Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Inherited Bleeding Disorders

  • STATUS
    Recruiting
  • End date
    Mar 28, 2022
  • participants needed
    24
  • sponsor
    Catalyst Biosciences
Updated on 28 June 2021

Summary

The purpose of the trial is to evaluate the PK, bioavailability, PD, efficacy and safety of MarzAA for on demand treatment and control of bleeding episodes in adult subjects with inherited bleeding disorders.

Details
Condition Thrombasthenia, Thrombocytopathy, Factor VII Deficiency, Platelet Deficiencies, Hemophilia A With Inhibitor, Platelet Disorders, glanzmann's thrombasthenia, thromboasthenia
Treatment Coagulation Factor VIIa variant
Clinical Study IdentifierNCT04548791
SponsorCatalyst Biosciences
Last Modified on28 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of cohort: FVII deficiency, Glanzmann Thrombasthenia, or hemophilia A 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
Agreement to use highly effective birth control throughout the study if the subject has childbearing potential

Exclusion Criteria

Genotype of FVIID subjects with identified mutations by central lab at screening
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, whichever is longer
Known hypersensitivity to trial or related product
Known positive antibody to FVII or FVIIa detected by central lab at screening
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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