Follow-up Study for Patients who Completed Study ALX0681-C301 (Post-HERCULES)
- Conditions
- Acquired thrombotic thrombocytopenic purpura (TTP)MedDRA version: 20.0Level: PTClassification code 10043648Term: Thrombotic thrombocytopenic purpuraSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2016-001503-23-AT
- Lead Sponsor
- Ablynx NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 104
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
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 Primary end point(s): •Proportion of subjects with TTP-related events, number of TTP-related events and time to event <br>•Mortality rate during the study<br>•Proportion of subjects with recurrence of disease, number of recurrences, and time to recurrence <br>•Proportion of subjects with reported major thromboembolic events, number of events, and time to event <br>•Cognitive function <br>•Quality of life <br>•Immunogenicity of (repeated) treatment with caplacizumab.;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 ;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