Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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Recruitment Status : Withdrawn (Company decision)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
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03996486     History of Changes
Other Study ID Numbers: 20414
2018-004566-34 ( EudraCT Number )
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Coagulation Factor VIII (FVIII)
Coagulation Factor IX (FIX)
Anti-tissue factor pathway inhibitor (aTFPI)
Human monoclonal immunoglobulin G2 antibody
Additional relevant MeSH terms:
Layout table for MeSH terms
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Lipoprotein-associated coagulation inhibitor
Thromboplastin
Antibodies
Immunoglobulins
Immunoglobulin G
Myeloma Proteins
Paraproteins
 Immunologic Factors
Physiological Effects of Drugs
Hemostatics
Coagulants
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Factor Xa Inhibitors
Antithrombins