Prospective Follow-up Study for Patients who Completed Study ALX0681-C301 (HERCULES) to Evaluate Long-term Safety and Efficacy of Caplacizumab (Post-HERCULES)

Phase 3

Conditions: Thrombotic Thrombocytopenic Purpura
10038158

Registration Number: NL-OMON43030

Lead Sponsor: Ablynx NV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 8

Inclusion Criteria

1. Completed the Final (28 day) FU visit in Study ALX0681-C301.
2. Is >= 18 years of age at the time of signing the informed consent form (ICF).
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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Proportion of subjects with TTP-related events (defined as TTP-related death,<br /><br>recurrence of TTP or reported major thromboembolic event), number of<br /><br>TTP-related events and time to event<br /><br>• Mortality rate during the study<br /><br>• Proportion of subjects with recurrence of disease, number of recurrences, and<br /><br>time to recurrence<br /><br>• Proportion of subjects with reported major thromboembolic events (e.g.,<br /><br>myocardial infarction, cerebrovascular accident, pulmonary embolism or deep<br /><br>venous thrombosis), number of events, and time to event<br /><br>• Cognitive function<br /><br>• Quality of life<br /><br>• Immunogenicity of (repeated) treatment with caplacizumab</p><br>

Secondary Outcome Measures