A Phase III trial with caplacizumab in patients with acquired thrombotic thrombocytopenic purpura.

Phase 1

• Conditions: Acquired Thrombotic thrombocytopenic purpura; MedDRA version: 19.0Level: 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: EUCTR2015-001098-42-HU
• Lead Sponsor: Ablynx NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-04
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

1.Adult male or female = 18 years of age at the time of signing the informed consent form (ICF) or Male or female child (aged = 2 to < 12
years) or adolescent (aged = 12 to <18 years) at the time of obtaining
informed consent/assent (as applicable)
2.Clinical diagnosis of acquired TTP (initial or recurrent), which includes thrombocytopenia and microscopic evidence of red blood cell fragmentation (e.g. schistocytes)
3.Requires initiation of daily PE treatment and has received PE treatment prior to randomization and prior to start of first dose of study drug for pediatric subjects.
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 119
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

1.Platelet count =100×10E9/L
2.Serum creatinine level >200 µmol/L in case platelet count is > 30×109/L
3.Known other causes of thrombocytopenia
4.Congenital TTP (known at the time of study entry)
5.Pregnancy or breast-feeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified