NCT01138501 - Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

November 30, 2011

Study Completion Date

November 30, 2011

Conditions

Congenital Bleeding DisorderHaemophilia A

Interventions

DRUG

turoctocog alfa

Subjects will be treated 3 times per week or every second day with intravenous injections of turoctocog alfa. The dose range for preventive treatment is 25-60 IU/kg body weight depending on treatment regimen.

DRUG

turoctocog alfa

Subjects will undergo half-life evaluation of their current factor VIII product and pharmacokinetic session with turoctocog alfa before entering preventive treatment (subjects with available evaluation of terminal half-life within the last year are to be excluded from receiving factor VIII). Intravenous injections. The dose range for preventive treatment is 25-60 IU/kg body weight depending on treatment regimen.

Trial Locations (38)

1000

Novo Nordisk Investigational Site, Skopje

10595

Novo Nordisk Investigational Site, Valhalla

11000

Novo Nordisk Investigational Site, Belgrade

20124

Novo Nordisk Investigational Site, Milan

29425

Novo Nordisk Investigational Site, Charleston

30912

Novo Nordisk Investigational Site, Augusta

33607

Novo Nordisk Investigational Site, Tampa

35100

Novo Nordisk Investigational Site, Bornova-IZMIR

40447

Novo Nordisk Investigational Site, Taipei

41380

Novo Nordisk Investigational Site, İzmit

45404

Novo Nordisk Investigational Site, Dayton

48201

Novo Nordisk Investigational Site, Detroit

48823

Novo Nordisk Investigational Site, East Lansing

50400

Novo Nordisk Investigational Site, Kuala Lumpur

52242

Novo Nordisk Investigational Site, Iowa City

76104

Novo Nordisk Investigational Site, Fort Worth

77030

Novo Nordisk Investigational Site, Houston

92868

Novo Nordisk Investigational Site, Orange

105077

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

90502-2004

Novo Nordisk Investigational Site, Torrance

02115

Novo Nordisk Investigational Site, Boston

64108-4619

Novo Nordisk Investigational Site, Kansas City

68198-2168

Novo Nordisk Investigational Site, Omaha

11201-5425

Novo Nordisk Investigational Site, Brooklyn

97239-3098

Novo Nordisk Investigational Site, Portland

80250-060

Novo Nordisk Investigational Site, Curitiba

20211-030

Novo Nordisk Investigational Site, Rio de Janeiro

05403-000

Novo Nordisk Investigational Site, São Paulo

LT-08406

Novo Nordisk Investigational Site, Vilnius

00-576

Novo Nordisk Investigational Site, Warsaw

50-345

Novo Nordisk Investigational Site, Wroclaw

00935

Novo Nordisk Investigational Site, San Juan

01130

Novo Nordisk Investigational Site, Adana

01010

Novo Nordisk Investigational Site, Antalya