The Safety of Emicizumab SC Injection in Korean Patients With Hemophilia A

Overview

To evaluate Safety and efficacy and pharmacokinetics, FVIII Inhibitor titers of Hemlibra subcutaneous injection (SC inj.) in Korean patients with Hemophilia A with FVIII inhibitors.

Full Title of Study: “Observational Study on the Safety of Hemlibra Subcutaneous Injection in Korean Patients With Hemophilia A”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 2024

Detailed Description

Target subject : 1. Patients with Hemophilia A with documented historical high-titer inhibitors ( >=5 BUs) against. 2. Patients who undergo the assessment after 24 weeks from the first administration of Hemlibra SC inj.

Interventions

  • Drug: Emicizumab subcutaneous injection
    • After obtaining the written consent, the inclusion/exclusion criteria will be confirmed and the subjects will administer this drug. After that, safety and efficacy and PK, FVIII inhibitor titers will be evaluated by follow-up observation.

Clinical Trial Outcome Measures

Primary Measures

  • Adverse events
    • Time Frame: for 24weeks
    • AEs will be described for AEs and Adverse Drug Reactions (ADRs), Adverse Events of Special Interest (AESIs), other important AEs. Severity, outcome, causal relationship with study drug, etc. of AEs will be analyzed.

Secondary Measures

  • Annualized Bleeding episode Rate (ABR)
    • Time Frame: for 24weeks
    • The number of bleeds will be also annualized for each patient using the following formula
  • Improvement of ABR prior to and after Hemlibra administration
    • Time Frame: at 24 week
    • 2) A comparison of ABR of 24 weeks prior to and after administration of Hemlibra will be described.

Participating in This Clinical Trial

Inclusion Criteria

1. Patients with Hemophilia A (congenital factor VIII deficiency) who will receive Hemlibra SC inj. according to medical judgement of investigator (Severe for Hemophilia A patients without FVIII inhibitors). 2. Signed informed consent form Exclusion Criteria:

1. Subjects who are hypersensitive to Emicizumab 2. Subjects who are hypersensitive to mouse or hamster protein 3. Subjects with myocardial infarction or the history who are prohibited from administering L-Arginine containing drug 4. 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) 5. Subjects who the investigator deems inappropriate for the study.

Gender Eligibility: Male

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • JW Pharmaceutical
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chuhl Joo Lyu, Prof, Principal Investigator, Severance Hospital
  • Overall Contact(s)
    • Chuhl Joo Lyu, Prof, +82222282060, CJ@yuhs.ac

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