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

  • STATUS
    Recruiting
  • End date
    Mar 20, 2022
  • participants needed
    60
  • sponsor
    Catalyst Biosciences
Updated on 20 June 2021

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).

Details
Condition Hemophilia A With Inhibitor, Hemophilia B With Inhibitor
Treatment MarzAA
Clinical Study IdentifierNCT04489537
SponsorCatalyst Biosciences
Last Modified on20 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of congenital hemophilia A or B with inhibitors
Male or Female, age 12 or older
History of frequent bleeding episodes
Affirmation of informed consent with signature confirmation and assent for children between ages 12 to 17 before any study related activities

Exclusion Criteria

Previous participation in a clinical trial evaluating a modified rFVIIa agent
Received an investigational drug within 30 days or 5 half-lives or absence of clinical effect
Known hypersensitivity to trial or related product
Known positive antibody to FVII or FVIIa detected by central lab at screening
Have a coagulation disorder other than hemophilia A or B
Be immunosuppressed
Significant contraindication to participate
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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