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

Phase 1

• Conditions: Acquired thrombotic thrombocytopenic purpura (TTP); MedDRA version: 20.0Level: PTClassification code 10043648Term: Thrombotic thrombocytopenic purpuraSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2016-001503-23-IT
• Lead Sponsor: ABLYNX NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-18
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Each potential subject must satisfy all of the following criteria to be enrolled in the study:
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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

Exclusion Criteria

The criteria for exclusion are the following:
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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: ¿To evaluate long-term safety and efficacy of caplacizumab<br>¿To evaluate safety and efficacy of repeated use of caplacizumab<br>¿To characterize long term impact of TTP<br>;Secondary Objective: Not applicable ;Primary end point(s): <br>•Proporzione di soggetti con gli eventi correlati a PTT , numero di eventi correlati con la TTP e tempo all'evento <br>•Tasso di mortalità durante lo studio<br>•Proporzione dei soggetti con recidiva della patologia, numero di recidive e tempo alla recidiva <br>•Proporzione di soggetti che hanno riportato eventi tromboembolici gravi , numero di eventi e tempo all'evento <br>•Funzioni cognitive <br>•Qualità della vita <br>•Immunogenicità del trattamento (ripetuto) con caplacizumab<br>;Timepoint(s) of evaluation of this end point: from screening until last follow-up visit

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable ;Timepoint(s) of evaluation of this end point: Not applicable