The objectives of this study were to evaluate long-term safety and efficacy of caplacizumab, to evaluate safety and efficacy of repeated use of caplacizumab and to characterize long-term impact of acquired thrombotic thrombocytopenic purpura (aTTP).
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Percentage of Participants With Acquired Thrombotic Thrombocytopenic Purpura (aTTP) Related Events
Timeframe: From Baseline up to 36 months
Number of Acquired Thrombotic Thrombocytopenic Purpura-related Events
Timeframe: From Baseline up to 36 months
Time to First Acquired Thrombotic Thrombocytopenic Purpura-related Events
Timeframe: From Baseline up to 36 months
Number of Participants With aTTP Related Deaths Reported During the Study
Timeframe: From Baseline up to 36 months
Percentage of Participants With Recurrence of Disease (aTTP)
Timeframe: From Baseline up to 36 months
Number of Disease (aTTP) Recurrence Reported During the Study
Timeframe: From Baseline up to 36 months
Time to Recurrence of Disease (aTTP)
Timeframe: From Baseline up to 36 months
Percentage of Participants With Major Thromboembolic Events Including Thrombotic Thrombocytopenic Purpura (TTP)
Timeframe: From Baseline up to 36 months
Number of Major Thromboembolic Events Including Thrombotic Thrombocytopenic Purpura
Timeframe: From Baseline up to 36 months
Time to First Major Thromboembolic Event
Timeframe: From Baseline up to 36 months
Cognitive Function: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Absolute Scores at Baseline, 36 Months Follow-up Visit, and Change From Baseline in RBANS Total Score at 36 Months Follow-up Visit
Timeframe: Baseline, 36 Months follow-up visit
Health-Related Quality of Life (HRQoL): Change From Baseline in Headache Impact Test (HIT-6) Total Scores at Month 12, 24, and 36 Follow-up Visits
Timeframe: Baseline, Month 12, 24, and 36 Follow-up visits
Health-Related Quality of Life: Change From Baseline in 36-Item Short Form Questionnaire (SF-36) Health Survey - Physical Functioning Domain Scores at Month 12, 24, and 36 Follow-up Visits
Timeframe: Baseline, Month 12, 24, and 36 Follow-up visits
Health-Related Quality of Life: Change From Baseline in 36-Item Short Form Questionnaire Health Survey - Role Functioning/Physical Domain Scores at Month 12, 24, and 36 Follow-up Visits
Timeframe: Baseline, Month 12, 24, and 36 Follow-up visits
Health-Related Quality of Life: Change From Baseline in 36-Item Short Form Questionnaire Health Survey - Role Functioning/Emotional Domain Scores at Month 12, 24, and 36 Follow-up Visits
Timeframe: Baseline, Month 12, 24, and 36 Follow-up visits
Health-Related Quality of Life: Change From Baseline in 36-Item Short Form Questionnaire Health Survey - Energy/Fatigue Domain Scores at Month 12, 24, and 36 Follow-up Visits
Timeframe: Baseline, Month 12, 24, and 36 Follow-up visits
Health-Related Quality of Life: Change From Baseline in 36-Item Short Form Questionnaire Health Survey - Emotional Well-being Domain Scores at Month 12, 24, and 36 Follow-up Visits
Timeframe: Baseline, Month 12, 24, and 36 Follow-up visits
Health-Related Quality of Life: Change From Baseline in 36-Item Short Form Questionnaire Health Survey - Social Functioning Domain Scores at Month 12, 24, and 36 Follow-up Visits
Timeframe: Baseline, Month 12, 24, and 36 Follow-up visits
Health-Related Quality of Life: Change From Baseline in 36-Item Short Form Questionnaire Health Survey - Pain Domain Scores at Month 12, 24, and 36 Follow-up Visits
Timeframe: Baseline, Month 12, 24, and 36 Follow-up visits
Health-Related Quality of Life: Change From Baseline in 36-Item Short Form Questionnaire Health Survey - General Health Domain Scores at Month 12, 24, and 36 Follow-up Visits
Timeframe: Baseline, Month 12, 24, and 36 Follow-up visits
Health-Related Quality of Life: Change From Baseline in 36-Item Short Form Questionnaire Health Survey - Change in Health Status Scores at Month 12, 24, and 36 Follow-up Visits
Timeframe: Baseline, Month 12, 24, and 36 Follow-up visits
Percentage of Participants With Drug-induced Treatment-emergent (TE) Anti-drug Antibodies (ADA) Positive Response
Timeframe: From Baseline up to 36 months
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: From Baseline up to 36 months