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

March 28, 2025 updated by: Actelion

Multicenter, 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Guaynabo, Puerto Rico, 00968
        • CardioPulmonary Research Center
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Pulmonary Associates
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic - Arizona
      • Phoenix, Arizona, United States, 85032
        • Cardiovascular Consultants
    • California
      • La Jolla, California, United States, 93093
        • University of California San Diego
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Los Angeles, California, United States, 90095-1690
        • David Geffen School of Medicine at University of California Los Angeles
      • San Francisco, California, United States, 94143
        • UCSF School of Medicine
      • San Juan Capistrano, California, United States, 92675
        • Paloma Medical Group
      • Santa Barbara, California, United States, 93105
        • Santa Barbara Cottage Hospital
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University
    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital
    • Florida
      • Brandon, Florida, United States, 33511
        • Bay Area Cardiology Associates
      • Celebration, Florida, United States, 34747
        • Florida Lung, Asthma and Sleep Specialists
      • Fort Lauderdale, Florida, United States, 33316
        • Frank Hull, MD, PA
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Hudson, Florida, United States, 34667
        • West Pasco Pulmonary Associates
      • Jacksonville, Florida, United States, 32209
        • Saint Vincent's Medical Center
      • Leesburg, Florida, United States, 34748
        • Medical Research of Central Florida
      • Melbourne, Florida, United States, 32901
        • Independent Lung Associates
      • Miami, Florida, United States, 33136
        • University of Miami
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Comprehensive Cancer Center
      • Orlando, Florida, United States, 32803
        • Central Florida Pulmonary Group, P.A. - Downtown Orlando Office
      • Saint Petersburg, Florida, United States, 33704
        • Coastal Pulmonary and Critical Care
      • Sebring, Florida, United States, 33870
        • Bassetti Medical Research Inc
      • South Miami, Florida, United States, 33143
        • Cardiovascular Medicine Associates
      • Tampa, Florida, United States, 33606
        • University of South Florida
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida Hospital
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic
    • Georgia
      • Austell, Georgia, United States, 30106
        • Piedmont Healthcare
      • Columbus, Georgia, United States, 31904
        • Southeastern Cardiology Associates
      • Marietta, Georgia, United States, 30060
        • Wellstar Marietta Pulmonary Medicine
    • Idaho
      • Shelley, Idaho, United States, 83274
        • Bingham Memorial Hospital
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Indiana
      • Carmel, Indiana, United States, 46032
        • IU Health Physicians Pulmonary & Critical Care
      • Fort Wayne, Indiana, United States, 46804
        • Lutheran Hospital
      • Greenwood, Indiana, United States, 46143
        • Indiana Internal Medicine Consultants
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Medical Group, Inc.
    • Iowa
      • Clive, Iowa, United States, 50325
        • CIC Associates
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • The University of Kansas Physicians
    • Kentucky
      • Erlanger, Kentucky, United States, 41018
        • St. Elizabeth Healthcare Clinical Research Institute
      • Louisville, Kentucky, United States, 40202
        • Kentuckiana Pulmonary Associates
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center
      • New Orleans, Louisiana, United States, 70112
        • LSU Health Sciences Center
      • Shreveport, Louisiana, United States, 71105
        • Pulmonary & Critical Care Specialists
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02118
        • Boston University Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Medical Center
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Lansing, Michigan, United States, 48912
        • Sparrow Clinical Research Institute
      • Troy, Michigan, United States, 48085
        • Beaumont Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407-3799
        • Minneapolis Heart Institute
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Mercy Hospital Saint Louis
      • Saint Louis, Missouri, United States, 63104
        • Saint Louis University
      • Saint Louis, Missouri, United States, 63136
        • Pulmonary Consultants Inc-St. Louis
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Nebraska Pulmonary Specialties, LLC
      • Omaha, Nebraska, United States, 68198-5990
        • University of Nebraska Medical Center
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Barnabas Health Ambulatory Care Center
      • Union, New Jersey, United States, 07083
        • Pulmonary and Critical Care Associates
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-0001
        • University of New Mexico
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center - Bronx
      • Fayetteville, New York, United States, 13066
        • Pulmonary Health Physicians
      • Hauppauge, New York, United States, 11788
        • Stony Brook University Hospital
      • Middletown, New York, United States, 10941
        • Temple University Hospital
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital, Clinical Trials Center
      • New York, New York, United States, 10029
        • Mount Sinai
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Hospitals
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • University of Cincinnati
      • Columbus, Ohio, United States, 43210
        • Ohio State University, Wexner Medical Center
      • Columbus, Ohio, United States, 43213
        • Mount Carmel Medical Group
      • Dayton, Ohio, United States, 45459
        • Midwest Pulmonary & Sleep Research
      • Middleburg Heights, Ohio, United States, 44130
        • Southwest General Health Center
      • Toledo, Ohio, United States, 43614
        • The University of Toledo Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Heart Hospital
    • Oregon
      • Portland, Oregon, United States, 97210
        • Legacy Research Institute
      • Portland, Oregon, United States, 97225
        • The Oregon Clinic
      • Portland, Oregon, United States, 97201-3098
        • Oregon Health & Science University
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18907
        • Doylestown Health Cardiology, a division of Doylestown Health Physicians
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Medical Center
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health Medical Center
      • Rock Hill, South Carolina, United States, 29732
        • Carolina Cardiology Associates
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Sioux Falls Cardiovascular PC
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Memorial Research Center
      • Memphis, Tennessee, United States, 38157
        • Mid-South Pulmonary Specialists
    • Texas
      • Dallas, Texas, United States, 75390-8550
        • University of Texas Southwestern Medical Center at Dallas
      • Denison, Texas, United States, 75020
        • Premier Pulmonary CC and Sleep Medicine, PA
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Houston
      • Plano, Texas, United States, 75093
        • Baylor Regional Medical Center at Plano
      • Temple, Texas, United States, 76508-0001
        • Scott and White Memorial Hospital
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington
      • Spokane, Washington, United States, 99204-4800
        • Spokane Respiratory Consultants
      • Tacoma, Washington, United States, 98405
        • Cardiac Study Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Health Care - Saint Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who initiated Opsumit for the first time between 19 October 2013 and 31 December 2016 (inclusive) are eligible for OrPHeUS (i.e., eligibility period).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Notapplicable
Not applicable as non-interventional study
Other: Notapplicable
Not applicable as non-interventional study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018
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
Observation period from 19 Oct 2013 to 31 March 2017, Data collection from 1 Apr 2017 to 30 Jun 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Actelion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 6, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 6, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AC-055-510

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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