A Single Escalating Dose and Multiple Dose Study of BAY 1093884 in Subjects With Severe Hemophilia Types A or B, With or Without Inhibitors

Brief Title

A Single Escalating Dose and Multiple Dose Study of BAY 1093884 in Subjects With Severe Hemophilia Types A or B, With or Without Inhibitors

Official Title

A Phase 1, First in Man, Multicenter, Open Label, Single Escalating Dose Study of BAY1093884 in Subjects With Severe Hemophilia Types A or B, With or Without Inhibitors

Brief Summary

      Investigate the safety, tolerability and pharmacokinetics of BAY1093884 after Intravenous
      (IV) and subcutaneous (SC) administration of increasing single doses and SC administration of
      multiple doses.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Number of participants (single dose cohors) with adverse events as measure of safety and tolerability

Secondary Outcome

 Tissue factor pathway inhibitor (TFPI) activity

Condition

Hemophilia A

Intervention

BAY1093884

Study Arms / Comparison Groups

 Without inhibitors

Description:  Dose escalation steps for participants without inhibitors - intravenous infusion and subcutaneous injection

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

October 28, 2015

Completion Date

October 11, 2018

Primary Completion Date

July 9, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Males with severe congenital Hemophilia A or B defined as <1% FVIII or Factor IX (FIX)
             concentration by measurement at the time of screening or from reliable prior
             documentation

          -  For subjects in Cohorts I-IV, I-SC1 and I-SC2; If history of inhibitors is evident,
             inhibitor titer of ≥5 Bethesda Units (BU) at screening or prior to screening at any
             time from medical records.

          -  Age: 18 to 65 years of age at screening

          -  Body mass index (BMI): 18 to 29.9 kg/m²

        Exclusion Criteria:

          -  Subjects with known bleeding disorders (such as von Willebrand factor [vWF]
             deficiency, FXI deficiency, platelet disorders, or known acquired or inherited
             thrombophilia etc.) other than congenital Hemophilia A or B with or without inhibitors

          -  History of angina pectoris or treatment for angina pectoris

          -  History of coronary and/or peripheral atherosclerotic disease, congestive heart
             failure, disseminated intravascular coagulopathy, or stage 2 hypertension defined as
             systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥100 mmHg
             even if controlled

          -  History of thrombophlebitis, venous / arterial thromboembolic diseases (particularly
             deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction,
             cerebrovascular accident, ischemic heart disease, transient ischemic attack)

          -  Known or suspected hypersensitivity of the immune system, history of anaphylactic
             reaction, known (clinically relevant) allergies, non-allergic drug reactions, or
             multiple drug allergies

Gender

Male

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Bayer Study Director, ,

Location Countries

Bulgaria

Location Countries

Bulgaria

Administrative Informations

NCT ID

NCT02571569

Organization ID

Secondary IDs

2014-003283-20

Responsible Party

Sponsor

Study Sponsor

Bayer

Study Sponsor

Bayer Study Director, Study Director, Bayer

Verification Date

October 2018