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NCT02922231 Clinical Trial

Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea

Hemophilia B Clinical Trial

Official title:
Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02922231
Other study ID # 251501
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 6, 2017
Est. completion date April 4, 2019

Study information
Verified date April 2021
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Primary: To characterize the safety of RIXUBIS when used under normal clinical care in South Korea. Secondary: To describe hemostatic effectiveness in subjects receiving RIXUBIS under normal clinical care in South Korea.

Recruitment information / eligibility
Status Completed
Enrollment 57
Est. completion date April 4, 2019
Est. primary completion date April 4, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Participants with congenital hemophilia B (FIX level =5%) 2. Participant or the participant's legally authorized representative has provided signed informed consent. 3. Participant is indicated for treatment according to the RIXUBIS Korean product leaflet. Exclusion Criteria: 1. Participants with known hypersensitivity or presence of any contraindication to RIXUBIS or its excipients including hamster protein 2. Participants with Disseminated Intravascular Coagulation (DIC) 3. Participants with signs of fibrinolysis

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• RIXUBIS
Recombinant Factor IX (rFIX) for intravenous use

Locations
Country Name City State
Korea, Republic of Daegu Catholic University Medical Center Daegu
Korea, Republic of DaeJeon Eulji University Hospital Daejeon
Korea, Republic of Chung Hospital Gyeonggi-do
Korea, Republic of Kim Hugh Chul Internal Medicine Seoul
Korea, Republic of Korea Hemophilia Foundation Seoul

Sponsors (1)
Lead Sponsor Collaborator
Baxalta now part of Shire

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of adverse events (AEs) Seriousness and severity of AEs, including any inhibitory antibody development and/or anaphylactic reactions Throughout the study period of approximately 2 years and 6 months
Secondary Physician rated effectiveness of RIXUBIS for prophylactic treatment in participants <12 years old Rated on a 4-point ordinal scale: Excellent, Good, Moderate, or none Up to 6 months from baseline while on treatment
Secondary Participant rated effectiveness of RIXUBIS for prophylactic treatment in participants =12 years old Rated on a 4-point ordinal scale: Excellent, Good, Moderate, or none Up to 6 months from baseline while on treatment
Secondary Physician rated effectiveness of RIXUBIS for on-demand treatment in participants <12 years old Rated on a 4-point ordinal scale: Excellent, Good, Moderate, or none Up to 6 months from baseline while on treatment
Secondary Participant rated effectiveness of RIXUBIS for on-demand treatment in participants =12 years old Rated on a 4-point ordinal scale: Excellent, Good, Moderate, or none Up to 6 months from baseline while on treatment
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