NCT05728528

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2022

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

December 28, 2022

Last Update Submit

February 5, 2023

Conditions

Hemophilia

Outcome Measures

Primary Outcomes (4)

  • annualized bleeding rates (ABR)

    annualized bleeding rates (ABR)

    6 months

  • annualized joint bleeding rates (AJBR)

    annualized joint bleeding rates (AJBR)

    6 months

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

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

    6 months

  • hemophilia Joint Health Scores (HJHS)

    hemophilia Joint Health Scores (HJHS)

    6 months

Study Arms (2)

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

EXPERIMENTAL

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

PK-guided EHL FVIII concentrates prophylaxis alone

ACTIVE COMPARATOR

PK-guided EHL FVIII concentrates prophylaxis alone

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

Interventions

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

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
pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis aloneDRUG

pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone

PK-guided EHL FVIII concentrates prophylaxis alone

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Severe Hemophilia A patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Location

Related Publications (1)

  • Srichumpuang C, Rakmanotham A, Moonla C, Sosothikul D. Moderate- to vigorous-intensity physical activities for hemophilia A patients during low-dose pharmacokinetic-guided extended half-life factor VIII prophylaxis. Orphanet J Rare Dis. 2024 Mar 26;19(1):135. doi: 10.1186/s13023-024-03092-2.

    PMID: 38532451DERIVED

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Head of Integrative and Innovative Hematology/Oncology Research Unit at Faculty of Medicine, Chulalongkorn University.

Study Record Dates

First Submitted

December 28, 2022

First Posted

February 15, 2023

Study Start

July 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)