Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015

PHASE3CompletedINTERVENTIONAL
Enrollment

214

Participants

Timeline

Start Date

October 26, 2009

Primary Completion Date

June 28, 2016

Study Completion Date

June 29, 2016

Conditions
Congenital Bleeding DisorderHaemophilia A
Interventions
DRUG

turoctocog alfa

The preventative treatment is administered intravenously (i.v.) at specific intervals either every second day or three times a week. Bleeding treatment will be administered if a bleed should occur.

DRUG

turoctocog alfa

Treatment is administered intravenously (i.v.) during bleeds and occasionally as a preventative treatment (e.g. before physical activity)

Trial Locations (57)

100

Novo Nordisk Investigational Site, Taipei

1000

Novo Nordisk Investigational Site, Skopje

1006

Novo Nordisk Investigational Site, Riga

8091

Novo Nordisk Investigational Site, Zurich

10249

Novo Nordisk Investigational Site, Berlin

11000

Novo Nordisk Investigational Site, Belgrade

11070

Novo Nordisk Investigational Site, Belgrade

18000

Novo Nordisk Investigational Site, Niš

20124

Novo Nordisk Investigational Site, Milan

21000

Novo Nordisk Investigational Site, Novi Sad

28046

Novo Nordisk Investigational Site, Madrid

30322

Novo Nordisk Investigational Site, Atlanta

30625

Novo Nordisk Investigational Site, Hanover

33607

Novo Nordisk Investigational Site, Tampa

35100

Novo Nordisk Investigational Site, Bornova-IZMIR

35392

Novo Nordisk Investigational Site, Giessen

41380

Novo Nordisk Investigational Site, İzmit

45229

Novo Nordisk Investigational Site, Cincinnati

45404

Novo Nordisk Investigational Site, Dayton

46026

Novo Nordisk Investigational Site, Valencia

50134

Novo Nordisk Investigational Site, Florence

50400

Novo Nordisk Investigational Site, Kuala Lumpur

52242

Novo Nordisk Investigational Site, Iowa City

52621

Novo Nordisk Investigational Site, Tel Litwinsky

53127

Novo Nordisk Investigational Site, Bonn

55319

Novo Nordisk Investigational Site, Samsun

77030

Novo Nordisk Investigational Site, Houston

90806

Novo Nordisk Investigational Site, Long Beach

97239

Novo Nordisk Investigational Site, Portland

99204

Novo Nordisk Investigational Site, Spokane

119049

Novo Nordisk Investigational Site, Moscow

191119

Novo Nordisk Investigational Site, Saint Petersburg

4208660

Novo Nordisk Investigational Site, Shizuoka-shi, Shizuoka

13081970

Novo Nordisk Investigational Site, Campinas

85016-7710

Novo Nordisk Investigational Site, Phoenix

02115

Novo Nordisk Investigational Site, Boston

02903

Novo Nordisk Investigational Site, Providence

37232-9830

Novo Nordisk Investigational Site, Nashville

80250-060

Novo Nordisk Investigational Site, Curitiba

05403-000

Novo Nordisk Investigational Site, São Paulo

20211-030

Novo Nordisk Investigational Site, Rio de Janeiro

21 000

Novo Nordisk Investigational Site, Split

10 000

Novo Nordisk Investigational Site, Zagreb

Unknown

Novo Nordisk Investigational Site, Tel Aviv

634 8522

Novo Nordisk Investigational Site, Kashihara-shi, Nara

466 8560

Novo Nordisk Investigational Site, Nagoya-shi, Aichi

329 0498

Novo Nordisk Investigational Site, Shimotsuke-shi, Tochigi

160 0023

Novo Nordisk Investigational Site, Shinjuku-ku, Tokyo

LT-08406

Novo Nordisk Investigational Site, Vilnius

00-576

Novo Nordisk Investigational Site, Warsaw

50-556

Novo Nordisk Investigational Site, Wroclaw

00935

Novo Nordisk Investigational Site, San Juan

01130

Novo Nordisk Investigational Site, Adana

01010

Novo Nordisk Investigational Site, Antalya

NW3 2QG

Novo Nordisk Investigational Site, London

SE1 7EH

Novo Nordisk Investigational Site, London

M13 9WL

Novo Nordisk Investigational Site, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT00984126 - Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015 | Biotech Hunter | Biotech Hunter