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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001503-23-AT

Enrollment

104

Registered

2016-07-14

Start date

2016-08-16

Completion date

Unknown

Last updated

2020-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired thrombotic thrombocytopenic purpura (TTP) MedDRA version: 20.0 Level: PT Classification code 10043648 Term: Thrombotic thrombocytopenic purpura System Organ Class: 10005329 - Blood and lymphatic system disorders

Interventions

Product Name: Caplacizumab (an anti-von Willebrand Factor Nanobody ALX-0081) Product Code: ALX-0081 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: CAPLACIZUMAB

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): •Proportion of subjects with TTP-related events, number of TTP-related events and time to event •Mortality rate during the study •Proportion of subjects with recurrence of disease, number of recurrences, and time to recurrence •Proportion of subjects with reported major thromboembolic events, number of events, and time to event •Cognitive function •Quality of life •Immunogenicity of (repeated) treatment with caplacizumab.;Main Objective: •To evaluate long-term safety and efficacy of caplacizumab •To evaluate safety and efficacy of repeated use of caplacizumab •To characterize long term impact of TTP ;Secondary Objective: Not applicable ;Timepoint(s) of evaluation of this end point: From screening until last follow-up visit	—

Measure

Time frame

Primary end point(s): •Proportion of subjects with TTP-related events, number of TTP-related events and time to event •Mortality rate during the study •Proportion of subjects with recurrence of disease, number of recurrences, and time to recurrence •Proportion of subjects with reported major thromboembolic events, number of events, and time to event •Cognitive function •Quality of life •Immunogenicity of (repeated) treatment with caplacizumab.;Main Objective: •To evaluate long-term safety and efficacy of caplacizumab •To evaluate safety and efficacy of repeated use of caplacizumab •To characterize long term impact of TTP ;Secondary Objective: Not applicable ;Timepoint(s) of evaluation of this end point: From screening until last follow-up visit

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable ;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

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

Contacts

Public ContactAblynx Clinical Operations

Ablynx NV

clinicaltrials@ablynx.com3292620000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026