Brief Title
Study of FVIIa Variant BAY86-6150 (B0189) in Subjects With Moderate or Severe Hemophilia Types A or B With or Without Inhibitors
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
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Number of participants with adverse events as a measure of safety and tolerability
Secondary Outcome
Pharmacokinetic assessment, based on plasma concentration of BAY86-6150
Condition
Hemophilia A
Intervention
BAY Factor VII (BAY86-6150)
Study Arms / Comparison Groups
BAY Factor VII (6.5 µg/kg) / Placebo
Description: n = 4, randomized 3:1; 6.5 µg/kg BAY 86-6150 (B0189):Placebo
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
16
Start Date
January 2009
Completion Date
December 2009
Primary Completion Date
December 2009
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
Gender
Male
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Bayer Study Director, ,
Location Countries
Poland
Location Countries
Poland
Administrative Informations
NCT ID
NCT01921855
Organization ID
13787
Secondary IDs
2008-000117-29
Responsible Party
Sponsor
Study Sponsor
Bayer
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
August 2014