Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States
OrPHeUS
Multicenter, Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States
1 other identifier
observational
2,200
2 countries
106
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2017
106 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2017
CompletedFirst Posted
Study publicly available on registry
June 23, 2017
CompletedStudy Start
First participant enrolled
August 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2018
CompletedMarch 30, 2025
March 1, 2025
1.1 years
May 12, 2017
March 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Estimation of incidence rates of adverse events
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 Outcomes (2)
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
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
Study Arms (1)
Notapplicable
Not applicable as non-interventional study
Interventions
Eligibility Criteria
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).
You may qualify if:
- 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
You may not qualify if:
- Patient participation in the OPUS registry
- Patient participation in any clinical trial involving Opsumit treatment or macitentan investigational product
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Actelionlead
Study Sites (106)
Pulmonary Associates
Phoenix, Arizona, 85006, United States
Cardiovascular Consultants
Phoenix, Arizona, 85032, United States
Mayo Clinic - Arizona
Phoenix, Arizona, 85054, United States
University of California San Diego
La Jolla, California, 93093, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
University of Southern California
Los Angeles, California, 90033, United States
David Geffen School of Medicine at University of California Los Angeles
Los Angeles, California, 90095-1690, United States
UCSF School of Medicine
San Francisco, California, 94143, United States
Paloma Medical Group
San Juan Capistrano, California, 92675, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105, United States
University of Colorado
Aurora, Colorado, 80045, United States
National Jewish Health
Denver, Colorado, 80206, United States
Yale University
New Haven, Connecticut, 06520, United States
Christiana Care Health Services
Newark, Delaware, 19718, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Bay Area Cardiology Associates
Brandon, Florida, 33511, United States
Florida Lung, Asthma and Sleep Specialists
Celebration, Florida, 34747, United States
Frank Hull, MD, PA
Fort Lauderdale, Florida, 33316, United States
University of Florida
Gainesville, Florida, 32610, United States
West Pasco Pulmonary Associates
Hudson, Florida, 34667, United States
Saint Vincent's Medical Center
Jacksonville, Florida, 32209, United States
Medical Research of Central Florida
Leesburg, Florida, 34748, United States
Independent Lung Associates
Melbourne, Florida, 32901, United States
University of Miami
Miami, Florida, 33136, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
Central Florida Pulmonary Group, P.A. - Downtown Orlando Office
Orlando, Florida, 32803, United States
Bassetti Medical Research Inc
Sebring, Florida, 33870, United States
Cardiovascular Medicine Associates
South Miami, Florida, 33143, United States
Coastal Pulmonary and Critical Care
St. Petersburg, Florida, 33704, United States
University of South Florida
Tampa, Florida, 33606, United States
Cleveland Clinic Florida Hospital
Weston, Florida, 33331, United States
Florida Medical Clinic
Zephyrhills, Florida, 33542, United States
Piedmont Healthcare
Austell, Georgia, 30106, United States
Southeastern Cardiology Associates
Columbus, Georgia, 31904, United States
Wellstar Marietta Pulmonary Medicine
Marietta, Georgia, 30060, United States
Bingham Memorial Hospital
Shelley, Idaho, 83274, United States
Northwestern University
Chicago, Illinois, 60611, United States
IU Health Physicians Pulmonary & Critical Care
Carmel, Indiana, 46032, United States
Lutheran Hospital
Fort Wayne, Indiana, 46804, United States
Indiana Internal Medicine Consultants
Greenwood, Indiana, 46143, United States
St. Vincent Medical Group, Inc.
