check_circleStudy 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
  • - 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
  • - 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
January 2009 - December 2009
Phase
Phase 1
Could I Receive a placebo
Yes
Products
BAY86-6150
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Hammersmith HospitalLondon, W12 0HS, United Kingdom
Completed
Instytut Hematologii i TransfuzjologiiWarszawa, 02-776, Poland
Completed
University of WitwatersrandJOHANNESBURG, 2193, South Africa
Completed
University of the Free StateBloemfontein, 9300, South Africa

Primary Outcome

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

Secondary Outcome

  • Pharmacokinetic assessment, based on plasma concentration of BAY86-6150
    date_rangeTime Frame:
    9 time points from pre-dosing on Day 1 up to 48 hours post-dosing
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    Safety Issue:
    No
  • Pharmacodynamic assessment, based on plasma hemostasis marker level
    date_rangeTime Frame:
    9 time points from pre-dosing on Day 1 up to 48 hours post-dosing
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    Safety Issue:
    No
  • Immunogenicity assessment, based on anti-BAY86-6150 binding antibody levels
    date_rangeTime Frame:
    3 time points from pre-dosing on Day 1 up to Day 50
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    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
4

Additional Information

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