Safety and Efficacy of BAY94-9027 in Previously Treated Male Children With Haemophilia A

PHASE3CompletedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

May 29, 2013

Primary Completion Date

March 19, 2015

Study Completion Date

February 19, 2020

Conditions
Hemophilia A
Interventions
BIOLOGICAL

BAY94-9027

Study drug dosing was adjusted to the clinical needs of each subject in the range of 25-60 IU/kg/administration, intravenous infusion, at least 50 EDs and a minimum of at least 6 months

BIOLOGICAL

BAY94-9027

Twice per week prophylaxis: 25-60 IU/kg, intravenous infusion, for 12 weeks

BIOLOGICAL

BAY94-9027

Study drug dosing was adjusted to the clinical needs of each subject in the range of 25-60 IU/kg/administration, intravenous infusion, at least 50 additional EDs to achieve at least 100 cumulative EDs, or until marketing authorization of the drug

Trial Locations (37)

1090

Vienna

1527

Sofia

1900

La Plata

3000

Leuven

3204

Hamilton

4002

Plovdiv

8011

Christchurch

9000

Ghent

9010

Varna

17033

Hershey

20122

Milan

32504

Pensacola

35128

Padua

45229

Cincinnati

54642

Thessaloniki

84113

Salt Lake City

90127

Palermo

95817

Sacramento

300011

Timișoara

5262000

Ramat Gan

44106-6007

Cleveland

43205-2696

Columbus

T3B 6A8

Calgary

M5G 1X8

Toronto

08661

Vilnius

Unknown

Amsterdam

3584 CX

Utrecht

0027

Oslo

91-738

Lodz

10-561

Olsztyn

011026

Bucharest

022328

Bucharest

08950

Esplugues de Llobregat

NE1 4LP

Newcastle upon Tyne

BS2 8AE

Bristol

M13 9WL

Manchester

S10 2TH

Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT01775618 - Safety and Efficacy of BAY94-9027 in Previously Treated Male Children With Haemophilia A | Biotech Hunter | Biotech Hunter