A Study of PEGylated Recombinant Factor VIII (BAX855) in Previously Untreated Young Children With Severe Hemophilia A

PHASE3CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

November 12, 2015

Primary Completion Date

October 29, 2024

Study Completion Date

October 29, 2024

Conditions
Hemophilia A
Interventions
BIOLOGICAL

PEGylated Recombinant Factor VIII

Polyethylene glycol (PEG)-ylated full-length recombinant FVIII (rFVIII).

BIOLOGICAL

ITI

Immune tolerance induction therapy

Trial Locations (91)

1020

HUDERF, Brussels

1086

Belgyogyaszat Onkohaematologia, Budapest

1090

Medizinische Universitat Wien, Vienna

1130

Acibadem Adana Hospital, Adana

1200

Cliniques Uni Saint-Luc, Brussels

1527

SHAT Oncohaematology Diseases, Sofia

2100

Rigshospitalet Copenhagen, Copenhagen

3000

Universitair Ziekenhuis Leuven, Leuven

4000

UMHAT Sv. Georgi, EAD, Plovdiv

4032

Debreceni Egyetem, Debrece

7058

Akdeniz Universitesi, Antalya

9000

Univ. Ziekenhuis Gent Apotheek, Ghent

9010

MHAT Sv. Marina, EAD, Varna

10065

New York Presbyterian Hospital, New York

10330

King Chulalongkorn Memorial, Patumwan

10400

Ramathibodi Hospital, Ratchathewi

10700

Siriraj Hospital, Bangkoknoi

10990

Hospital Pulau Pinang, George Town

11490

Tri-Service General Hospital, Taipei

14033

CHU CAEN Hopital Cote de Nacre, Caen

15006

HOSPITAL A Coruna, A Coruña

16059

Uludag Universitesi Tip Fakültesi, Bursa

18009

MI Cherkasy Reg Onc Dis of CRC, Cherkasy

20122

Ospedale Maggiore Policlinico, Milan

20246

Poliklinik PaediaHaematologie, Hamburg

20400

Hospital Sultanah Nur Zahirah, Terengganu

27157

Wake Forest Baptist Medical Center, Winston-Salem

28046

Hospital Universitario La Paz, Madrid

28204

Novant Health Presbyterian Medical Center, Charlotte

30159

Werlhof-Institut GmbH, Hanover

30322

Center for Advanced Pediatrics, Atlanta

30990

Hospital HRPB, Ipoh

34098

Istanbul Üniversitesi Cerrahpaşa, Istanbul

35033

Essais cliniques CHU Rennes, Rennes

35040

Ege Universitesi Tip Fakultesi, Izmir

35233

Eulji University Hospital, Daejeon

38039

Erciyes Univers Tip Fakultesi, Kayseri

40002

Srinagarind Hospital, Muang

40225

Klinik F.Haematologie,Onkologie, Düsseldorf

40447

China Medical University Hospital, Taichung

40705

Taichung Veterans General, Taichung

44033

Ulsan University Hospital, Ulsan

44106

Rainbow Babies/Childrens Htl, Cleveland

47012

Hospital Univ del Rio Hortega, Valladolid

50134

Azienda Ospedaliera Universitaria Careggi, Florence

50200

Maharaj Nakorn Chiang Mai, Muang

50586

Hospital Kuala Lumpur, Kuala Lumpur

53127

Inst. f. Experimentelle, Bonn

55319

19 Mayis Universitesi, Samsun

59037

Hopital Jeanne de Flandre - CHU Lille, Lille

61615

Bleeding and Clotting Dis.Inst., Peoria

68000

Hospital Ampang, Ampang

69063

CI Zaporizhzhia Reg CCH of ZRC, Zaporizhzhia

75743

Hopital Necker Enfants Malades, Paris

76031

CHU de Rouen, Rouen

77030

Texas Children's Hospital, Houston

79044

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

79905

Texas Tech University Health Sciences Center, El Paso

80756

Kaohsiung Chung- Ho Memorial Hosp, Kaohsiung City

84113

Primary Children's Hospital, Salt Lake City

85016

Phoenix Childrens Hospital, Phoenix

93586

Hospital Umum Sarawak, Kuching

94611

Kaiser Permanente Oakland M.C., Oakland

95014

Kaiser Permanente Oakland M.C., Cupertino

95124

Presidio Ospedaliero F. Alessi, Catania

95661

Kaiser Permanente Oakland M.C., Roseville

95817

UC Davis Health System, Sacramento

117599

NUS YLL School of Medicine, Singapore

229899

KKH, Singapore

06106

Connecticut Children's Med Ctr, Hartford

17033-0850

Univ Florida College Medicine, Gainesville

Penn State MS Hershey Med Ctr, Hershey

60611-2605

Ann & Robert H. Lurie Children's H, Chicago

48109-5008

UMHS, Ann Arbor

45229-3039

Cincinnati Children's Hospital, Cincinnati

T6G 1Z1

Kaye Edmonton Clinic, Edmonton

L8N 3Z5

McMaster Health Science, Hamilton

00290

Helsinki Univ Hospital, Helsinki

Unknown

The University of Hong Kong Queen Mary Hospital, Hong Kong

Chinese University Of Hong Kong, Shatin

00144

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

9713 GZ

Universitair Medisch Centrum Groningen (UMCG), Groningen

N-0372

Oslo Universitetssykehus - Rikshospitalet, Oslo

03722

Severance Hospital, Yonsei, Seoul

05278

Kyung Hee University Hospital, Seoul

07120

Hospital Univ. Son Espases, Palma de Mallorca

06100

Hacettepe Üniversitesi, Ankara

M13 9WL

Royal Manchester Children's Hospital, Manchester

SO16 6YD

Univ Hospital Southampton, Southampton

BS2 8AE

Bristol Royal H. for Children, Bristol

SE1 7EH

Evelina Children's Hospital - St Thomas' Hospital, London

All Listed Sponsors
collaborator

Takeda Development Center Americas, Inc.

INDUSTRY

lead

Baxalta now part of Shire

INDUSTRY

NCT02615691 - A Study of PEGylated Recombinant Factor VIII (BAX855) in Previously Untreated Young Children With Severe Hemophilia A | Biotech Hunter | Biotech Hunter