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Multiple Escalating Dose Study of BAY1093884 in Adults With Hemophilia A or B With or Without Inhibitors

NCT03597022 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-11-30

Study results available
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Summary

The purpose of this study was to assess the safety and tolerability of multiple doses of a human monoclonal antibody (BAY1093884) given under the skin in subjects with hemophilia A or B. This antibody was intended to protect from bleeds by inhibiting a substance (Tissue Factor Pathway Inhibitor, TFPI) that reduces the ability of the body to form blood clots.

Conditions

  • Hemophilia A and B

Interventions

DRUG

Befovacimab (BAY1093884)

Once weekly doses until premature termination of the study, subcutaneous injection

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-24
Primary Completion
2019-10-15
Completion
2019-10-15
FDA Drug
Yes

Countries

  • Australia
  • Austria
  • Bulgaria
  • France
  • Hungary
  • Italy
  • Japan
  • New Zealand
  • South Korea
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03597022 on ClinicalTrials.gov