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

Hemophilia A With Inhibitor Clinical Trial

Official title:

Observational Study on the Safety of Hemlibra Subcutaneous Injection in Korean Hemophilia A Patients With/Without FVIII Inhibitors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04805801
• Other study ID #: JWP-HEM-401
• Status: Recruiting
• Start date: August 28, 2019
• Est. completion date: February 2025

Study information

• Verified date: July 2021
• Source: JW Pharmaceutical
• Contact: Chuhl Joo Lyu, Prof
• Phone: +82222282060
• Email: CJ[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Target subject : 1. Patients with Hemophilia A with FVIII inhibitors 2. Patients with severe Hemophilia A without FVIII inhibitors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 17
• Est. completion date: February 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients with Hemophilia A (congenital factor VIII deficiency) who will receive Hemlibra SC inj. according to medical decision by investigator

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.

6. Moderate/Mild for Hemophilia A patients without FVIII inhibitors

Related Conditions & MeSH terms

• Hemophilia A
• Hemophilia A With Inhibitor
• Hemophilia A Without Inhibitor

Intervention

Drug:
• Emicizumab subcutaneous injection
Safety and efficacy and PK, FVIII inhibitor titers will be evaluated by follow-up observation.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	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.	for 24weeks
Secondary	Annualized Bleeding episode Rate (ABR)	The number of bleeds will be also annualized for each patient using the following formula	for 24weeks