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

A Multicenter, Non-randomized, Open-label, Multiple Dose Escalation Study to Evaluate the Safety and Tolerability of Subcutaneous BAY1093884 in Males With Severe Hemophilia

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03996486

Enrollment

Registered

2019-06-24

Start date

2019-10-28

Completion date

2020-07-31

Last updated

2019-10-22

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

Conditions

Hemophilia

Keywords

Coagulation Factor VIII (FVIII), Coagulation Factor IX (FIX), Anti-tissue factor pathway inhibitor (aTFPI), Human monoclonal immunoglobulin G2 antibody

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.

Interventions

DRUGBAY1093884

Drug administered via subcutaneous injections once weekly for 6 weeks (= 6 doses)

Study design

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Frequency of drug-related adverse events	Up to 3 months	—
Frequency of drug-related serious adverse events	Up to 3 months	—
Frequency of adverse events of special interest	Up to 3 months	Adverse events of special interest comprise thromboembolic and thrombotic microangiopathy events, and hypersensitivity reactions.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026