UnknownNot Applicable

The Safety of Emicizumab SC Injection in Korean Hemophilia A Patients With/Without FVIII Inhibitors

South Korea17 participantsStarted 2019-08-28

Plain-language summary

To evaluate Safety and efficacy and pharmacokinetics, FVIII Inhibitor titers of Hemlibra subcutaneous injection (SC inj.) in Korean Hemophilia A patients with/without FVIII Inhibitors.

Who can participate

SexALL

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Inclusion criteria

✓. Patients with Hemophilia A (congenital factor VIII deficiency) who will receive Hemlibra SC inj. according to medical decision by investigator
✓. Signed informed consent form

Exclusion criteria

✕. Subjects who are hypersensitive to Emicizumab
✕. Subjects who are hypersensitive to mouse or hamster protein
✕. Subjects with myocardial infarction or the history who are prohibited from administering L-Arginine containing drug
✕. Subjects who participated in other clinical trials within a month before enrollment (or the first administration of Hemlibra SC inj.) (Unable to participate in other clinical trials related to Hemophilia A treatment even after enrollment)
✕. Subjects who the investigator deems inappropriate for the study.
✕. Moderate/Mild for Hemophilia A patients without FVIII inhibitors

What they're measuring

Adverse events

Timeframe: for 24weeks

Trial details

NCT IDNCT04805801

SponsorJW Pharmaceutical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-07

Contact for this trial

Chuhl Joo Lyu, Prof

+82222282060 CJ@yuhs.ac

View on ClinicalTrials.gov More Hemophilia A With Inhibitor trials