Study of FVIIa Variant BAY86-6150 (B0189) in Subjects With Moderate or Severe Hemophilia Types A or B With or Without Inhibitors

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer

Criteria

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 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