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

July 15, 2021 updated by: JW Pharmaceutical

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Target subject :

  1. Patients with Hemophilia A with FVIII inhibitors
  2. Patients with severe Hemophilia A without FVIII inhibitors.

Study Type

Observational

Enrollment (Anticipated)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chuhl Joo Lyu, Prof
  • Phone Number: +82222282060
  • Email: CJ@yuhs.ac

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Yonsei University Severance Hospital
        • Contact:
          • Chuhl-Joo Lyu, Prof
          • Phone Number: +82222282060
          • Email: CJ@yuhs.ac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

1 .Hemophilia A patients with FVIII inhibitors 2. Severe Hemophilia A patients without FVIII inhibitors

Description

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

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hemophilia A with FVIII inhibitors
Hemophilia A patients with FVIII inhibitors will administer Emicizumab at a loading dose of 3 mg/kg/week SC for the first 4 weeks of treatment followed by 1.5 mg/kg QW SC or 3mg/kg Q2W or 6mg/kg Q4W
Drug: Emicizumab subcutaneous injection
Safety and efficacy and PK, FVIII inhibitor titers will be evaluated by follow-up observation.
Other Names:
  • Emicizumab concentration, FVIII inhibitor titer, FVIII Activity lab test
Hemophilia A without FVIII inhibitors
Hemophilia A patients without FVIII inhibitors will administer Emicizumab at a loading dose of 3 mg/kg/week SC for the first 4 weeks of treatment followed by 1.5 mg/kg QW SC or 3mg/kg Q2W or 6mg/kg Q4W
Drug: Emicizumab subcutaneous injection
Safety and efficacy and PK, FVIII inhibitor titers will be evaluated by follow-up observation.
Other Names:
  • Emicizumab concentration, FVIII inhibitor titer, FVIII Activity lab test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
for 24weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized Bleeding episode Rate (ABR)
Time Frame: for 24weeks
The number of bleeds will be also annualized for each patient using the following formula
for 24weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JW Pharmaceutical

Investigators

  • Principal Investigator: Chuhl Joo Lyu, Prof, Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 28, 2019

Primary Completion (ANTICIPATED)

July 1, 2024

Study Completion (ANTICIPATED)

February 1, 2025

Study Registration Dates

First Submitted

March 17, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (ACTUAL)

March 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 15, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JWP-HEM-401

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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