HemophiliaPhase 4NCT05728528

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

A Phase 4 study testing combination between moderate to vigorous-intensity physical activities and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone in people with Hemophilia, run by Chulalongkorn University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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 Read more about this study

Who is it for?: Any age, men only
Conditions the study is for: Hemophilia
What is being tested?: combination between moderate to vigorous-intensity physical activities and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteThailand
Study dates: 1 Jul 2022to 31 Dec 2022
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Men only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Severe Hemophilia A patients

Who cannot join

Trial locations and contacts

1 site in 1 country.

Thailand1 site

King Chulalongkorn Memorial Hospital
Bangkok, 10330

Other trials in Thailand

About this study

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

Read the 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

Conditions: Hemophilia
Being tested: 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
Medical subject headings: Hemophilia A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05728528
Study group	Role	What they receive
PK-guided EHL FVIII concentrates prophylaxis with moderate intensity physical activities	Experimental	PK-guided EHL FVIII concentrates prophylaxis with moderate intensity physical activities Receives: 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 Receives: Drug: pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone

What is being measured

The primary outcome is the main question the study is designed to answer.

annualized bleeding rates (ABR)
annualized bleeding rates (ABR)
Measured: 6 months
annualized joint bleeding rates (AJBR)
annualized joint bleeding rates (AJBR)
Measured: 6 months
haemophilia-specific quality-of-life (Haemo-QoL-A) scores
haemophilia-specific quality-of-life (Haemo-QoL-A) scores
Measured: 6 months
hemophilia Joint Health Scores (HJHS)
hemophilia Joint Health Scores (HJHS)
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202231 Dec 2022

First posted15 Feb 2023
Study start1 Jul 2022
Primary completion31 Dec 2022
Study completion31 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HemophiliaStudies of the same condition, open and under way.
More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05728528
Sponsor's protocol ID: 996/2565
Status last verified: Feb 2023
First submitted: 28 Dec 2022
Last updated: 15 Feb 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 38532451

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B

All Hemophilia trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Moderate to Vigorous-intensity Physical Activities on Pharmacokinetic-guided Extended Half-life FVIII Concentrates Prophylaxis Severe Hemophilia A Patients
ClinicalTrials.gov ID: NCT05728528
Acronym / sponsor ID: 996/2565
Conditions: Hemophilia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Chulalongkorn UniversityUniversity, hospital or other
Study start: 1 Jul 2022 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 31 Dec 2022 (actual)
First posted: 15 Feb 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PK-guided EHL FVIII concentrates prophylaxis with moderate intensity physical activities	Experimental	Drug: combination between moderate to vigorous-intensity physical activities and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxisPK-guided EHL FVIII concentrates prophylaxis with moderate intensity physical activities
PK-guided EHL FVIII concentrates prophylaxis alone	Active comparator	Drug: pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alonePK-guided EHL FVIII concentrates prophylaxis alone

Who may qualify

Sex: Male only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Severe Hemophilia A patients

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
combination between moderate to vigorous-intensity physical activities and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxiscombination between moderate to vigorous-intensity physical activities and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis	Drug	PK-guided EHL FVIII concentrates prophylaxis with moderate intensity physical activities
pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alonepharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone	Drug	PK-guided EHL FVIII concentrates prophylaxis alone

Primary outcome

annualized bleeding rates (ABR)
Time frame: 6 months
annualized bleeding rates (ABR)
annualized joint bleeding rates (AJBR)
Time frame: 6 months
annualized joint bleeding rates (AJBR)
haemophilia-specific quality-of-life (Haemo-QoL-A) scores
Time frame: 6 months
haemophilia-specific quality-of-life (Haemo-QoL-A) scores
hemophilia Joint Health Scores (HJHS)
Time frame: 6 months
hemophilia Joint Health Scores (HJHS)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
Derived from this study: PubMed 38532451Srichumpuang 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.
Individual participant dataSharing planned: No

Related trials for Hemophilia

RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

annualized bleeding rates (ABR) (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05728528, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.