Retrospective Experience Assessing the Real-World Utilization and Effectiveness of SEVENFACT®

Last updated: June 24, 2024
Sponsor: Laboratoire français de Fractionnement et de Biotechnologies
Overall Status: Completed

Phase

N/A

Condition

Hemophilia

Treatment

SEVENFACT®

Clinical Study ID

NCT05904210
F7TG2204
  • All Genders

Study Summary

Retrospective Experience Assessing the Real-World Utilization and Effectiveness of SEVENFACT® [coagulation factor VIIa (recombinant)-jncw] in the USA.

The current study will provide a unique opportunity to describe the profile of the early patients selected for treatment with SEVENFACT® and to assess the real-world utilization (effectiveness, safety, tolerability, and modalities of treatment) of SEVENFACT®.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient received SEVENFACT® before study initiation.

  2. If collection of a written informed consent is required for an investigational site (see Section 5.1 General Informed Consent), patient has read, understood, anddocumented written informed consent/assent.

Exclusion

Exclusion Criteria:

Not applicable

Study Design

Total Participants: 17
Treatment Group(s): 1
Primary Treatment: SEVENFACT®
Phase:
Study Start date:
November 07, 2023
Estimated Completion Date:
May 09, 2024

Study Description

Parameters collected will include patient socio-demographics, medical history / comorbidities, bleeding disorder history, physical examination, vital signs, prior and concomitant bleeding disorder treatments, bleeding episode / surgery or invasive procedure / prophylaxis details, information on SEVENFACTâ treatment modalities, retrospective investigator rating of SEVENFACTâ effectiveness using the Clinical Global Impression Efficacy Index (CGI-E) and time for bleed control, Adverse Drug Experiences (ADEs) temporally associated with SEVENFACTâ administration, special situations that occurred during SEVENFACTâ administration, whether or not associated with ADE, laboratory testing for activation of the coagulation system or thrombosis, physical examination, and vital signs.

Connect with a study center

  • Luskin Orthopaedic Institute for Children

    Los Angeles, California 90007
    United States

    Site Not Available

  • Valley Children's Hospital

    Madera, California 93636
    United States

    Site Not Available

  • Children's healthcare of Atlanta

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • SUNY Upstate Medical University, Pediatric Hematology/Oncology

    Syracuse, New York 13210
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • The Gulf States Hemophilia & Thrombophilia Center

    Houston, Texas 77030
    United States

    Site Not Available

  • MedStar Georgetown University Hospital

    Northwest, Washington 20007
    United States

    Site Not Available

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