Comparison of Outcomes Between Low Dose Emicizumab and Factor VIII in Clinically Severe Hemophilia A

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

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06155955

Enrollment

Registered

2023-12-05

Start date

2023-06-22

Completion date

2024-06-21

Last updated

2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Joint Bleed, Severe Hemophilia A Without Inhibitor

Keywords

emicizumab, hemophilia A

Brief summary

* To outcome between low dose Emicizumab and low dose prophylaxis with FVIII concentration * To study pharmacokinetic, side effect of low dose Emicizumab

Detailed description

* To compare outcome between low dose Emicizumab and low dose prophylaxis with FVIII concentration using ABR, AJBR and HJHS, HaemoQoL * To study pharmacokinetic, side effect and effectiveness of low dose Emicizumab

Interventions

DRUGEmicizumab, HEMLIBRA®

low dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

3 Years to 30 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
spontaneous and traumatic bleeding rate	6 months after start low dose emicizumab as secondary prophylaxis treatment	Using Annualized bleeding rate (ABR)
treated spontaneous bleeds, treated joint bleeds	6 months after start low dose emicizumab as secondary prophylaxis treatment	Using Annualized joint bleeding rate (AJBR)
The function of the knee, elbow, and ankle joints	6 months after start low dose emicizumab as secondary prophylaxis treatment	Using Hemophilia Joint Health Score (HJHS)

Countries

Thailand

Contacts

Primary ContactNUCHANUN KESSAKORN, MD

nuchanun.ks@gmail.com662-5054639

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026