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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Hammersmith Hospital London, United Kingdom, W12 0HS | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instytut Hematologii i Transfuzjologii Warszawa, Poland, 02-776 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Witwatersrand JOHANNESBURG, South Africa, 2193 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of the Free State Bloemfontein, South Africa, 9300 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
4
Primary Outcome
- Number of participants with adverse events as a measure of safety and tolerabilityTimeframe: Up to Day 50
Secondary Outcome
- Pharmacokinetic assessment, based on plasma concentration of BAY86-6150Timeframe: 9 time points from pre-dosing on Day 1 up to 48 hours post-dosing
- Pharmacodynamic assessment, based on plasma hemostasis marker levelTimeframe: 9 time points from pre-dosing on Day 1 up to 48 hours post-dosing
- Immunogenicity assessment, based on anti-BAY86-6150 binding antibody levelsTimeframe: 3 time points from pre-dosing on Day 1 up to Day 50
Additional Information
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