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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Laboratoire français de Fractionnement et de Biotechnologies
Study ID
NCT05904210
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • SEVENFACT® — DRUG
    Coagulation Factor VIIa (Recombinant)

Study Details

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®.

Key Dates

First listed
Jun 15, 2023
Start date
Nov 7, 2023
Status verified
Jun 2024
Primary completion
May 9, 2024
Completion
May 9, 2024

Study Design

Enrollment
17 participants (actual)

Arms

  • Arm: Patients treated by SEVENFACT®
    Patients that initiated treatment with SEVENFACT® in real-world clinical care in the USA will be eligible. Data from eligible patients' medical charts, bleeding diaries, and medication logs will be extracted from the time of initiation of SEVENFACT® treatment and for each bleeding episode and surgery or invasive procedure requiring treatment with SEVENFACT® or for prophylaxis, up until the data collection at the investigational site.

Primary Outcome Measure

SEVENFACT® effectiveness [ Time Frame: For all events which took place from Jan 1st, 2021 up to site opening in 2023 ]

Locations (8)

FacilityCityStateZIPSite coordinators
Luskin Orthopaedic Institute for ChildrenLos AngelesCalifornia90007-
Valley Children's HospitalMaderaCalifornia93636-
Children's healthcare of AtlantaAtlantaGeorgia30322-
Mayo ClinicRochesterMinnesota55905-
SUNY Upstate Medical University, Pediatric Hematology/OncologySyracuseNew York13210-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
The Gulf States Hemophilia & Thrombophilia CenterHoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
Luskin Orthopaedic Institute for Children· Los Angeles, CAValley Children's Hospital· Madera, CAChildren's healthcare of Atlanta· Atlanta, GAMayo Clinic· Rochester, MNSUNY Upstate Medical University, Pediatric Hematology/Oncology· Syracuse, NYUniversity Hospitals Cleveland Medical Center· Cleveland, OH

Related Studies