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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-07

Study Completion Date

2024-05-09

Brief Summary

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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®.

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Detailed Description

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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.

Conditions

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Hemophilia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

SEVENFACT®

Intervention Type DRUG

Coagulation Factor VIIa (Recombinant)

Interventions

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SEVENFACT®

Coagulation Factor VIIa (Recombinant)

Intervention Type DRUG

Eligibility Criteria

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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.