Clinical trial NCT06461533: A Survey of Susoctocog Alfa (Genetical Recombination) in Participants With Acquired Haemophilia A
Official title: General Use-results Survey of OBIZER for I.V. Injection (All-case Surveillance)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acquired Hemophilia A
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2024-06-17
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population of this survey are all participants who meet the inclusion/exclusion criteria.

Brief summary: This study is a survey in Japan of Susoctocog Alfa (Genetical Recombination) intravenous injection used to treat participants with bleeding events of acquired Haemophilia A (AHA). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

The main aim of the study is to check for side effects related from Susoctocog Alfa (Genetical Recombination) intravenous injection and to check if Susoctocog Alfa (Genetical Recombination) intravenous injection improves bleeding events of AHA.

During the study, participants with AHA will take Susoctocog Alfa (Genetical Recombination) intravenous injection according to their clinic's standard practice. The study doctors will check for side effects from Susoctocog Alfa (Genetical Recombination) intravenous injection for up to 90 days after the last dose of study drug or until discontinued (varied from participant to participant).


Eligibility criteria: Inclusion Criteria:

- All participants with Acquired Haemophilia A, treated with Susoctocog Alfa (Genetical Recombination).

Exclusion Criteria:

- None

Primary outcomes:
measure: Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE)
timeFrame: From first dose of study drug up to 90 days after the last dose of study drug or until discontinued, whichever came first (varied from participant to participant)
measure: Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
timeFrame: From first dose of study drug up to 90 days after the last dose of study drug or until discontinued, whichever came first (varied from participant to participant)
Secondary outcomes:
measure: Number of Participants with Each Score of Eastern Cooperative Oncology Group (ECOG) Performance Status
timeFrame: Pre-dose, at the last dose or discontinuation of study drug, whichever came first, and 90 days after the last dose or discontinuation of study drug, whichever came first (varied from participant to participant)
measure: Number of Participants for Categories of Treatment Effectiveness with Susoctocog Alfa (Genetical Recombination) as Assessed by the Investigator
timeFrame: 24 hours after the first dose of study drug, and the last dose for bleeding episode or discontinuation of study drug, whichever came first (varied from participant to participant)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda selected site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: