Back to resultsStudy to Test the Safety of an Investigational Drug Given Repeatedly to Adult Men With Severe Hemophilia
Primary Purpose
Hemophilia
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BAY1093884
Sponsored by
About this trial
This is an interventional other trial for Hemophilia focused on measuring Coagulation Factor VIII (FVIII), Coagulation Factor IX (FIX), Anti-tissue factor pathway inhibitor (aTFPI), Human monoclonal immunoglobulin G2 antibody
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hemophilia
Arm Description
Dose escalation starting with 200 mg of BAY1093884
Outcomes
Primary Outcome Measures
Frequency of drug-related adverse events
Frequency of drug-related serious adverse events
Frequency of adverse events of special interest
Adverse events of special interest comprise thromboembolic and thrombotic microangiopathy events, and hypersensitivity reactions.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03996486
Brief Title
Study to Test the Safety of an Investigational Drug Given Repeatedly to Adult Men With Severe Hemophilia
Official Title
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
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Company decision
Study Start Date
October 28, 2019 (Anticipated)
Primary Completion Date
May 29, 2020 (Anticipated)
Study Completion Date
July 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the safety of a test drug to treat hemophilia in adult men.
Detailed Description
The primary objective is to assess the safety of multiple doses of BAY1093884.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia
Keywords
Coagulation Factor VIII (FVIII), Coagulation Factor IX (FIX), Anti-tissue factor pathway inhibitor (aTFPI), Human monoclonal immunoglobulin G2 antibody
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hemophilia
Arm Type
Experimental
Arm Description
Dose escalation starting with 200 mg of BAY1093884
Intervention Type
Drug
Intervention Name(s)
BAY1093884
Other Intervention Name(s)
Human monoclonal immunoglobulin G2 antibody blocking the endogenous tissue factor pathway inhibitor (TFPI)
Intervention Description
Drug administered via subcutaneous injections once weekly for 6 weeks (= 6 doses)
Primary Outcome Measure Information:
Title
Frequency of drug-related adverse events
Time Frame
Up to 3 months
Title
Frequency of drug-related serious adverse events
Time Frame
Up to 3 months
Title
Frequency of adverse events of special interest
Description
Adverse events of special interest comprise thromboembolic and thrombotic microangiopathy events, and hypersensitivity reactions.
Time Frame
Up to 3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Learn more about this trial
Study to Test the Safety of an Investigational Drug Given Repeatedly to Adult Men With Severe Hemophilia
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