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

Hemophilia A Clinical Trial

— MATCHBOX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01921855
• Other study ID #: 13787
• Secondary ID: 2008-000117-29
• Status: Completed
• Phase: Phase 1
• First received: July 10, 2013
• Last updated: August 20, 2014
• Start date: January 2009
• Est. completion date: December 2009

Study information

• Verified date: August 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control CouncilUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemophilia A
• Hemophilia B

Intervention

Drug:
• BAY Factor VII (BAY86-6150)
BAY Factor VII (BAY86-6150), 6.5 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.
• BAY Factor VII (BAY86-6150)
BAY Factor VII (BAY86-6150), 20 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.
• BAY Factor VII (BAY86-6150)
BAY Factor VII (BAY86-6150), 50 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.
• BAY Factor VII (BAY86-6150)
BAY Factor VII (BAY86-6150), 90 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.
• Placebo
Placebo will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Poland,  South Africa,  United Kingdom, 

References & Publications (1)

Mahlangu JN, Coetzee MJ, Laffan M, Windyga J, Yee TT, Schroeder J, Haaning J, Siegel JE, Lemm G. Phase I, randomized, double-blind, placebo-controlled, single-dose escalation study of the recombinant factor VIIa variant BAY 86-6150 in hemophilia. J Thromb — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events as a measure of safety and tolerability		Up to Day 50	Yes
Secondary	Pharmacokinetic assessment, based on plasma concentration of BAY86-6150		9 time points from pre-dosing on Day 1 up to 48 hours post-dosing	No
Secondary	Pharmacodynamic assessment, based on plasma hemostasis marker level		9 time points from pre-dosing on Day 1 up to 48 hours post-dosing	No
Secondary	Immunogenicity assessment, based on anti-BAY86-6150 binding antibody levels		3 time points from pre-dosing on Day 1 up to Day 50	Yes

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