A Study of BAX 930 in Children, Teenagers, and Adults Born With Thrombotic Thrombocytopenic Purpura (TTP)

PHASE3CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

October 13, 2017

Primary Completion Date

December 28, 2023

Study Completion Date

May 30, 2024

Conditions
Thrombotic Thrombocytopenic Purpura (TTP)
Interventions
BIOLOGICAL

TAK-755

Participants in prophylaxis cohort will receive IV infusions of 40 IU/kg TAK-755 ORT during Period 1 and Period 2 and switch to TAK-755 SIN during Period 3 for six months once in a week or twice in a week. In On-demand cohort participants will receive daily IV dose of TAK-755.

BIOLOGICAL

Standard of care

Participants will receive Investigator-recommended Standard of care (SoC).

Trial Locations (33)

168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma

1090

AKH - Medizinische Universität Wien, Vienna

3010

Hospital General Universitario de Alicante, Alicante

15006

Complejo Hospitalario Universitario A Coruña, A Coruña

20122

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Milan

20246

Universitaetsklinikum Hamburg-Eppendorf, Hamburg

24127

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII), Bergamo

27710

Duke University Medical Center, Durham

30322

Winship Cancer Institute, Atlanta

37007

Hospital Universitario de Salamanca, Salamanca

41013

Hospital Universitario Virgen del Rocio, Seville

42270

CHU Saint Etienne - Hôpital Nord, Saint-Priest-en-Jarez Cedex

43210

Ohio State Univ College Of Medicine, Columbus

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46026

Hospital Universitari i Politecnic La Fe, Valencia

48903

Hospital de Cruces, Barakaldo

59037

Hopital Claude Huriez - CHU Lille, Lille

73104

University of Oklahoma, Oklahoma City

75015

Hôpital Necker - Enfants Malades, Paris

75019

Hôpital Robert Debré - Paris, Paris

75571

Hôpital Saint-Antoine, Paris

77030

The Methodist Hospital, Houston

89135

Alliance for Childhood Diseases, Cure 4 the Kids Foundation, Las Vegas

90124

"Azienda Ospedaliera Universitaria Policlinico - Vittorio Emanuele (Presidio Ferrarotto Alessi)", Catania

07747

Universitaetsklinikum Jena, Jena

00161

"Dipartimento di Medicina Traslazionale e di Precisione - Sapienza Universita di Roma", Rome

812-8582

Kyushu University Hospital, Fukuoka

663-8501

Hyogo College of Medicine Hospital, Nishinomiya-shi

113-8519

Medical Hospital, Tokyo Medical and Dental University, Bunkyō City

02-091

Samodzielny Publiczny Dzieciecy Szpital Kliniczny, Warsaw

02-776

Instytut Hematologii i Transfuzjologii, Warsaw

NW1 2PG

University College London Hospitals, London

M139WL

Royal Manchester Children's Hospital, Manchester

All Listed Sponsors
collaborator

Takeda Development Center Americas, Inc.

INDUSTRY

lead

Baxalta now part of Shire

INDUSTRY

NCT03393975 - A Study of BAX 930 in Children, Teenagers, and Adults Born With Thrombotic Thrombocytopenic Purpura (TTP) | Biotech Hunter | Biotech Hunter