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

Primary Purpose

Hemophilia A, Hemophilia B

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BAY Factor VII (BAY86-6150)
BAY Factor VII (BAY86-6150)
BAY Factor VII (BAY86-6150)
BAY Factor VII (BAY86-6150)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophilia A

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

BAY Factor VII (6.5 µg/kg) / Placebo

BAY Factor VII (20 µg/kg) / Placebo

BAY Factor VII (50 µg/kg) / Placebo

BAY Factor VII (90 µg/kg) / Placebo

Arm Description

n = 4, randomized 3:1; 6.5 µg/kg BAY 86-6150 (B0189):Placebo

n = 4, randomized 3:1; 20 µg/kg BAY 86-6150 (B0189):Placebo

n = 4, randomized 3:1; 50 µg/kg BAY 86-6150 (B0189):Placebo

n = 4, randomized 3:1; 90 µg/kg BAY 86-6150 (B0189):Placebo

Outcomes

Primary Outcome Measures

Number of participants with adverse events as a measure of safety and tolerability

Secondary Outcome Measures

Pharmacokinetic assessment, based on plasma concentration of BAY86-6150
Pharmacodynamic assessment, based on plasma hemostasis marker level
Immunogenicity assessment, based on anti-BAY86-6150 binding antibody levels

Full Information

First Posted
July 10, 2013
Last Updated
August 20, 2014
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT01921855
Brief Title
Study of FVIIa Variant BAY86-6150 (B0189) in Subjects With Moderate or Severe Hemophilia Types A or B With or Without Inhibitors
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia A, Hemophilia B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BAY Factor VII (6.5 µg/kg) / Placebo
Arm Type
Experimental
Arm Description
n = 4, randomized 3:1; 6.5 µg/kg BAY 86-6150 (B0189):Placebo
Arm Title
BAY Factor VII (20 µg/kg) / Placebo
Arm Type
Experimental
Arm Description
n = 4, randomized 3:1; 20 µg/kg BAY 86-6150 (B0189):Placebo
Arm Title
BAY Factor VII (50 µg/kg) / Placebo
Arm Type
Experimental
Arm Description
n = 4, randomized 3:1; 50 µg/kg BAY 86-6150 (B0189):Placebo
Arm Title
BAY Factor VII (90 µg/kg) / Placebo
Arm Type
Experimental
Arm Description
n = 4, randomized 3:1; 90 µg/kg BAY 86-6150 (B0189):Placebo
Intervention Type
Drug
Intervention Name(s)
BAY Factor VII (BAY86-6150)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
BAY Factor VII (BAY86-6150)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
BAY Factor VII (BAY86-6150)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
BAY Factor VII (BAY86-6150)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.
Primary Outcome Measure Information:
Title
Number of participants with adverse events as a measure of safety and tolerability
Time Frame
Up to Day 50
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Warszawa
ZIP/Postal Code
02-776
Country
Poland
City
Bloemfontein
State/Province
Freestate
ZIP/Postal Code
9300
Country
South Africa
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22353395
Citation
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 Haemost. 2012 May;10(5):773-80. doi: 10.1111/j.1538-7836.2012.04667.x.
Results Reference
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Study of FVIIa Variant BAY86-6150 (B0189) in Subjects With Moderate or Severe Hemophilia Types A or B With or Without Inhibitors

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