Trial Condition(s):

Hemophilia A

A trial investigating safety and efficacy of treatment with BAY94-9027 in severe Hemophilia A (PROTECT-VIII)

Bayer Identifier:

13024

ClinicalTrials.gov Identifier:

NCT01580293

EudraCT Number:

2011-005210-11

Study Completed

Trial Purpose

Haemophilia A is an inherited disorder in which one of the proteins, Factor VIII, needed to form blood clots is missing or not present in sufficient levels. In a person with haemophilia A, the clotting process is slowed and the person experiences bleeds that can result in serious problems and potential disability.
The current standard treatment for severe haemophilia A is regularly scheduled infusion of FVIII to keep levels high enough to prevent bleeding. Due to the short half-life of FVIII, prophylaxis may require treatment as often as every other day.
In this trial safety and efficacy of a long-acting recombinant factor VIII molecule is evaluated in subjects with severe Hemophilia A.
120-140 patients will receive open label treatment with long-acting rFVIII either on-demand to treat bleeds or prophylactically for 36 weeks in the main trial plus an optional extension to continue treatment for at least 100 total exposure days (ED). Patients on prophylactic treatment will receive study drug at dosing intervals between once and twice a week depending on their observed bleeding. Patients will attend the treatment centre for routine blood samples and be required to keep an electronic diary.
Male patients aged 12-65, with severe hemophilia A, previously treated with FVIII for at least 50 exposure days may be eligible for this study.

Inclusion Criteria
- Male; 12-65 years of age 
- Subjects with severe hemophilia A
- Previously treated with factor VIII for a minimum of 150 exposure days
Exclusion Criteria
- Inhibitors to FVIII (current evidence or history) 
- Any other inherited or acquired bleeding disorder in addition to Hemophilia A 
- Platelet count < 100,000/mm3
- Creatinine > 2x upper limit of normal or AST/ALT (aspartate aminotransferase/alanine aminotransferase) > 5x upper limit of normal

Trial Summary

Enrollment Goal
145
Trial Dates
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Phase
2/3
Could I receive a placebo?
No
Products
Jivi (Damoctocog, BAY94-9027)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Wien, Austria, 1090

Status
Completed
 
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Investigative Site

Ramat Gan, Israel, 5262000

Status
Completed
 
Locations

Investigative Site

Cleveland, United States, 44106-6007

Status
Completed
 
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Investigative Site

Sheffield, United Kingdom, S10 2JF

Status
Completed
 
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Investigative Site

London, United Kingdom, SE1 7EH

Status
Completed
 
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Investigative Site

Newcastle Upon Tyne, United Kingdom, NE1 4LP

Status
Completed
 
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Oslo, Norway, 0372

Status
Completed
 
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Hershey, United States, 17033

Status
Completed
 
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Singapore, Singapore, 169608

Status
Completed
 
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Singapore, Singapore, 119228

Status
Completed
 
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Investigative Site

Singapore, Singapore, 229 899

Status
Completed
 
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Investigative Site

Wroclaw, Poland, 50-367

Status
Completed
 
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Columbus, United States, 43205

Status
Completed
 
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Jacksonville, United States, 32207

Status
Completed
 
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Miami, United States, 33136

Status
Completed
 
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Investigative Site

MARSEILLE, France, 13005

Status
Completed
 
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RENNES CEDEX, France, 35033

Status
Completed
 
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Investigative Site

BRUGGE, Belgium, 8000

Status
Completed
 
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Groningen, Netherlands, 9713 GZ

Status
Completed
 
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AMSTERDAM, Netherlands, 1105 AZ

Status
Completed
 
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Aarhus N, Denmark, 8200

Status
Completed
 
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Bonn, Germany, 53127

Status
Completed
 
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Heidelberg, Germany, 69004

Status
Completed
 
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Syracuse, United States, 13210

Status
Completed
 
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Detroit, United States, 48202

Status
Completed
 
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Seoul, South Korea, 05278

Status
Completed
 
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Daejeon, South Korea, 35233

Status
Completed
 
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Busan, South Korea, 49241

Status
Completed
 
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Seoul, South Korea, 03722

Status
Completed
 
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Richmond, United States, 23298-0155

Status
Completed
 
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Investigative Site

Chicago, United States, 60612

Status
Completed
 
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London, Canada, N6A 5W9

Status
Completed
 
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Minneapolis, United States, 55455

Status
Completed
 
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Cincinnati, United States, 45229-3039

Status
Completed
 
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BRON cedex, France, 69677

Status
Completed
 
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REIMS CEDEX, France, 51092

Status
Completed
 
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Napoli, Italy, 80131

Status
Completed
 
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Milano, Italy, 20122

Status
Completed
 
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Roma, Italy, 00161

Status
Completed
 
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Torino, Italy, 10126

Status
Completed
 
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MAASTRICHT, Netherlands, 6229 HX

Status
Completed
 
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Izmir, Turkey, 35100

Status
Completed
 
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Ankara, Turkey, 06100

Status
Completed
 
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Barranquilla, Colombia

Status
Completed
 
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Medellín, Colombia

Status
Completed
 
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Taipei, Taiwan, China, 10002

Status
Completed
 
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Taipei, Taiwan, China, 11217

Status
Completed
 
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Investigative Site

Changhua, Taiwan, China, 50006

Status
Completed
 
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Sacramento, United States, 95817

Status
Completed
 
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Investigative Site

San Diego, United States, 92103-8651

Status
Completed
 
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Investigative Site

DEN HAAG, Netherlands, 2545 CH

Status
Completed
 
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Investigative Site

Hiroshima, Japan, 734-8551

Status
Completed
 
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Investigative Site

Nishinomiya, Japan, 663-8501

Status
Completed
 
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Investigative Site

Nagoya, Japan, 466-8560

Status
Completed
 
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Investigative Site

Suginami, Japan, 167-0035

Status
Completed
 
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Investigative Site

Shinjuku-ku, Japan, 160-0023

Status
Completed
 
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Investigative Site

Kashihara, Japan, 634-8522

Status
Completed
 
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Investigative Site

Tucson, United States, 85724-5024

Status
Completed
 
Locations

Investigative Site

Timisoara, Romania, 300011

Status
Completed
 

Trial Design