A Survey of Susoctocog Alfa (Genetical Recombination) in Participants With Acquired Haemophilia A
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Susoctocog Alfa (Genetical Recombination).
- Who it may be relevant to
- Registry conditions: Acquired Hemophilia A. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
General Use-results Survey of OBIZUR for I.V. Injection (All-case Surveillance)
Overview
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).
Interventions
- Drug Susoctocog Alfa (Genetical Recombination)
Susoctocog Alfa (Genetical Recombination), Intravenous injection
Primary outcome measures
- Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE) [Time frame: 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)]
- Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) [Time frame: 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 outcome measures (2)
- Number of Participants with Each Score of Eastern Cooperative Oncology Group (ECOG) Performance Status [Time frame: 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)]
- Number of Participants for Categories of Treatment Effectiveness with Susoctocog Alfa (Genetical Recombination) as Assessed by the Investigator [Time frame: 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)]
Eligibility criteria
Inclusion criteria
\- All participants with Acquired Haemophilia A, treated with Susoctocog Alfa (Genetical Recombination).
Exclusion criteria
\- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Japan · 1 center
- Takeda selected site — Tokyo
Identifiers
NCT: NCT06461533 · TAK-672-4004 · jRCT2031240148