NCT03481946 is a Phase 1 clinical trial of BAY1093884 in Hemophilia A; Hemophilia B, sponsored by Bayer.

Who is sponsoring NCT03481946?

NCT03481946 is sponsored by Bayer.

What drugs are being tested in NCT03481946?

Interventions in NCT03481946: BAY1093884, BAY1093884.

What condition does NCT03481946 study?

NCT03481946 studies Hemophilia A; Hemophilia B.

Is NCT03481946 still recruiting?

NCT03481946 is currently completed. Last updated 16 September 2020.

Last reviewed 2020-09-16 · How we verify

NCT03481946

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Assess Pharmacokinetics and Pharmacodynamics Following Administration of BAY1093884 in Patients With Severe Hemophilia

Completed Phase 1 Last updated 16 September 2020

What this trial tests

Phase 1 trial testing BAY1093884 in Hemophilia A; Hemophilia B in 6 participants. Completed in 20 February 2019.

Timeline

10 May 2018

Primary endpoint
17 October 2018

20 February 2019

Quick facts

Lead sponsor	Bayer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	6
Start date	10 May 2018
Primary completion	17 October 2018
Estimated completion	20 February 2019
Sites	1 location across Israel

Drugs / interventions tested

BAY1093884 — full drug profile →
BAY1093884 — full drug profile →

Conditions studied

Hemophilia A; Hemophilia B — all drugs for Hemophilia A; Hemophilia B →

Sponsor

Bayer — full company profile →

Who can join

Adults 18 to 65, male only, with Hemophilia A; Hemophilia B. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective of this study is to assess the pharmacokinetics in patients with severe hemophilia. The secondary objective is to assess the pharmacodynamics of BAY1093884 based on tissue factor pathway inhibitor activity

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Inhibitors in haemophilia A and B: Management of bleeds, inhibitor eradication and strategies for difficult-to-treat patients.
Ljung R, Auerswald G, Benson G, Dolan G, et al · · 2019 · cited 82× · PMID 30411401 · DOI 10.1111/ejh.13193
A Molecular Revolution in the Treatment of Hemophilia.
Butterfield JSS, Hege KM, Herzog RW, Kaczmarek R. · · 2020 · cited 76× · PMID 31843450 · DOI 10.1016/j.ymthe.2019.11.006
Progress in the Development of Anti-tissue Factor Pathway Inhibitors for Haemophilia Management.
Mahlangu JN. · · 2021 · cited 18× · PMID 34026796 · DOI 10.3389/fmed.2021.670526

Verify or expand the search:

Other trials of BAY1093884

Trials testing the same drug.

NCT03996486 — Study to Test the Safety of an Investigational Drug Given Repeatedly to Adult Men With Severe Hemophilia · Phase 1 · withdrawn
NCT02571569 — A Single Escalating Dose and Multiple Dose Study of BAY 1093884 in Subjects With Severe Hemophilia Types A or B, With or · Phase 1 · completed

Other Bayer trials

Trials by the same sponsor.

NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03481946 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 16 September 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03481946.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing