Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hemophilia | Drug: BAY1093884 | Phase 1 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: Hemophilia
Dose escalation starting with 200 mg of BAY1093884
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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)
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
No Contacts or Locations Provided
Tracking Information | |||||
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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 |
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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 |
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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)
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Study Arms ICMJE | Experimental: Hemophilia
Dose escalation starting with 200 mg of BAY1093884
Intervention: Drug: BAY1093884
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Withdrawn | ||||
Actual Enrollment ICMJE |
0 | ||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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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 |