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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
| Brigham and Women's Hospital | OTHER |
| University of Texas | OTHER |
| Emory University |
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This was a multicenter, prospective, observational, open-label study. Patients meeting inclusion/exclusion criteria received treatment with treprostinil as recommended by their treating physicians and were followed according to standard of care. This observational study collected clinical data and biologic specimens from patients who were treated for portopulmonary hypertension (PoPH), with a goal of achieving hemodynamic parameters appropriate for orthotopic liver transplantation candidacy, including mean pulmonary arterial pressure (mPAP) less than 35 mmHg and pulmonary vascular resistance (PVR) less than 3 Wood-units (WU) at Week 24 in patients with severe PoPH.
Treprostinil is approved as a continuous subcutaneous (SC) or intravenous (IV) infusion by the FDA for the treatment of WHO group I PAH with New York Heart Association (NYHA) Functional Class II, III or IV symptomatology. To date, treprostinil has not been studied in the setting of PoPH; however, it is commonly prescribed in this setting. This was an observational, open-label, multicenter study which documented the safety and efficacy profile of this agent in PoPH to facilitate orthotopic liver transplantation (OLT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Portopulmonary hypertension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treprostinil | Drug | Remodulin is supplied in concentrations of 1, 2.5 , 5, and 10 mg/mL and can be administered as supplied or diluted for intravenous (IV) infusion prior to administration. Remodulin is indicated for subcutaneous (SC) or IV use only as a continuous infusion. Remodulin is preferably infused subcutaneously, but can be administered by a central IV line if the SC route is not tolerated. The infusion rate is initiated at 1.25 ng/kg/min. If this initial dose cannot be tolerated because of systemic effects, the infusion rate should be reduced to 0.625 ng/kg/min. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Achieved Hemodynamic Parameters Appropriate for Orthotopic Liver Transplantation Candidacy at Week 24. | The primary efficacy endpoint was the number of subjects who achieved a mean pulmonary arterial pressure (mPAP) less than 35 mmHg and a pulmonary vascular resistance (PVR) less than 3 Wood units (WU) at Week 24 in patients with severe portopulmonary hypertension (PoPH). | 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24 | The change in hemodynamic parameters (including systolic pulmonary arterial pressure [PAPs], diastolic pulmonary arterial pressure [PAPd], mean pulmonary arterial pressure [mPAP], and transpulmonary gradient [TPG]) was evaluated at rest from Baseline to Week 24. The median change in hemodynamic parameters from Baseline to Week 24 via right-heart catheterization (RHC) is presented. |
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Inclusion Criteria:
Patients must:
Exclusion Criteria:
Patients must not:
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Subjects were recruited from 4 liver transplantation centers in the US, referred for portopulmonary hypertension.
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| Name | Affiliation | Role |
|---|---|---|
| Rajan Saggar, MD | University of California, Los Angeles | Study Director |
| Micah Fisher, MD | Emory University | Study Director |
| Aaron Waxman, MD, PhD | Brigham and Women's Hospital | Study Director |
| Sonja Bartolome, MD | University of Texas Southwestern Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90024 | United States | ||
| Emory Univeristy |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treprostinil Injection | Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| OTHER |
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|
|
| 24 weeks |
| Change in Heart Rate at Rest From Baseline to Week 24 | The change in heart rate was evaluated at rest from Baseline to Week 24. | 24 weeks |
| Change in Cardiac Output at Rest From Baseline to Week 24 | The change in cardiac output was evaluated at rest from Baseline to Week 24. The median change in cardiac output from Baseline to Week 24 is presented. | 24 weeks |
| Change in Arterial and Venous Oxygen Saturation at Rest From Baseline to Week 24 | The change in arterial and venous oxygen saturation was evaluated at rest from Baseline to Week 24. | 24 weeks |
| Change in Pulmonary Vascular Resistance (PVR) at Rest From Baseline to Week 24 | The change in pulmonary vascular resistance (PVR) was evaluated at rest from Baseline to Week 24. | 24 weeks |
| Change in 6-minute Walk Distance (6MWD) From Baseline to Weeks 12 and 24. | The 6-Minute Walk Test was conducted at Screening, Baseline prior to starting study drug and at least 24 hours after the Screening test, and during the Treatment Phase at Weeks 12 and 24. | Baseline and Weeks 12 and 24 |
