Follow-up Study for Patients Who Completed Study ALX0681-C301 (Post-HERCULES)

• Register: ClinicalTrials.gov
• Last refreshed on: 4 April 2022
• Main ID: NCT02878603
• Date of registration: 04/08/2016
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: Follow-up Study for Patients Who Completed Study ALX0681-C301 (Post-HERCULES)
• Scientific title: Prospective Follow-up Study for Patients Who Completed Study ALX0681-C301 (HERCULES) to Evaluate Long-term Safety and Efficacy of Caplacizumab (Post-HERCULES)
• Date of first enrolment: October 6, 2016
• Target sample size: 104
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02878603
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Austria, Belgium, Canada, Czech Republic, Czechia, France, Hungary, Israel, Italy, Spain, Switzerland, Turkey, United Kingdom, United States

Contacts

• Name: Medical Director Ablynx, MD
• Affiliation: Ablynx NV

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Completed the Final (28 day) follow-up visit in Study ALX0681-C301.

2. >= 18 years of age at the time of signing the informed consent form.

3. Provided informed consent prior to initiation of any study specific
activity/procedure.

Exclusion Criteria:

1. Not being able/willing to comply with the study protocol procedures.

2. Currently enrolled in a clinical study with another investigational drug or device.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Acquired Thrombotic Thrombocytopenic Purpura

Intervention(s)

Biological: Caplacizumab

Other: Standard of Care

Primary Outcome(s)

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 [Time Frame: Baseline, Month 12, 24, and 36 Follow-up visits]

Number of Major Thromboembolic Events Including Thrombotic Thrombocytopenic Purpura [Time Frame: From Baseline up to 36 months]

Percentage of Participants With Recurrence of Disease (aTTP) [Time Frame: From Baseline up to 36 months]

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 [Time Frame: 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 [Time Frame: 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 [Time Frame: Baseline, Month 12, 24, and 36 Follow-up visits]

Number of Acquired Thrombotic Thrombocytopenic Purpura-related Events [Time Frame: From Baseline up to 36 months]

Number of Disease (aTTP) Recurrence Reported During the Study [Time Frame: From Baseline up to 36 months]

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 [Time Frame: Baseline, Month 12, 24, and 36 Follow-up visits]

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: From Baseline up to 36 months]

Percentage of Participants With Acquired Thrombotic Thrombocytopenic Purpura (aTTP) Related Events [Time Frame: From Baseline up to 36 months]

Percentage of Participants With Major Thromboembolic Events Including Thrombotic Thrombocytopenic Purpura (TTP) [Time Frame: From Baseline up to 36 months]

Time to First Major Thromboembolic Event [Time Frame: From Baseline up to 36 months]

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 [Time Frame: 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 [Time Frame: 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 [Time Frame: Baseline, Month 12, 24, and 36 Follow-up visits]

Percentage of Participants With Drug-induced Treatment-emergent (TE) Anti-drug Antibodies (ADA) Positive Response [Time Frame: From Baseline up to 36 months]

Number of Participants With aTTP Related Deaths Reported During the Study [Time Frame: From Baseline up to 36 months]

Time to First Acquired Thrombotic Thrombocytopenic Purpura-related Events [Time Frame: From Baseline up to 36 months]

Time to Recurrence of Disease (aTTP) [Time Frame: 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 [Time Frame: Baseline, 36 Months follow-up visit]

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 [Time Frame: 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 [Time Frame: Baseline, Month 12, 24, and 36 Follow-up visits]

Secondary ID(s)

2016-001503-23

ALX0681-C302

LTS16371

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 22/11/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02878603