Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor (rVWF) in the Treatment of Bleeding Episodes in Von Willebrand Disease (VWD)

PHASE3CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

November 1, 2011

Primary Completion Date

February 1, 2014

Study Completion Date

February 1, 2014

Conditions
Von Willebrand Disease
Interventions
BIOLOGICAL

Recombinant von Willebrand factor (rVWF)

Intravenous administration

DRUG

Placebo

Syringe supplied with physiologic saline solution for infusion

BIOLOGICAL

Recombinant factor VIIII (rFVIII)

Intravenous administration

Trial Locations (52)

1090

Medical University Vienna, Vienna

1200

Cliniques Universitaires Saint-Luc, Brussels

1233

"Specialized Haematological Hospital Joan Pavel", Sofia

3000

UZ Leuven, Leuven

5000

Royal Adelaide Hospital, Adelaide

6847

Royal Perth Hospital, Perth

9010

"Multiprofile Hospital for Active Treatment Sveta Marina", Varna

10249

Vivantes Klinikum im Friedrichshain, Berlin

14621

The Mary M Gooley Hemophilia Center and Rochester General Hospital, Rochester

15006

Hospital Materno Infantil Teresa Herrera, A Coruña

15213

Hemophilia Center of Western Pennsylvania, Pittsburgh

19104

Pennsylvania Hospital, Philadelphia

20122

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan

27599

University of North Carolina at Chapel Hill, Chapel Hill

28046

Hospital Universitario La Paz, Madrid

33101

University of Miami Miller School of Medicine, Miami

35128

Azienda Ospedaliera di Padova, Padua

36100

Ospedale San Bortolo, Vicenza

39008

Hospital Universitario Marques de Valdecilla, Santander

41345

Sahlgrenska Universitetssjukhuset, Gothenburg

46260

Indiana Hemophilia and Thrombosis Center, Indianapolis

47051

Gerinnungszentrum Rhein-Ruhr, Duisburg

50134

Azienda Ospedaliera Universitaria Careggi, Florence

53226

Blood Center of Wisconsin, Milwaukee

55131

Universitätsmedizin der Johannes Gutenberg Universität Mainz, Mainz

61614

University of Illinois College of Medicine at Peoria, Peoria

95817

University of California Davis Cancer Center, Sacramento

195213

Municipal Policlinic # 37, Saint Petersburg

411001

Jehangir Clinical Development Centre Pvt. Ltd., Pune

411004

Sahyadri Speciality Hospital, Pune

610027

Kirov Hematology and Blood Transfusion Research Institute under the Federal Medical and Biological Agency of Russia, Kirov

620149

Regional Pediatric Clinical Hospital #1, Yekaterinburg

632004

Christian Medical College, Vellore

660022

Territorial Clinical Hospital, Krasnoyarsk

1600023

Tokyo Medical University Hospital, Tokyo

4668560

Nagoya University Hospital, Nagoya

07112

Newark Beth Israel Medical Center, Newark

T6G 2H7

University of Alberta Hospital, Edmonton

00161

"Università degli Studi di Roma La Sapienza", Roma

167-0035

Ogikubo Hospital, Tokyo

3015 CE

Erasmus MC, Rotterdam

3584 CX

UMC Utrecht, Utrecht

80-952

Hematology and Transplantology Clinic, University Clinic Centre - Medical University Hospital, Gdansk

31-501

Nicolaus Copernicus Provincial Specialist Hospital in Lodz Department of Hematology, Krakow

02-776

Institute of Haematology and Transfusion Medicine, Warsaw

50-367

Independent Public Clinical Hospital No. 1 in Wroclaw, Department of Hematology, blood cancer and Bone Marrow Transplantation, Wroclaw

07014

Hospital Universitario La Paz, Palma de Mallorca

Unknown

Skåne University Hospital (SUS), Malmo

E1 1BB

The Royal London Hospital, London

NW3 2QG

Royal Free Hospital, London

W12 0NN

Hammersmith Hospital, London

M13 9WL

Manchester Royal Infirmary, Manchester

All Listed Sponsors
lead

Baxalta now part of Shire

INDUSTRY

NCT01410227 - Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor (rVWF) in the Treatment of Bleeding Episodes in Von Willebrand Disease (VWD) | Biotech Hunter | Biotech Hunter