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

• Register: EUCTR
• Last refreshed on: 16 November 2020
• Main ID: EUCTR2016-001503-23-AT
• Date of registration: 14/07/2016
• Prospective Registration: Yes
• Primary sponsor: Ablynx NV
• 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: 16/08/2016
• Target sample size: 104
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001503-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Prospective follow-up for subject who completed study ALX0681-C301 If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Ablynx Clinical Operations
• Affiliation: Ablynx NV

• Name: Ablynx Clinical Operations
• Affiliation: Ablynx NV

Key inclusion & exclusion 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:
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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

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

Intervention(s)

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
CAS Number: 915810-67-2
Current Sponsor code: ALX-0081
Other descriptive name: ALX-0081
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 11.1-

Primary Outcome(s)

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

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.

Timepoint(s) of evaluation of this end point: From screening until last follow-up visit

Secondary Objective: Not applicable

Secondary Outcome(s)

Secondary end point(s): Not applicable

Timepoint(s) of evaluation of this end point: Not applicable

Secondary ID(s)

ALX0681-C302

Source(s) of Monetary Support

Ablynx NV

Ethics review

Status: Approved
Approval date: 03/08/2016
Contact: