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

Chulalongkorn University

Status and phase: Completed; Phase 4

Conditions: Hemophilia

Treatments: Drug: pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone; Drug: combination between moderate to vigorous-intensity physical activities and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis

Study type: Interventional

Funder types: Other

Identifiers

NCT05728528

996/2565

Details and patient eligibility

About

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

Full 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

Enrollment: 13 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe Hemophilia A patients

Exclusion criteria

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: combination between moderate to vigorous-intensity physical activities and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis

PK-guided EHL FVIII concentrates prophylaxis alone

Active Comparator group

Description:

PK-guided EHL FVIII concentrates prophylaxis alone

Treatment:

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