Trial Condition(s):

Hemophilia A, Hemophilia B

Study of FVIIa variant BAY86-6150 (B0189) in subjects with moderate or severe hemophilia types A or B with or without inhibitors (MATCHBOX)

Bayer Identifier:

13787

ClinicalTrials.gov Identifier:

NCT01921855

EudraCT Number:

2008-000117-29

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
16
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
Yes
Products
BAY86-6150
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Hammersmith Hospital

London, United Kingdom, W12 0HS

Status
Completed
 
Locations

Instytut Hematologii i Transfuzjologii

Warszawa, Poland, 02-776

Status
Completed
 
Locations

University of Witwatersrand

JOHANNESBURG, South Africa, 2193

Status
Completed
 
Locations

University of the Free State

Bloemfontein, South Africa, 9300

Status
Completed
 

Trial Design