Study Completed

Hemophilia A, Hemophilia B

Bayer Identifier:

13787

ClinicalTrials.gov Identifier:

NCT01921855

EudraCT Number:

2008-000117-29

EU CT Number:

Not Available

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

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.

Key Participants Requirements

Sex

Male

Age

18 - 65 Years

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

Trial Dates

January 2009 - December 2009

Phase

Phase 1

Could I Receive a placebo

Yes

Products

BAY86-6150

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Hammersmith Hospital	London, W12 0HS, United Kingdom
Completed	Instytut Hematologii i Transfuzjologii	Warszawa, 02-776, Poland
Completed	University of Witwatersrand	JOHANNESBURG, 2193, South Africa
Completed	University of the Free State	Bloemfontein, 9300, South Africa

Primary Outcome

Number of participants with adverse events as a measure of safety and tolerability
Time Frame:
Up to Day 50
Safety Issue:
Yes

Secondary Outcome

Pharmacokinetic assessment, based on plasma concentration of BAY86-6150
Time Frame:
9 time points from pre-dosing on Day 1 up to 48 hours post-dosing
Safety Issue:
No
Pharmacodynamic assessment, based on plasma hemostasis marker level
Time Frame:
9 time points from pre-dosing on Day 1 up to 48 hours post-dosing
Safety Issue:
No
Immunogenicity assessment, based on anti-BAY86-6150 binding antibody levels
Time Frame:
3 time points from pre-dosing on Day 1 up to Day 50
Safety Issue:
Yes

Trial design

A Phase I, randomized, double-blind, placebo controlled, single dose escalation study of FVIIa variant BAY86-6150 (B0189) in subjects with moderate or severe hemophilia types A or B with or without inhibitors

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Factorial Assignment

Trial Arms

Additional Information

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