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出境医 / 临床实验 / Study to Test the Safety of an Investigational Drug Given Repeatedly to Adult Men With Severe Hemophilia

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

Study Description
Brief Summary:
The purpose of this study is to investigate the safety of a test drug to treat hemophilia in adult men.

Condition or disease Intervention/treatment Phase
Hemophilia Drug: BAY1093884 Phase 1

Detailed Description:
The primary objective is to assess the safety of multiple doses of BAY1093884.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Estimated Study Start Date : October 28, 2019
Estimated Primary Completion Date : May 29, 2020
Estimated Study Completion Date : July 31, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Hemophilia
Dose escalation starting with 200 mg of BAY1093884
 Drug: BAY1093884
Drug administered via subcutaneous injections once weekly for 6 weeks (= 6 doses)
Other Name: Human monoclonal immunoglobulin G2 antibody blocking the endogenous tissue factor pathway inhibitor (TFPI)
Outcome Measures
Primary Outcome Measures :
  1. Frequency of drug-related adverse events [ Time Frame: Up to 3 months ]
  2. Frequency of drug-related serious adverse events [ Time Frame: Up to 3 months ]
  3. 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE June 21, 2019
First Posted Date  ICMJE June 24, 2019
Last Update Posted Date October 22, 2019
Estimated Study Start Date  ICMJE October 28, 2019
Estimated Primary Completion Date May 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Test the Safety of an Investigational Drug Given Repeatedly to Adult Men With Severe Hemophilia
Official Title  ICMJE A Multicenter, Non-randomized, Open-label, Multiple Dose Escalation Study to Evaluate the Safety and Tolerability of Subcutaneous BAY1093884 in Males With Severe Hemophilia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Hemophilia
Intervention  ICMJE Drug: BAY1093884
Drug administered via subcutaneous injections once weekly for 6 weeks (= 6 doses)
Other Name: Human monoclonal immunoglobulin G2 antibody blocking the endogenous tissue factor pathway inhibitor (TFPI)
Study Arms  ICMJE Experimental: Hemophilia
Dose escalation starting with 200 mg of BAY1093884
Intervention: Drug: BAY1093884
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 21, 2019) 		0
Original Estimated Enrollment  ICMJE
 (submitted: June 21, 2019) 		30
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date May 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Ukraine,   United States
 
Administrative Information
NCT Number  ICMJE NCT03996486
Other Study ID Numbers  ICMJE 20414
2018-004566-34 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
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.
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bayer
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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