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

JRCT ID: jRCT2031240148

Registered date:10/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Acquired Haemophilia A
• Date of first enrollment: 10/06/2024
• Target sample size: 25
• Study type: Observational

Outcome(s)

Primary Outcome

1.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 (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.

2.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 (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.

Secondary Outcome

1.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, and 90 days after the last dose or discontinuation of study drug (varied from participant to participant)
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.

2.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 at the last dose or discontinuation of study drug (varied from participant to participant)
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).

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: All participants with Acquired Haemophilia A, treated with Susoctocog Alfa (Genetical Recombination).
• Exclude criteria: Not Applicable

Related Information

• Primary Sponsor: Contact for Clinical Trial Information