A Phase II, single-blind, randomised, placebo-controlled trial to study the efficacy and safetyof anti-von Willebrand factor Nanobody administered as adjunctive treatment to patients withacquired thrombotic thrombocytopenic purpura - ND

Conditions: Acquired Thrombotic Thrombocytopenic Purpura (TTP).This population includes symptomatic patients with acute episodes of idiopathic TTP as wellas secondary TTP syndrome in association with clinical conditions or medicinal products (denovo and recurrent symptoms) requiring treatment with plasma exchange.
MedDRA version: 9.1Level: LLTClassification code 10043648
MedDRA version: 9.1Level: PTClassification code 10043648

Registration Number: EUCTR2010-019375-30-IT

Lead Sponsor: ABLYNX N.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 110

Inclusion Criteria

1. 18 years of age or older
2. Men or women willing to accept an acceptable contraceptive regimen
3. Patients with clinical diagnosis of TTP
4. Necessitating plasma exchange
5. Patient accessible to FU
6. Obtained, signed and dated informed consent
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Platelet count greater or equal to 100,000/µL
2. Severe active infection indicated by sepsis (requirement for pressors with or without
postive blood cultures)
3. Clinical evidence of enteric infection with E.coli 0157 or related organism
4. Anti-phospolipid syndrome
5. Diagnosis of disseminated intravascular coagulation (DIC)
6. Pregnancy or breast-feeding
7. Haematopoietic stem cell or bone marrow transplantation-associated thrombotic
microangiopathy
8. Known congenital TTP
9. Active bleeding or high risk of bleeding
10. Uncontrolled arterial hypertension
11. Known chronic treatment with anticoagulant treatment that can not be stopped safely,
including but not limited to:
? vitamin K antagonists
? heparin or LMWH
? non-acetyl salicylic acid non-steroidal anti-inflammatory molecules
12. Severe or life threatening clinical condition other than TTP that would impair
participation in the trial
13. Subjects with malignancies resulting in a life expectation of less than 3 months
14. Subjects with bone marrow carcinosis
15. Subjects who cannot comply with study protocol requirements and procedures.