Study to Test the Safety of an Investigational Drug Given Repeatedly to Adult Men With Severe Hemophilia

Overview

The purpose of this study is to investigate the safety of a test drug to treat hemophilia in adult men.

Full Title of Study: “A Multicenter, Non-randomized, Open-label, Multiple Dose Escalation Study to Evaluate the Safety and Tolerability of Subcutaneous BAY1093884 in Males With Severe Hemophilia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 29, 2020

Detailed Description

The primary objective is to assess the safety of multiple doses of BAY1093884.

Interventions

  • Drug: BAY1093884
    • Drug administered via subcutaneous injections once weekly for 6 weeks (= 6 doses)

Arms, Groups and Cohorts

  • Experimental: Hemophilia
    • Dose escalation starting with 200 mg of BAY1093884

Clinical Trial Outcome Measures

Primary Measures

  • Frequency of drug-related adverse events
    • Time Frame: Up to 3 months
  • Frequency of drug-related serious adverse events
    • Time Frame: Up to 3 months
  • Frequency of adverse events of special interest
    • Time Frame: Up to 3 months
    • Adverse events of special interest comprise thromboembolic and thrombotic microangiopathy events, and hypersensitivity reactions.

Participating in This Clinical Trial

Inclusion Criteria

  • Participants with hemophilia A and FVIII activity <1% or hemophilia B with FIX activity <2% – Participants must be currently without inhibitors or with low titer inhibitors (inhibitor titer < 5 Bethesda units) who are receiving current on demand treatment with any FVIII or FIX (recombinant or plasma-derived; modified or unmodified) Exclusion Criteria:
  • History or at risk of developing diseases related to venous thromboembolic events (e.g., pulmonary embolism, deep vein thrombosis or thrombophlebitis) – History of any other clinically relevant coagulation disorder (particularly disseminated intravascular coagulopathy or combined FVIII/Factor V deficiency) or platelet disorder – History or at risk of developing cardiac, coronary and/or arterial peripheral atherosclerotic disease and/or arterial thromboembolic events, particularly myocardial infarction, cerebrovascular accident, stroke, transient ischemic attack, congestive heart failure, angina pectoris, treatment for angina pectoris or uncontrolled hypertension – History or at risk for thrombotic microangiopathy
  • Gender Eligibility: Male

    Minimum Age: 18 Years

    Maximum Age: 65 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Bayer
    • Provider of Information About this Clinical Study
      • Sponsor

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