Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study)

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

159

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

July 17, 2014

Study Completion Date

July 17, 2014

Conditions
Hemophilia A
Interventions
BIOLOGICAL

Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method

Pharmacokinetic (PK) evaluation of ADVATE

BIOLOGICAL

PEGylated Recombinant Factor VIII

Pharmacokinetic (PK) evaluation of BAX 855

BIOLOGICAL

PEGylated Recombinant Factor VIII

Prophylaxis treatment

BIOLOGICAL

PEGylated Recombinant Factor VIII

On-demand treatment

Trial Locations (72)

1090

AKH - Medizinische Universität Wien, Vienna

1527

SHAT of Oncohaematology Diseases, Sofia

3168

The Alfred Hospital, Clayton

4020

Landes-Frauen-und Kinderklinik Linz, Linz

5000

Royal Adelaide Hospital, Adelaide

6009

Hollywood Specialist Centre, Nedlands

6160

Fremantle Hospital, Fremantle

8091

Universitatsspital Zurich, Zurich

10065

Weill Cornell Medical College-New York Presbyterian Hospital, New York

10249

Vivantes Klinikum im Friedrichshain - Landsberger Allee, Berlin

10990

Hospital Pulau Pinang, George Town

11490

Tri-Service General Hospital, Taipei

15006

Complejo Hospitalario Universitario A Coruña, A Coruña

17033

Penn State Milton S. Hershey Medical Center, Hershey

17176

Karolinska Universitetssjukhuset, Solna, Stockholm

20246

Universitaetsklinikum Hamburg-Eppendorf, Hamburg

20502

Skånes Universitetssjukhus, Malmö, Malmo

27599

University of North Carolina Chapel Hill, Chapel Hill

27710

Duke University Medical Center, Durham

29010

Hospital Regional Universitario de Malaga, Málaga

29203

Palmetto Health, Columbia

30159

Werlhof-Institut MVZ, Hanover

30322

Children's Healthcare of Atlanta, Atlanta

32610

University of Florida, College of Medicine, Gainesville

40202

University of Louisville Hospital, Louisville

40504

University of Kentucky Medical Center, Lexington

41200

Hospital Tengku Ampuan Rahimah, Klang

44195

The Cleveland Clinic Foundation, Cleveland

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46026

Hospital Universitari i Politecnic La Fe, Valencia

47051

Gerinnungszentrum Rhein-Ruhr, Duisburg

50400

Pusat Darah Negara, Kuala Lumpur

61300

Fakultni nemocnice Brno, Brno

61614

Bleeding and Clotting Disorders Institute, Peoria

64239

Chaim Sheba Medical Center, Tel Aviv

66211

Children's Mercy Hospitals & Clinics, Kansas City

70124

Tulane University Medical School, New Orleans

79044

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

80045

University of Colorado, Aurora

83045

SI V.K.Gusak Emergency and Reconstructive Surgery Institute of NAMSU Center of IT, Donetsk

84132

University of Utah Health Sciences Center, Salt Lake City

98104

Puget Sound Blood Group, Seattle

3109601

Rambam Health Care Campus, Haifa

775 20

Fakultni nemocnice Olomouc, Olomouc

150 06

Fakultni nemocnice v Motole, Prague

466-8560

Nagoya University Hospital, Nagoya

807-8556

University of Occupational and Environmental Health Hospital, Kitakyushu-shi

734-8551

Hiroshima University Hospital, Hiroshima

663-8501

Hyogo College of Medicine Hospital, Nishinomiya-shi

216-8511

St. Marianna University School of Medicine Hospital, Kawasaki-shi

634-8522

Nara Medical University Hospital, Kashihara-shi

160-0023

Tokyo Medical University Hospital, Shinjuku-ku

167-8515

Ogikubo Hospital, Suginami-ku

08661

Vilnius University Hospital Santariskiu Clinics, Public Institution, Vilnius

LT-08406

Children's Hospital, Affiliate of Vilnius University Hospital Santariskiu Klinikos, Vilnius

1105 AZ

Academisch Medisch Centrum, Amsterdam

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

93-510

Wojewodzki Szpital Specjalistyczny im.M.Kopernika w Lodzi, Lodz

011026

Sanador SRL, Bucharest

519-763

Chonnam National University Hwasun Hospital, Hwasun

602-739

Pusan National University Hospital, Busan

302-120

Eulji University Hospital, Daejeon

134-727

Kyung hee University Hospital at Gangdong, Seoul

682-714

Ulsan University Hospital, Ulsan

07010

Hospital Universitari Son Espases, Palma de Mallorca

BS2 8BJ

Bristol Royal Hospital for Children, Bristol

NW3 2QG

Royal Free Hospital, London

SE1 7EH

St Thomas' Hospital, London

M13 9WL

Manchester Royal Infirmary, Manchester

Royal Manchester Children's Hospital, Manchester

LE1 5WW

Leicester Royal Infirmary, Leicester

OX3 7LJ

Churchill Hospital, Oxford

All Listed Sponsors
lead

Baxalta now part of Shire

INDUSTRY

NCT01736475 - Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study) | Biotech Hunter | Biotech Hunter