NCT01625390 - A Phase 2/ 3 Trial to Evaluate the Efficacy and Safety of BAY86-6150 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

March 31, 2014

Study Completion Date

March 31, 2014

Conditions

Hemophilia A, Hemophilia B

Interventions

DRUG

BAY86-6150

Four dose levels (6.5 µg/kg, 20 µg/kg, 50 µg/kg and 90 µg/kg) of BAY86-6150 will be studied.

DRUG

eptacog alfa [activated]

comparative PK/PD (pharmacokinetics/pharmacodynamics) evaluation

DRUG

BAY86-6150

Confirmation of recommended dose of BAY86-6150 to be evaluated further as determined in Part A.

Trial Locations (61)

34

Bangalore

110

Taipei

500

Changhua

1134

Budapest

1756

Sofia

2132

Johannesburg

4032

Debrecen

8011

Christchurch

8200

Aarhus N

10016

Taipei

11026

Bucharest

20122

Milan

34098

Istanbul

35100

Izmir

37044

Tours

37403

Chattanooga

50134

Florence

55131

Mainz

65025

Odesa

68000

Oaxaca City

69437

Lyon

78050

Villingen-Schwenningen

78216

San Luis Potosí City

79044

Lviv

83045

Donetsk

95817

Sacramento

100730

Beijing

119228

Singapore

141008

Ludhiana

169608

Singapore

191186

Saint Petersburg

300011

Timișoara

411004

Pune

443079

Samara

500034

Hyderabad

510515

Guangzhou

620149

Yekaterinburg

680009

Khabarovsk

5262000

Tel Litwinsky

20211030

Rio de Janeiro

Unknown

Melbourne

Tianjin

Barranquilla

Bogotá

Guadalajara

Bloemfontein

01401901

São Paulo

04023-061

São Paulo

836-0156

Santiago

634-8522

Kashihara

160-0023

Shinjuku-ku

167-0035

Suginami

04530

México D. F.

3508 GA

Utrecht

02-776

Warsaw

022328

Bucharest

0001

Pretoria

134-727

Seoul

413 45

Gothenburg

SE1 7EH

London

TR1 3LJ

Truro