BAX 855 PK-guided Dosing

PHASE3CompletedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

November 23, 2015

Primary Completion Date

August 5, 2018

Study Completion Date

August 5, 2018

Conditions
Hemophilia A
Interventions
BIOLOGICAL

PEGylated Recombinant Factor VIII

Pharmacokinetic (PK) evaluation

BIOLOGICAL

PEGylated Recombinant Factor VIII

Standard treatment

BIOLOGICAL

PEGylated Recombinant Factor VIII

Intensified treatment

Trial Locations (83)

1090

AKH - Medizinische Universität Wien, Vienna

1134

Magyar Honvedseg EK, Budapest

1135

NChSH Okhmatdyt of MoHU Center of Children Oncohematology and Bone Marrow Transplantation, Kyiv

1527

UMHAT 'Tsaritsa Yoanna - ISUL', EAD, Sofia

4002

"UMHAT Sv. Georgi, EAD", Plovdiv

4006

Royal Brisbane Women's Hospital, Herston

4032

DE OEC Belgyógyászati Int, Debrecen

4112

Kyiv CCH #9 Dept of Surgery City SPC of Diagnostics & Treatment of Patients with HP, Kyiv

6009

The Perth Blood Institute, Nedlands

7624

PTE ÁOK, Pécs

8091

Universitätsspital Zürich, Zurich

9010

MHAT 'Sv. Marina', EAD, Clinic of Clinical Hematology, Varna

10126

AOU Citta della Salute e della Scienza - Presidio Molinette, Torino

10249

Hamophiliezentrum/Gerinnungssprechstunde, Berlin

10450

Hospital Pulau Pinang, Pulau Pinang

11490

Tri-Service General Hospital, Taipei

14003

CHU de Caen - Hôpital Côte de Nacre, Caen

15006

Complejo Hospitalario Universitario A Coruña, A Coruña

17176

Karolinska Universitetssjukhuset, Stockholm

20122

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

28046

Hospital Universitario La Paz, Madrid

29010

Hospital Regional Universitario de Malaga, Málaga

29609

Hôpital Morvan, Brest

30322

Emory University-ECC, Atlanta

31033

UOC Ematologia, Azienda ULSS 8 Asolo, Regione Veneto, Castelfranco Veneto

32610

University of Florida College of Medicine, Gainesville

34098

Istanbul University, Istanbul

35033

CHU Rennes - Hopital Pontchaillou, Rennes

35040

Ege University, Izmir

36011

M.V. Sklifosovskyi Poltava RCH Dept of Gematology HSEIU Ukrainian Medical Stomatological Academy, Poltava

36100

"ULSS n. 6 Vicenza", Vicenza

40202

University of Louisville KCPCRU, Louisville

40447

China Medical University Hospital, Taichung

40504

University of Kentucky Medical Center, Lexington

40705

Taichung Veterans General Hospital, Taichung

47051

COAGULATION RESEARCH CENTRE GmbH, Duisburg

50586

Hospital Kuala Lumpur, Kuala Lumpur

53127

Inst. f. Experimentelle Hamatologie u. Transfusionsmedizin, Bonn

65446

HZRM Hamophilie Zentrum Rhein Main GmbH, Mörfelden-Walldorf

68000

Hospital Ampang, Ampang

70112

Tulane University, New Orleans

75400

Hospital Melaka, Malacca

76031

CHU Charles Nicolle, Rouen

77030

Gulf States Hemophilia Centre, Houston

79044

SI Institute of Blood Pathology and Transfusion Medicine of NAMSU, Lviv

80045

University of Colorado, Aurora

84132

University of Utah, Salt Lake City

85724

Arizona Hemophilia & Thrombosis Center, located within The University of Arizona Cancer Center, Tucson

88586

Hospital Queen Elizabeth, Kota Kinabalu

90027

Children's Hospital Los Angeles, Los Angeles

90124

Presidio Osped. Ferrarotto, Catania

98104

University of Washington, Seattle

119074

National University Hospital, Singapore

169608

Singapore General Hospital- Parent, Singapore

229899

KK Women's And Children's Hospital, Singapore

400124

Institutul Oncologic ClNa., Cluj-Napoca

500365

Spitalul Clinic Judetean de Urgenta Brasov, Brasov

5262000

Chaim Sheba Medical Center, Tel Litwinsky

85016-7710

Phoenix Childrens Hospital, Phoenix

02115

Boston Children's Hospital, Boston

68198-5456

University of Nebraska Medical Center, Omaha

06200

CHU Nice- Service hematologie, Nice

04289

MVZ Labor Dr. Reising-Ackermann, Leipzig

Unknown

University of Hong Kong, Hong Kong

00000

Prince of Wales Hospital, Shatin

00144

Umberto I Pol. di Roma-Università di Roma La Sapienza, Roma

00168

Fondazione Policlinico Universitario A. Gemelli, Roma

0372

Oslo Universitetssykehus HF, Oslo

93-510

Wojewodzki Szpital Specjalistyczny im. Mikolaja Kopernika, Klinika Hematologii, Lodz

61-828

Alvamed, Poznan

02-776

Instytut Hematologii Ii Transfuzjologii, Warsaw

50-367

SP Szpital Kliniczny Nr 1 we Wroclawiu, Wroclaw

07010

Hospital Universitari Son Espases, Palma de Mallorca

S-41345

Sahlgrenska Universitetssjukhuset, Gothenburg

01130

Acibadem Hastanesi, Adana

07070

Akdeniz University, Antalya

BS2 8BJ

Bristol Royal Hospital for Children, Bristol

NW3 2QG

Royal Free Hospital, London

M13 9WL

Royal Manchester Children's Hospital, Manchester

SO16 6YD

Southampton General Hospital, Southampton

LE1 5WW

Leicester Royal Infirmary, Leicester

OX3 7LJ

Churchill Hospital, Oxford

CF14 4XN

University Hospital of Wales, Cardiff

All Listed Sponsors
collaborator

Baxalta Innovations GmbH, now part of Shire

INDUSTRY

lead

Baxalta now part of Shire

INDUSTRY

NCT02585960 - BAX 855 PK-guided Dosing | Biotech Hunter | Biotech Hunter