A Survey of Susoctocog Alfa (Genetical Recombination) in Participants With Acquired Haemophilia A
ConditionAcquired Hemophilia A
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorTakeda
About this trial
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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
The population of this survey are all participants who meet the inclusion/exclusion criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Susoctocog Alfa (Genetical Recombination)
DrugSusoctocog Alfa (Genetical Recombination), Intravenous injection
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Susoctocog Alfa (Genetical Recombination)1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE)
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.
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)2
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
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.
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 outcomes
1
Number of Participants with Each Score of Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG scale will be used to assess performance status of participants. ECOG is a grade, where grade 0: Normal activity. Grade 1: Symptoms but ambulatory. Grade 2: In bed \<50% of the time. Grade 3: In bed \>50% of the time. Grade 4: 100% bedridden. Grade 5: Dead.
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)2
Number of Participants for Categories of Treatment Effectiveness with Susoctocog Alfa (Genetical Recombination) as Assessed by the Investigator
Number of participants for categories of treatment effectiveness with Susoctocog Alfa (Genetical Recombination) will be reported. Investigator will assess participants with following categories; Effective (Bleeding stopped and Clinically controlled), Partially Effective (Blood loss decreased, and Clinically stable, improvement, or bleeding for the other reason), Ineffective (Blood loss slightly decreased or unchanged and Clinically unstable), Not Effective (Worsening of bleeding and Clinically worsening).
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) Source ClinicalTrials.gov