Multiple escalating dose study of BAY 1093884 in adults with hemophilia A or B with or without inhibitors

Multiple escalating dose study of BAY 1093884 in adults with hemophilia A or B with or without inhibitors - n.a.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003324-67-GB

Enrollment

Registered

2018-03-20

Start date

2018-06-22

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A or B MedDRA version: 20.0 Level: LLT Classification code 10053751 Term: Hemophilia A with anti factor VIII System Organ Class: 100000004850 MedDRA version: 20.0 Level: LLT Classification code 10053753 Term: Hemophilia A without inhibitors System Organ Class: 100000004850 MedDRA version: 20.0

Interventions

Product Name: anti-TFPI (Tissue Factor Pathway Inhibitor) antibody Product Code: BAY1093884 Pharmaceutical Form: Solution for injection INN or Proposed

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Male severe hemophilic patients with undetectable FVIII activity =65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: 1. History of any other coagulation disorder (particularly disseminated intravascular coagulopathy or combined FVIII/FV deficiency) or platelet disorder. 2. History of diseases related to venous thromboembolic events (e.g., pulmonary embolism, deep vein thrombosis, thrombophlebitis) or thrombotic microangiopathy. 3. Risk factors for venous or arterial diseases (e.g., uncontrolled hypertension, uncontrolled diabetes). 4. History of cardiac, coronary and/or arterial peripheral atherosclerotic disease, particularly myocardial infarction, cerebrovascular accident, stroke, transient ischemic attack, congestive heart failure, angina pectoris or treatment for angina pectoris. 5. Platelet count 3 x the upper limit of the normal range and/or total bilirubin >2.0 x the upper limit of the normal range). 11. Subjects with serum creatinine >2.0 x the upper limit of the normal range. 12. Treatment with an investigational drug within 3 months prior to enrolment. 13. Subjects not willing to stop prophylaxis or ITI.

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): There is no secondary endpoint;Timepoint(s) of evaluation of this end point: n/a	—

Primary

Measure	Time frame
Main Objective: To assess the safety and tolerability of multiple subcutaneous doses of BAY 1093884 in subjects with hemophilia A or B with or without inhibitors. ; Secondary Objective: There are no secondary objectives in the trial. ; Primary end point(s): The primary endpoint is safety as defined by the frequency of drug-related AEs, SAEs, AESIs and clinically relevant abnormal laboratory values. Another safety endpoint will be the frequency of binding and neutralizing antibodies against BAY 1093884. ;Timepoint(s) of evaluation of this end point: Throughout the conduct of the study.	—

Measure

Time frame

Main Objective: To assess the safety and tolerability of multiple subcutaneous doses of BAY 1093884 in subjects with hemophilia A or B with or without inhibitors. ; Secondary Objective: There are no secondary objectives in the trial. ; Primary end point(s): The primary endpoint is safety as defined by the frequency of drug-related AEs, SAEs, AESIs and clinically relevant abnormal laboratory values. Another safety endpoint will be the frequency of binding and neutralizing antibodies against BAY 1093884. ;Timepoint(s) of evaluation of this end point: Throughout the conduct of the study.

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Countries

Australia, Austria, Bulgaria, France, Hungary, Italy, Japan, Korea, Republic of, New Zealand, Taiwan, United Kingdom

Contacts

Public ContactBayer Clinical Trials Contact

Bayer AG

clinical-trials-contact@bayer.com+4930300139003

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026