A Survey of Susoctocog Alfa (Genetical Recombination) in Participants With Acquired Haemophilia A

Condition(s) studied

Investigational drug(s) / intervention(s)

Susoctocog Alfa (Genetical Recombination): Susoctocog Alfa (Genetical Recombination), Intravenous injection

Study 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

Primary outcome measure(s)

• Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE) — 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)
  An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
• Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) — 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)
  An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.

Trial sites (1)

More Takeda trials in Japan