Trial Condition(s):

Hemophilia A

A trial to compare prophylaxis therapy to on-demand therapy with a new full length recombinant FVIII in patients with severe Hemophilia A (Leopold II)

Bayer Identifier:

14319

ClinicalTrials.gov Identifier:

NCT01233258

EudraCT Number:

2009-012150-20

Study Completed

Trial Purpose

The objective of the trial is to demonstrate that 2-3 times per week prophylaxis therapy with BAY81-8973 is superior to on-demand therapy with BAY81-8973 in patients with severe Hemophilia A. The hypothesis is that prophylaxis will result in fewer bleeds than on-demand treatment.

Inclusion Criteria
- Male, aged 12 to 65 years
 - Severe hemophilia A
 - History of more than 150 exposure days (ED) with clotting factor concentrates
 - Currently receiving episodic treatment with FVIII; no regular prophylaxis for more than 6 consecutive months in the past 5 years
 - No current Factor VIII inhibitor or history of inhibitor
 - Willing to use electronic patient diary
Exclusion Criteria
- Presence of another bleeding disease that is different from hemophilia A 
 - Thrombocytopenia 
 - Abnormal renal function 
 - Presence of active liver disease
 - Known hypersensitivity to FVIII

Trial Summary

Enrollment Goal
80
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Dayton, United States, 45404

Status
Completed
 
Locations

Investigative Site

Shinjuku-ku, Japan, 160-0023

Status
Completed
 
Locations

Investigative Site

Suginami, Japan, 167-0035

Status
Completed
 
Locations

Investigative Site

Kashihara, Japan, 634-8522

Status
Completed
 
Locations

Investigative Site

Nishinomiya, Japan, 663-8501

Status
Terminated
 
Locations

Investigative Site

Hiroshima, Japan, 734-8551

Status
Completed
 
Locations

Investigative Site

San Luis Potosí, Mexico, 78200

Status
Completed
 
Locations

Investigative Site

Guadalajara, Mexico, 44280

Status
Completed
 
Locations

Investigative Site

Johannesburg, South Africa, 2193

Status
Completed
 
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Investigative Site

Pretoria, South Africa, 0001

Status
Completed
 
Locations

Investigative Site

Buenos Aires, Argentina, C1221ADC

Status
Terminated
 
Locations

Investigative Site

Corrientes, Argentina, W3410AVV

Status
Terminated
 
Locations

Investigative Site

Yekaterinburg, Russia, 620149

Status
Completed
 
Locations

Investigative Site

St. Petersburg, Russia, 191186

Status
Completed
 
Locations

Investigative Site

Barnaul, Russia, 656050

Status
Terminated
 
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Investigative Site

Bratislava, Slovakia, 851 07

Status
Terminated
 
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Investigative Site

Jakarta, Indonesia, 10430

Status
Terminated
 
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Investigative Site

Hyderabad, India, 500034

Status
Terminated
 
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Investigative Site

Taichung, Taiwan, China, 40447

Status
Completed
 
Locations

Investigative Site

Taipei, Taiwan, China, 11217

Status
Terminated
 
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Investigative Site

Bangkok, Thailand, 10700

Status
Terminated
 
Locations

Investigative Site

Bangkok, Thailand, 10400

Status
Terminated
 
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Investigative Site

Houston, United States, 77030

Status
Completed
 
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Investigative Site

Olomouc, Czech Republic, 77520

Status
Completed
 
Locations

Investigative Site

Khabarovsk, Russia, 680009

Status
Terminated
 
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Investigative Site

Izmir, Turkey, 35-100

Status
Completed
 
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Investigative Site

Adana, Turkey, 01330

Status
Completed
 
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Investigative Site

Antalya, Turkey, 07059

Status
Completed
 
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Investigative Site

Beograd, Serbia, 11000

Status
Completed
 
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Investigative Site

Nis, Serbia, 18000

Status
Completed
 
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Investigative Site

Timisoara, Romania, 300011

Status
Completed
 
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Investigative Site

Bucharest, Romania, 011026

Status
Completed
 
Locations

Investigative Site

Bucharest, Romania, 022328

Status
Completed
 
Locations

Investigative Site

Baia Mare, Romania, 430031

Status
Completed
 
Locations

Investigative Site

Rosario, Argentina, S2000CKF

Status
Terminated
 
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Investigative Site

Lviv, Ukraine, 79044

Status
Terminated
 
Locations

Investigative Site

Simferopol, Ukraine, 95023

Status
Terminated
 
Locations

Investigative Site

Kiev, Ukraine

Status
Terminated
 
Locations

Investigative Site

Nis, Serbia, 18000

Status
Terminated
 
Locations

Investigative Site

Novi Sad, Serbia, 21000

Status
Completed
 
Locations

Investigative Site

Kragujevac, Serbia, 34000

Status
Completed
 
Locations

Investigative Site

Beograd, Serbia, 11000

Status
Terminated
 
Locations

Investigative Site

Beijing, China, 100730

Status
Completed
 
Locations

Investigative Site

Tianjin, China, 300020

Status
Completed
 
Locations

Investigative Site

Shanghai, China, 200025

Status
Completed
 
Locations

Investigative Site

Suzhou, China, 215006

Status
Completed
 
Locations

Investigative Site

Guangzhou, China, 510515

Status
Completed
 
Locations

Investigative Site

Bogotá, Colombia

Status
Terminated
 
Locations

Investigative Site

Bucaramanga, Colombia

Status
Terminated
 

Trial Design