Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States

Completed

• Conditions: Pulmonary Arterial Hypertension

• Registration Number: NCT03197688
• Lead Sponsor: Actelion

Brief Summary

The Opsumit Users registry (OPUS; NCT02126943) was developed to characterize the safety profile of Opsumit and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting. It is expected that the recruitment target of the OPUS registry cannot be achieved within the planned time period (5000 Opsumit new users by October 2018). The OrPHeUS study is designed to supplement the OPUS registry with retrospectively identified first-time Opsumit users in order to achieve the desired sample size.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-12
• Study First Submitted QC: 2017-06-21
• Study First Posted: 2017-06-23
• Study Start: 2017-08-03
• Primary Completion: 2018-09-06
• Study Completion: 2018-09-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

• Patients who initiated Opsumit for the first time between 19 October 2013 and 31 December 2016 (inclusive)
• Patients whose medical charts are available for data collection

Exclusion Criteria

• Patient participation in the OPUS registry
• Patient participation in any clinical trial involving Opsumit treatment or macitentan investigational product

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimation of incidence rates of adverse events	Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018	Incidence rates of liver test abnormalities, Occurrence of Hepatic Adverse Events (HAEs), Occurrence of any other Adverse Event (AE), Occurrence and reason for discontinuation of Opsumit treatment, hospitalization and death

Secondary Outcome Measures

Name	Time	Method
Description of demographic characteristics of patients	Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018	To describe demographic characteristics of patients treated with Opsumit at beginning and during study time period
Description of clinical characteristics of patients	Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018	To describe clinical characteristics of patients treated with Opsumit at beginning and during study time period

Trial Locations

Locations (106)

Pulmonary Associates; 🇺🇸 Phoenix, Arizona, United States

Cardiovascular Consultants; 🇺🇸 Phoenix, Arizona, United States

Mayo Clinic - Arizona; 🇺🇸 Phoenix, Arizona, United States

University of California San Diego; 🇺🇸 La Jolla, California, United States

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

David Geffen School of Medicine at University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

UCSF School of Medicine; 🇺🇸 San Francisco, California, United States

Paloma Medical Group; 🇺🇸 San Juan Capistrano, California, United States

Santa Barbara Cottage Hospital; 🇺🇸 Santa Barbara, California, United States

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