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Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Inherited Bleeding Disorders | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

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

Phase 1/2 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Marzeptacog Alfa (Activated) in Treatment of Episodic Bleeding in Subjects With Inherited Bleeding Disorders

NCT04548791•Catalyst Biosciences

View on ClinicalTrials.gov

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (20)

UC Davis Medical Center

Sacramento, California, United States

University of California -San Francisco

San Francisco, California, United States

University of Colorado Hemophilia and Thrombosis Center

Aurora, Colorado, United States

Rush University

Chicago, Illinois, United States

Children's Hospital of Michigan

Detroit, Michigan, United States

Michigan State University Center for Bleeding Disorders & Clotting Disorders

East Lansing, Michigan, United States

East Carolina University

Greenville, North Carolina, United States

Mazumdar Shaw Medical Centre

Bengaluru, India

St. John's Medical College Hospital

Bengaluru, India

Amrita Institute of Medical Sciences and Research Centre

Kochi, India

Key Dates

Start Date

May 17, 2021

Primary Completion Date

November 15, 2021

Completion Date

December 3, 2021

Last Updated

December 21, 2021

Enrollment

ACTUAL participants

Conditions

Factor VII DeficiencyGlanzmann ThrombastheniaHemophilia A With Inhibitor

Interventions

Coagulation Factor VIIa variant

BIOLOGICAL

Eptacog Beta in Glanzmann's (HeT_LFB-Strength-Study_FID531)

NCT07136857

Glanzmann Thrombasthenia

View study

RECRUITINGNA

Videomicroscopy for the Prediction of Bleeding in Constitutional Haemorrhagic Diseases

NCT04119908

Von Willebrand DiseasesGlanzmann Thrombasthenia

View study

ACTIVE_NOT_RECRUITINGPHASE3

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 21, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Eptacog Beta in Glanzmann's (HeT_LFB-Strength-Study_FID531)

Videomicroscopy for the Prediction of Bleeding in Constitutional Haemorrhagic Diseases

Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B With Inhibitors

ATHN 7: Hemophilia Natural History Study

An Exploration of the Impact of Emicizumab on the Lives of People With Haemophilia and Inhibitors and Their Families

The Experiences of People Who Live With Glanzmanns Thrombasthenia.