stop_circleTerminated/Withdrawn

Hemophilia

Bayer Identifier:
20414
ClinicalTrials.gov Identifier:
NCT03996486
EudraCT Number:
2018-004566-34
EU CT Number:
Not Available
Study to test the safety of an investigational drug given repeatedly to adult men with severe hemophilia

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

18 - 65 Years
  • - 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)

  • - 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

Trial summary

Enrollment Goal
0
Trial Dates
October 2019 - July 2020
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY1093884
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
University of Colorado HospitalAurora, 80045, United States
Withdrawn
Institute of Blood Pathology and Transfusion medicineLviv, 79044, Ukraine
Withdrawn
City Clinical Hospital #9Kiev, Ukraine
Withdrawn
Rush University Medical CenterChicago, 60612, United States
Withdrawn
University of Minnesota Medical CenterMinneapolis, 55455, United States
Withdrawn
Rutgers Robert Wood Johnson Medical SchoolNew Brunswick, 08901, United States

Primary Outcome

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

Trial design

A multicenter, non-randomized, open-label, multiple dose escalation study to evaluate the safety and tolerability of subcutaneous BAY1093884 in males with severe hemophilia
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
Sequential Assignment
Trial Arms
1