Status:
COMPLETED
Study of FVIIa Variant BAY86-6150 (B0189) in Subjects With Moderate or Severe Hemophilia Types A or B With or Without Inhibitors
Lead Sponsor:
Bayer
Conditions:
Hemophilia A
Hemophilia B
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief Summary
This is the first in humans study of BAY86-6150 (B0189) in non-bleeding subjects with moderate or severe congenital hemophilia A or B with or without inhibitors. This is a randomized, double-blind, pl...
Eligibility Criteria
Inclusion
- History of moderate or severe congenital hemophilia A or B with or without inhibitors to Factor VIII (FVIII) or Factor IX (FIX)
- Male subjects 18-65 years of age inclusive
- Able to dismiss factor replacement therapy during the course of the study unless required for the treatment of an acute bleeding episode
- Written informed consent
- Willing and able to comply with the requirements of the protocol
- Have adequate venous access
- Willing to use an effective method of contraception until Day 30 of their study participation
Exclusion
- Received factor replacement therapy or treatment with any other procoagulant therapeutics, or any antifibrinolytic agents, including blood products, at anytime within 5 days prior to administration of investigational medicinal product (IMP)
- Planned administration of factor replacement therapy or treatment with any other procoagulant therapeutics or any antifibrinolytic agents, including blood products, at anytime during the study period
- Acute bleeding episode or any ongoing bleeding episode at any time within 7 days prior to administration IMP
- Clinically relevant coagulation disorder other than congenital hemophilia A or B
- History of angina or receiving treatment for angina
- History of coronary atherosclerotic disease, disseminated intravascular coagulopathy, or stage 2 hypertension defined as systolic blood pressure (SBP) \>/= 160 mmHg or diastolic blood pressure (DBP) \>/= 90 mmHg
- History of transient ischemic attack, stroke, myocardial infarction, coronary artery disease, congestive heart failure, or thromboembolic event
- Active infection on day of IMP administration or septicemia at any time within 30 days prior to administration of IMP
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01921855
Start Date
January 1 2009
End Date
December 1 2009
Last Update
August 21 2014
Active Locations (4)
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1
Warsaw, Poland, 02-776
2
Bloemfontein, Freestate, South Africa, 9300
3
Johannesburg, Gauteng, South Africa, 2193
4
London, United Kingdom, W12 0HS