Recruiting

Comparison of Outcomes Between Low Dose Emicizumab and Extended Half-life Factor VIII With Pharmacokinetic-guided Prophylaxis in Clinically Severe Hemophilia A

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What is being tested

"Emicizumab", "HEMLIBRA®"

Drug
Who is being recruted

Blood Coagulation Disorders+12

+ Hemarthrosis

+ Hematologic Diseases

From 3 to 30 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2 & 3
Interventional
Study Start: June 2023
See protocol details

Summary

Principal SponsorChulalongkorn University
Study ContactNUCHANUN KESSAKORN, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 22, 2023

Actual date on which the first participant was enrolled.

This study is focused on comparing two treatments for individuals with severe Hemophilia A, a condition where blood does not clot properly, leading to excessive bleeding. The study looks at low-dose Emicizumab and low-dose extended half-life Factor VIII treatment. These treatments are being compared to see which one better reduces bleeding episodes and improves quality of life. This is important as it could lead to more effective and manageable treatment options for people with severe Hemophilia A. Participants in the study will receive either low-dose Emicizumab or low-dose Factor VIII. Emicizumab is administered as an injection, while Factor VIII is typically given intravenously. Researchers will measure outcomes such as the annual bleeding rate, joint health, and overall quality of life. The study will also explore how the body processes these treatments and note any side effects. This information will help determine the most effective and safe treatment for reducing bleeding in Hemophilia A patients.

Official TitleComparison of Outcomes Between Low Dose Emicizumab and Extended Half-life Factor VIII With Pharmacokinetic-guided Prophylaxis in Clinically Severe Hemophilia A
NCT06155955
Principal SponsorChulalongkorn University
Study ContactNUCHANUN KESSAKORN, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 3 to 30 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Coagulation DisordersHemarthrosisHematologic DiseasesHemic and Lymphatic DiseasesHemophilia AHemorrhageHemorrhagic DisordersJoint DiseasesMusculoskeletal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and SymptomsCoagulation Protein DisordersBlood Coagulation Disorders, InheritedGenetic Diseases, Inborn

Criteria

2 inclusion criteria required to participate
Severe or moderate Hemophilia A with baseline FVIII:C of <3 IU/dl or severe bleeding phenotype

Receiving low dose FVIII prophylaxis for at least 6 months

2 exclusion criteria prevent from participating
Detectable FVIII inhibitor at screening

Detectable FVIII inhibitor at screening Having other underlying diseases: Juvenile rheumatoid arthritis, metabolic bone diseases, or other conditions mimicking or causing joint diseases

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
2 mg per kilograms per dose in first month, loading every 2 weeks then every 4 weeks

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

King Chulalongkorn Memorial hospital

Bangkok, ThailandOpen King Chulalongkorn Memorial hospital in Google Maps
Recruiting
One Study Center