A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A

PHASE3CompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

February 20, 2013

Primary Completion Date

September 15, 2014

Study Completion Date

September 28, 2018

Conditions
Congenital Bleeding DisorderHaemophilia A
Interventions
DRUG

turoctocog alfa pegol

Fixed dose of turoctocog alfa pegol for intravenous injections (i.v.) twice weekly for prophylaxis. In addition, turoctocog alfa pegol will be administered to treat bleeding episodes during the trial period. Bleeding episodes will be treated with doses of 20-75 U/kg body weight.

Trial Locations (51)

6000

Novo Nordisk Investigational Site, Lucerne

6500

Novo Nordisk Investigational Site, Bellinzona

8032

Novo Nordisk Investigational Site, Zurich

11040

Novo Nordisk Investigational Site, New Hyde Park

19104

Novo Nordisk Investigational Site, Philadelphia

19134

Novo Nordisk Investigational Site, Philadelphia

22903

Novo Nordisk Investigational Site, Charlottesville

28204

Novo Nordisk Investigational Site, Charlotte

29425

Novo Nordisk Investigational Site, Charleston

32827

Novo Nordisk Investigational Site, Orlando

33607

Novo Nordisk Investigational Site, Tampa

35100

Novo Nordisk Investigational Site, Bornova-IZMIR

36100

Novo Nordisk Investigational Site, Vicenza

41380

Novo Nordisk Investigational Site, İzmit

45229

Novo Nordisk Investigational Site, Cincinnati

45404

Novo Nordisk Investigational Site, Dayton

50400

Novo Nordisk Investigational Site, Kuala Lumpur

52242

Novo Nordisk Investigational Site, Iowa City

52621

Novo Nordisk Investigational Site, Tel Litwinsky

55404

Novo Nordisk Investigational Site, Minneapolis

59097

Novo Nordisk Investigational Site, Lille

69677

Novo Nordisk Investigational Site, Bron

75015

Novo Nordisk Investigational Site, Paris

75235

Novo Nordisk Investigational Site, Dallas

77030

Novo Nordisk Investigational Site, Houston

79044

Novo Nordisk Investigational Site, Lviv

83045

Novo Nordisk Investigational Site, Donetsk

83712

Novo Nordisk Investigational Site, Boise

90806

Novo Nordisk Investigational Site, Long Beach

92868

Novo Nordisk Investigational Site, Orange

99204

Novo Nordisk Investigational Site, Spokane

85016-7710

Novo Nordisk Investigational Site, Phoenix

20010-2978

Novo Nordisk Investigational Site, Washington D.C.

70118-5720

Novo Nordisk Investigational Site, New Orleans

02115

Novo Nordisk Investigational Site, Boston

68198-6828

Novo Nordisk Investigational Site, Omaha

37232-9830

Novo Nordisk Investigational Site, Nashville

20211-030

Novo Nordisk Investigational Site, Rio de Janeiro

M5G 1X8

Novo Nordisk Investigational Site, Toronto

GR-11527

Novo Nordisk Investigational Site, Athens

GR 54642

Novo Nordisk Investigational Site, Thessaloniki

807 8555

Novo Nordisk Investigational Site, Kitakyusyu, Fukuoka

167-0035

Novo Nordisk Investigational Site, Tokyo

LT-08406

Novo Nordisk Investigational Site, Vilnius

4200-319

Novo Nordisk Investigational Site, Porto

00935

Novo Nordisk Investigational Site, San Juan

01010

Novo Nordisk Investigational Site, Antalya

Unknown

Novo Nordisk Investigational Site, Samsun

LE1 5WW

Novo Nordisk Investigational Site, Leicester

SE1 7EH

Novo Nordisk Investigational Site, London

OX3 9DU

Novo Nordisk Investigational Site, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT01731600 - A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A | Biotech Hunter | Biotech Hunter