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Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Hemophilia A or B

NCT04489537 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-12-17

No results posted yet for this study

Summary

The purpose of the trial is to evaluate the safety and efficacy of MarzAA for on-demand treatment and control of bleeding episodes in hemophilia A or B patients with inhibitors compared with their standard of care (SOC).

Conditions

  • Hemophilia A With Inhibitor
  • Hemophilia B With Inhibitor

Interventions

BIOLOGICAL

MarzAA

A cross over design to assess the efficacy of a dosing regimen of 60 µg/kg of MarzAA compared with standard of care for the treatment of bleeding episodes.

Sponsors & Collaborators

  • Catalyst Biosciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-04
Primary Completion
2021-11-15
Completion
2021-12-01
FDA Drug
Yes

Countries

  • United States
  • Armenia
  • Georgia
  • Hungary
  • India
  • Italy
  • Malaysia
  • Mexico
  • Poland
  • Russia
  • South Africa
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

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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 NCT04489537 on ClinicalTrials.gov