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

Hemophilia Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03996486
• Other study ID #: 20414
• Secondary ID: 2018-004566-34
• Status: Withdrawn
• Phase: Phase 1
• Start date: October 28, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: October 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the safety of a test drug to treat hemophilia in adult men.

Description:

The primary objective is to assess the safety of multiple doses of BAY1093884.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 31, 2020
• Est. primary completion date: May 29, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemophilia
• Hemophilia A

Intervention

Drug:
• BAY1093884
Drug administered via subcutaneous injections once weekly for 6 weeks (= 6 doses)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Outcome

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