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

Retrospective Experience Assessing the Real-World Utilization and Effectiveness of SEVENFACT® [Coagulation Factor VIIa (Recombinant) - Jncw] in the USA

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05904210

Enrollment

Registered

2023-06-15

Start date

2023-11-07

Completion date

2024-05-09

Last updated

2024-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia

Keywords

inhibitors, eptacog beta, recombinant factor 7, real-world evidence

Brief 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®.

Detailed 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.

Interventions

DRUGSEVENFACT®

Coagulation Factor VIIa (Recombinant)

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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, and documented written informed consent/assent.

Exclusion criteria

Not applicable

Design outcomes

Primary

Measure	Time frame	Description
SEVENFACT® effectiveness	For all events which took place from Jan 1st, 2021 up to site opening in 2023	SEVENFACT® effectiveness will be evaluated based on the retrospective rating by the investigator using the Clinical Global Impression Efficacy Index (CGI-E) for each 'event' (bleeding episode, surgery or invasive procedure, or prophylaxis). Specifically, the proportion of patients receiving efficient treatment based on CGI-E will be estimated.

Secondary

Measure	Time frame	Description
Patient profile analysis	For all events which took place from Jan 1st, 2021 up to site opening in 2023	The patient profile of patients treated with SEVENFACT® will be evaluated based on the patient's socio-demography, medical history, potential comorbidities, physical examination, current medications, and bleeding disorder history

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026