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

NCT ID: NCT05728528

Last Updated: 2023-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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

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Hemophilia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

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

Intervention Type 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

PK-guided EHL FVIII concentrates prophylaxis alone

Group Type ACTIVE_COMPARATOR

pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone

Intervention Type DRUG

pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone

Interventions

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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

Intervention Type DRUG

pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone

pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Severe Hemophilia A patients

Exclusion Criteria

\-
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Darintr Sosothikul

Associate Professor, Head of Integrative and Innovative Hematology/Oncology Research Unit at Faculty of Medicine, Chulalongkorn University.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type DERIVED
PMID: 38532451 (View on PubMed)

Other Identifiers

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996/2565

Identifier Type: -

Identifier Source: org_study_id

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