Study Stopped
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Study to Test the Safety of an Investigational Drug Given Repeatedly to Adult Men With Severe Hemophilia
A Multicenter, Non-randomized, Open-label, Multiple Dose Escalation Study to Evaluate the Safety and Tolerability of Subcutaneous BAY1093884 in Males With Severe Hemophilia
2 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
The purpose of this study is to investigate the safety of a test drug to treat hemophilia in adult men.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2019
CompletedFirst Posted
Study publicly available on registry
June 24, 2019
CompletedStudy Start
First participant enrolled
October 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2020
CompletedOctober 22, 2019
October 1, 2019
7 months
June 21, 2019
October 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Frequency of drug-related adverse events
Up to 3 months
Frequency of drug-related serious adverse events
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.
Up to 3 months
Study Arms (1)
Hemophilia
EXPERIMENTALDose escalation starting with 200 mg of BAY1093884
Interventions
Drug administered via subcutaneous injections once weekly for 6 weeks (= 6 doses)
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2019
First Posted
June 24, 2019
Study Start
October 28, 2019
Primary Completion
May 29, 2020
Study Completion
July 31, 2020
Last Updated
October 22, 2019
Record last verified: 2019-10