Trials Sponsors Conditions Drugs Pricing

Conditions

Hemophilia A With Inhibitor Hemophilia A Without Inhibitor

Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

Annualized Bleeding episode Rate (ABR)
for 24weeks

Study Arms (2)

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

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

Interventions

Emicizumab subcutaneous injectionDrug

Safety and efficacy and PK, FVIII inhibitor titers will be evaluated by follow-up observation.

Also known as: Emicizumab concentration, FVIII inhibitor titer, FVIII Activity lab test

Hemophilia A with FVIII inhibitorsHemophilia A without FVIII inhibitors

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

JW Pharmaceutical
Industrylead

Study Sites (1)

Yonsei University Severance Hospital

Seoul, South Korea

RECRUITING

Chuhl-Joo Lyu, ProfCONTACT+82222282060 CJ@yuhs.ac

Biospecimen

Retention: SAMPLES WITHOUT DNA

Emicizumab Concentration Factor FVIII Inhibitor FVIII Activity

Study Officials

Chuhl Joo Lyu, Prof
Severance Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Chuhl Joo Lyu, Prof

CONTACT

+82222282060 CJ@yuhs.ac

YoungShil Park, Prof.

CONTACT

+8224407174

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: OTHER
Target Duration: 6 Months
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 17, 2021

First Posted

March 18, 2021

Study Start

August 28, 2019

Actual (reported)

Primary Completion

July 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Hemophilia A with FVIII inhibitors

Hemophilia A without FVIII inhibitors

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Hemophilia A with FVIII inhibitors

Hemophilia A without FVIII inhibitors

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations