Study to Assess Efficacy and Safety of Anti-von Willebrand Factor (vWF) Nanobody in Patients With… (NCT01151423) | Clinical Trial Compass
CompletedPhase 2
Study to Assess Efficacy and Safety of Anti-von Willebrand Factor (vWF) Nanobody in Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)
United States75 participantsStarted 2011-01
Plain-language summary
This study was a Phase II, single-blind, randomized, placebo-controlled trial to determine whether anti-vWF Nanobody is safe and effective as adjunctive treatment in patients with aTTP.
Patients received either placebo or anti-vWF Nanobody as adjunctive therapy to plasma exchange (PE).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 18 years of age or older (adults) or aged 12 to \< 18 years (adolescents)
* Male or female subject, willing to accept an acceptable contraceptive regimen
* Subject with a clinical diagnosis of TTP
* Requiring PE (one single PE session prior to randomization into the study was allowed)
* Subject accessible to follow-up
* Subject able to provide signed and dated informed consent and assent (if applicable, for adolescents)
Exclusion Criteria:
* Platelet count ≥ 100,000/µL
* Severe active infection indicated by sepsis (requirement for pressors with or without positive blood cultures)
* Clinical evidence of enteric infection with Escherichia coli 0157 or related organism
* Anti-phospholipid syndrome
* Diagnosis of disseminated intravascular coagulation (DIC)
* Pregnancy or breast-feeding
* Hematopoietic stem cell or bone marrow transplantation-associated thrombotic microangiopathy
* Known with congenital TTP
* Active bleeding or high risk of bleeding
* Uncontrolled arterial hypertension
* Known chronic treatment with anticoagulant treatment that cannot be stopped safely, including but not limited to:
* vitamin K antagonists
* heparin or low molecular weight heparin (LMWH)
* non-acetyl salicylic acid non-steroidal anti-inflammatory molecules
* Severe or life threatening clinical condition other than TTP that would impair participation in the study
* Subjects with malignancies resulting in a life expectation of less than 3 months
* Subjects with known…
What they're measuring
1
Time-to-response of Treatment Defined by a Confirmed Recovery of Platelets ≥ 150,000/µL
Timeframe: From the day of first study drug administration up to 30 days after first study drug administration