Trial record 3 of 6 for: "Hemophilia" | "HIV Protease Inhibitors"
Study to Test the Safety of an Investigational Drug Given Repeatedly to Adult Men With Severe Hemophilia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03996486|
Recruitment Status : Withdrawn (Company decision)
First Posted : June 24, 2019
Last Update Posted : October 22, 2019
Information provided by (Responsible Party):
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|
The primary objective is to assess the safety of multiple doses of BAY1093884.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|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|
Dose escalation starting with 200 mg of 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)
Primary Outcome Measures :
- 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.
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