A Study of OBIZUR in Adults With Acquired Hemophilia A (AHA) in South Korea
ConditionAcquired Hemophilia A
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTakeda
About this trial
Acquired hemophilia A (AHA) is a rare bleeding condition which prevents blood clotting. Acquired means that people are not born with this condition or have a family history of blood clotting conditions. People living with AHA can have sudden and severe bleeding. They also have longer bleeding compared to people without AHA.
The main aim of the study is to learn how safe OBIZUR is in adults with AHA.
Other aims are to see how effective OBIZUR is to control bleeding and how treatment is used in a routine clinical practice setting.
The treatment of the participants will be determined by the treating physicians.
During the study, data already existing in the participants' medical record and new data will be collected.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants with AHA.
Participants who are determined to have the clinical need to receive Obizur treatment.
Participants aged 18 years or older at time of initiation of Obizur treatment.
Participants agreed to participate in the study and voluntarily signed the informed consent.
Disqualifiers
Participants with hypersensitivity to any of the components of this drug.
Participants with Congenital Hemophilia A with Inhibitors (CHAWI).
Participants for whom Obizur treatment is contraindicated as per product label.
Participants who has participated in another clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving a medicinal product or device during the course of the study.
Trial population
Participants with AHA who are receiving OBIZUR Injection or initiate OBIZUR Injection treatment for the first time will be enrolled.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
OBIZUR
DrugOBIZUR injection.
Treatment groups
9 Participants
are divided into 1 treatment groupGroup A: All Participants1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With Adverse Events (AEs), Causality to AEs, Serious AEs (SAEs) and AEs of Special Interest (AESI)
Number of participants with AEs, causality to AEs, SAEs and AESI will be reported. The investigator will assess the causal relationship (causality) between the medicinal product and the AE using his/her clinical expertise and judgment.
Time frame
Up to 3 months2
Number of Participants With Expected/Unexpected AEs and SAEs
Unexpected AE is defined as AE that differs from the information in the product label in nature, severity, specificity, or outcome.
Time frame
Up to 3 months3
Number of Participants With Adverse Drug Reactions (ADRs), Unexpected ADRs, Serious ADRs, Expected SADRs and Unexpected SADRs
An ADR refers to any undesirable and unintended reaction which occurs during or following the administration of the drug, and in which a causal relationship with the drug cannot be ruled out. In the event that a causal relationship with the drug remains unknown amongst reported adverse events, such reaction shall be considered an adverse drug reaction. Serious ADR means noxious or unintended response to a drug that occurs at any dosage and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. Unexpected ADRs is defined as ADR that differs from the information in the product label in nature, severity, specificity, or outcome.
Time frame
Up to 3 months4
Number of Participants With Special Situation Report (SSR)
SSR include following events: Pregnancy: any case in which a pregnancy participant is exposed to a Takeda Product or in which a female participant or partner of a male participant becomes pregnant following Takeda product.; Breastfeeding: infant exposure from breast milk; Overdose: all information of any accidental or intentional overdose; Drug abuse, misuse or medication error: all information on medicinal product (MP) abuse, misuse of medication error (potential or actual); Suspected transmission of infectious agent: Suspected (in sense of confirmed or potential) transmission of infectious agent by a MP; Lack of efficacy of Takeda Product; accidental/occupational exposure; Use outside the terms of the marketing authorization, also known as "off-label" and "off-label use"; Use of falsified and counterfeit MP; Drug-drug and drug-food interactions; Inadvertent or accidental exposure with or without an AE; Unintended benefit.
Time frame
Up to 3 monthsSecondary outcomes
1
Percentage of Participants With Overall Bleeding Control
Overall Bleeding Control will be determined as either bleeding stopped or did not stop.
Time frame
Up to 3 months2
Time to Achieve Bleeding Control With OBIZUR Injection
Time to achieve bleeding control will be assessed from initiation of OBIZUR Injection (start time) to the time to achieve bleeding control (stop time).
Time frame
Up to 3 months3
Number of OBIZUR Injection Infusion Required to Achieve Bleeding Control
Number of OBIZUR injection infusion required to achieve bleeding control will be reported.
Time frame
Up to 3 months4
Dose of OBIZUR Required to Stop the Bleeding
OBIZUR dose required to stop the bleeding will be reported.
Time frame
Up to 3 months Source ClinicalTrials.gov