NCT02216084 - Phase 1 Dose Escalation, Single Dose Study to Assess Safety and Pharmacokinetics of BAX930 in Hereditary Thrombotic Thrombocytopenic Purpura (TTP) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

February 22, 2016

Study Completion Date

February 22, 2016

Conditions

Hereditary Thrombotic Thrombocytopenic Purpura (TTP)

Interventions

DRUG

Recombinant ADAMTS13

"rADAMTS13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13) is a lyophilized formulation for intravenous injection. The lyophilized rADAMTS13 is reconstituted with sterile water for injection.~Subjects will receive an intravenous injection with rADAMTS13 at a dose of either 5 U/kg bodyweight (Cohort 1), or 20 U/kg bodyweight (Cohort 2), or 40 U/kg bodyweight (Cohort 3)."

Trial Locations (11)

1090

General Hospital Vienna (Allgemeines Krankenhaus der Stadt Wien), Vienna

3010

Inselspital - Universitaetsspital Bern, Bern

20246

Universitätsklinikum Hamburg-Eppendorf, Hamburg

43017

Ohio State University Medical Center, Dublin

77030

The Methodist Hospital Research Institute, Houston

97239

Oregon Health & Science University, Portland

07743

Universitätsklinikum Jena, Jena

113-8519

• Tokyo Medical and Dental University Hospital, Faculty of Medicine, Bunkyo-ku, Tokyo

663-8501

Hyogo College of Medicine Hospital, Department of Hematology, Nishinomiya-shi

02776

Institute of Hematology and Transfusion Medicine, Warsaw

NW1 2BU

University College London Hospital NHS Foundation Trust, London

All Listed Sponsors

lead

Baxalta now part of Shire

INDUSTRY