pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone

Outcome Measures

Primary Outcome Measures

  1. annualized bleeding rates (ABR) [6 months]

    annualized bleeding rates (ABR)

  2. annualized joint bleeding rates (AJBR) [6 months]

    annualized joint bleeding rates (AJBR)

  3. haemophilia-specific quality-of-life (Haemo-QoL-A) scores [6 months]

    haemophilia-specific quality-of-life (Haemo-QoL-A) scores

  4. hemophilia Joint Health Scores (HJHS) [6 months]

    hemophilia Joint Health Scores (HJHS)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Severe Hemophilia A patients
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 King Chulalongkorn Memorial Hospital Bangkok Thailand 10330

Sponsors and Collaborators

  • Chulalongkorn University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Darintr Sosothikul, Associate Professor, Head of Integrative and Innovative Hematology/Oncology Research Unit at Faculty of Medicine, Chulalongkorn University., Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT05728528
Other Study ID Numbers:
  • 996/2565
First Posted:
Feb 15, 2023
Last Update Posted:
Feb 15, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hemophilia A
Factor VIII

Study Results

No Results Posted as of Feb 15, 2023