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Completed

NCT Number: NCT03197688

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

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.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

CardioPulmonary Research Center, Guaynabo, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Notapplicable

Other

Not applicable as non-interventional study

Primary outcomes

  1. Estimation of incidence rates of adverse events

    Time frame: 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 outcomes

  1. Description of demographic characteristics of patients

    Time frame: 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

  2. Description of clinical characteristics of patients

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study title

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

Acronym: OrPHeUS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 23, 2017
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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