Indianapolis, Indiana, 46260, United States
CIC Associates
Clive, Iowa, 50325, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
The University of Kansas Physicians
Kansas City, Kansas, 66160, United States
St. Elizabeth Healthcare Clinical Research Institute
Erlanger, Kentucky, 41018, United States
Kentuckiana Pulmonary Associates
Louisville, Kentucky, 40202, United States
LSU Health Sciences Center
New Orleans, Louisiana, 70112, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Pulmonary & Critical Care Specialists
Shreveport, Louisiana, 71105, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
Beaumont Medical Center
Troy, Michigan, 48085, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407-3799, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Saint Louis University
St Louis, Missouri, 63104, United States
Pulmonary Consultants Inc-St. Louis
St Louis, Missouri, 63136, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Nebraska Pulmonary Specialties, LLC
Lincoln, Nebraska, 68506, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-5990, United States
Barnabas Health Ambulatory Care Center
Newark, New Jersey, 07112, United States
Pulmonary and Critical Care Associates
Union, New Jersey, 07083, United States
University of New Mexico
Albuquerque, New Mexico, 87131-0001, United States
Albany Medical Center
Albany, New York, 12208, United States
Pulmonary Health Physicians
Fayetteville, New York, 13066, United States
Stony Brook University Hospital
Hauppauge, New York, 11788, United States
Temple University Hospital
Middletown, New York, 10941, United States
Winthrop University Hospital, Clinical Trials Center
Mineola, New York, 11501, United States
Mount Sinai
New York, New York, 10029, United States
Montefiore Medical Center - Bronx
The Bronx, New York, 10467, United States
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of Cincinnati
Cincinnati, Ohio, 45242, United States
Ohio State University, Wexner Medical Center
Columbus, Ohio, 43210, United States
Mount Carmel Medical Group
Columbus, Ohio, 43213, United States
Midwest Pulmonary & Sleep Research
Dayton, Ohio, 45459, United States
Southwest General Health Center
Middleburg Heights, Ohio, 44130, United States
The University of Toledo Medical Center
Toledo, Ohio, 43614, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120, United States
Oregon Health & Science University
Portland, Oregon, 97201-3098, United States
Legacy Research Institute
Portland, Oregon, 97210, United States
The Oregon Clinic
Portland, Oregon, 97225, United States
Doylestown Health Cardiology, a division of Doylestown Health Physicians
Doylestown, Pennsylvania, 18907, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
AnMed Health Medical Center
Anderson, South Carolina, 29621, United States
Carolina Cardiology Associates
Rock Hill, South Carolina, 29732, United States
Sioux Falls Cardiovascular PC
Sioux Falls, South Dakota, 57108, United States
Memorial Research Center
Chattanooga, Tennessee, 37404, United States
Mid-South Pulmonary Specialists
Memphis, Tennessee, 38157, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390-8550, United States
Premier Pulmonary CC and Sleep Medicine, PA
Denison, Texas, 75020, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Baylor Regional Medical Center at Plano
Plano, Texas, 75093, United States
Scott and White Memorial Hospital
Temple, Texas, 76508-0001, United States
University of Washington
Seattle, Washington, 98195, United States
Spokane Respiratory Consultants
Spokane, Washington, 99204-4800, United States
Cardiac Study Center
Tacoma, Washington, 98405, United States
Aurora Health Care - Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
CardioPulmonary Research Center
Guaynabo, 00968, Puerto Rico
Related Publications (5)
Melendres-Groves LD, Channick RN, Chin KM, McLaughlin VV, MacDonald G, Martin N, Ong R, Sandros M, Kim NH. Characteristics, Treatment Patterns and Outcomes of Patients with Pulmonary Arterial Hypertension by Race and Ethnicity Using Real-World Data from the Combined OPUS/OrPHeUS Studies. Adv Ther. 2025 Nov 19. doi: 10.1007/s12325-025-03403-4. Online ahead of print.
PMID: 41258625DERIVEDKim NH, Chin KM, McLaughlin VV, Ong R, MacDonald G, Martin N, Senatore A, Channick R. Macitentan and Tadalafil Combination Therapy in Patients with Pulmonary Arterial Hypertension and Cardiovascular Comorbidities: Real-World Evidence from OPUS and OrPHeUS. Adv Ther. 2025 Jul;42(7):3306-3333. doi: 10.1007/s12325-025-03180-0. Epub 2025 May 19.
PMID: 40388087DERIVEDChin KM, Channick R, Kim NH, Ong R, Turricchia S, Martin N, Mitchell L, McLaughlin VV. Macitentan in Pulmonary Arterial Hypertension Due to Congenital Heart Disease (CHD-PAH): Real-World Evidence from the OPUS/OrPHeUS Studies. Cardiol Ther. 2024 Dec;13(4):775-796. doi: 10.1007/s40119-024-00386-1. Epub 2024 Nov 25.
PMID: 39585521DERIVEDChannick R, Chin KM, McLaughlin VV, Lammi MR, Zamanian RT, Turricchia S, Ong R, Mitchell L, Kim NH. Macitentan in Pulmonary Arterial Hypertension Associated with Connective Tissue Disease (CTD-PAH): Real-World Evidence from the Combined OPUS/OrPHeUS Dataset. Cardiol Ther. 2024 Jun;13(2):315-339. doi: 10.1007/s40119-024-00361-w. Epub 2024 Mar 7.
PMID: 38451426DERIVEDKim NH, Chin KM, McLaughlin VV, DuBrock H, Restrepo-Jaramillo R, Safdar Z, MacDonald G, Martin N, Rosenberg D, Solonets M, Channick R. Safety of Macitentan for the Treatment of Portopulmonary Hypertension: Real-World Evidence from the Combined OPUS/OrPHeUS Studies. Pulm Ther. 2024 Mar;10(1):85-107. doi: 10.1007/s41030-023-00251-x. Epub 2024 Jan 7.
PMID: 38184507DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2017
First Posted
June 23, 2017
Study Start
August 3, 2017
Primary Completion
September 6, 2018
Study Completion
September 6, 2018
Last Updated
March 30, 2025
Record last verified: 2025-03