Comparison of Outcomes Between Low Dose Emicizumab and Factor VIII in Clinically Severe Hemophilia A
NCT ID: NCT06155955
Last Updated: 2024-03-05
Study Results
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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RECRUITING
PHASE2/PHASE3
15 participants
INTERVENTIONAL
2023-06-22
2024-06-21
Brief Summary
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* To study pharmacokinetic, side effect of low dose Emicizumab
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Detailed Description
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* To study pharmacokinetic, side effect and effectiveness of low dose Emicizumab
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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low dose emicizumab
2 mg per kilograms per dose in first month, loading every 2 weeks then every 4 weeks
"Emicizumab", "HEMLIBRA®"
low dose
low dose factor VIII prophylaxis
factor VIII prophylaxis
No interventions assigned to this group
Interventions
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"Emicizumab", "HEMLIBRA®"
low dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Receiving low dose FVIII prophylaxis for at least 6 months
Exclusion Criteria
* Detectable FVIII inhibitor at screening Having other underlying diseases: Juvenile rheumatoid arthritis, metabolic bone diseases, or other conditions mimicking or causing joint diseases
3 Years
30 Years
MALE
Yes
Sponsors
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Chulalongkorn University
OTHER
Responsible Party
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Nuchanun Kessakorn, MD
MD
Principal Investigators
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NUCHANUN KESSAKORN
Role: PRINCIPAL_INVESTIGATOR
King Chulalongkorn Memorial Hospital
Locations
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King Chulalongkorn Memorial hospital
Bangkok, , Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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Kessakorn N, Gosriwatana I, Sasipong N, Srichumpuang C, Moonla C, Sosothikul D. Low-Dose Emicizumab Versus Low-/Intermediate-Dose Factor VIII Secondary Prophylaxis for Noninhibitor Haemophilia A Patients With Severe Bleeding Phenotype. Haemophilia. 2025 Jan;31(1):122-131. doi: 10.1111/hae.15146. Epub 2024 Dec 31.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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KingChulalongkorn
Identifier Type: -
Identifier Source: org_study_id
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