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

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

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

Secondary IDs

2008-000117-29

Responsible Party

Sponsor

Study Sponsor

Bayer

Study Sponsor

Bayer Study Director, Study Director, Bayer

Verification Date

August 2014