Study of FVIIa Variant BAY86-6150 (B0189) in Subjects With Moderate or Severe Hemophilia Types A … (NCT01921855) | Clinical Trial Compass
CompletedPhase 1
Study of FVIIa Variant BAY86-6150 (B0189) in Subjects With Moderate or Severe Hemophilia Types A or B With or Without Inhibitors
Poland, South Africa, United Kingdom16 participantsStarted 2009-01
Plain-language 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, placebo-controlled, single-dose, dose escalation study. It is designed to investigate the safety, tolerability, potential immunogenicity, pharmacokinetic and pharmacodynamic profile of BAY86-6150 (B0189) and to determine a dose or range of doses to be examined in subsequent studies.
Who can participate
Age range18 Years – 65 Years
SexMALE
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Inclusion Criteria:
* 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 Criteria:
* 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 tra…
What they're measuring
1
Number of participants with adverse events as a measure of safety and tolerability