| Change in Echocardiogram Parameters (Right Atrium and Right Ventricle Area) From Baseline to Weeks 12 and 24 | Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24. | Baseline and Weeks 12 and 24 |
| Change in Echocardiogram Parameters (Right Ventricle Diameter) From Baseline to Weeks 12 and 24 | Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24. | Baseline and Weeks 12 and 24 |
| Change in Echocardiogram Parameters (Right Ventricular Systolic Pressure) From Baseline to Weeks 12 and 24 | Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24. | Baseline and Weeks 12 and 24 |
| Change in Echocardiogram Parameters (Tricuspid Annular Plane Systolic Excursion) From Baseline to Weeks 12 and 24 | Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24. | Baseline and Weeks 12 and 24 |
| Change in Quality of Life From Baseline to Weeks 12 and 24 | The 36-item Short Form Survey (SF-36) is a health related quality of life instrument, which measures dimensions of physical and social roles and functioning, mental health, vitality, and pain. Items are scored on a 0 to 100 range so that the lowest scores represent the highest disability. The quality of life assessment was conducted at Baseline and Weeks 12 and 24 and the change from Baseline to Weeks 12 and 24 is presented. | Baseline and Weeks 12 and 24 |
| Change in Plasma Brain N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Weeks 12 and 24 | NT-proBNP was assessed at Baseline, Weeks 12 and 24. | Baseline to Weeks 12 and 24 |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Texas, Southwestern Medical Center | Dallas | Texas | 75235 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treprostinil Injection | Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Who Achieved Hemodynamic Parameters Appropriate for Orthotopic Liver Transplantation Candidacy at Week 24. | The primary efficacy endpoint was the number of subjects who achieved a mean pulmonary arterial pressure (mPAP) less than 35 mmHg and a pulmonary vascular resistance (PVR) less than 3 Wood units (WU) at Week 24 in patients with severe portopulmonary hypertension (PoPH). | The total number of subjects enrolled and analyzed. | Posted | Number | participants | 24 Weeks |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24 | The change in hemodynamic parameters (including systolic pulmonary arterial pressure [PAPs], diastolic pulmonary arterial pressure [PAPd], mean pulmonary arterial pressure [mPAP], and transpulmonary gradient [TPG]) was evaluated at rest from Baseline to Week 24. The median change in hemodynamic parameters from Baseline to Week 24 via right-heart catheterization (RHC) is presented. | All subjects with data available at Baseline and Week 24 | Posted | Median | Full Range | mmHg | 24 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Heart Rate at Rest From Baseline to Week 24 | The change in heart rate was evaluated at rest from Baseline to Week 24. | All subjects with data available at Baseline and Week 24 | Posted | Median | Full Range | beats/min | 24 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Cardiac Output at Rest From Baseline to Week 24 | The change in cardiac output was evaluated at rest from Baseline to Week 24. The median change in cardiac output from Baseline to Week 24 is presented. | All subjects with data available at Baseline and Week 24 | Posted | Median | Full Range | L/min | 24 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Arterial and Venous Oxygen Saturation at Rest From Baseline to Week 24 | The change in arterial and venous oxygen saturation was evaluated at rest from Baseline to Week 24. | All subjects with data available at Baseline and Week 24 | Posted | Median | Full Range | percentage bound to hemoglobin | 24 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Pulmonary Vascular Resistance (PVR) at Rest From Baseline to Week 24 | The change in pulmonary vascular resistance (PVR) was evaluated at rest from Baseline to Week 24. | All subjects with data available at Baseline and Week 24 | Posted | Median | Full Range | Wood Units | 24 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change in 6-minute Walk Distance (6MWD) From Baseline to Weeks 12 and 24. | The 6-Minute Walk Test was conducted at Screening, Baseline prior to starting study drug and at least 24 hours after the Screening test, and during the Treatment Phase at Weeks 12 and 24. | All subjects with data available at Baseline and Weeks 12 and 24 | Posted | Median | Full Range | Meters | Baseline and Weeks 12 and 24 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Echocardiogram Parameters (Right Atrium and Right Ventricle Area) From Baseline to Weeks 12 and 24 | Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24. | All subjects with data available at Baseline and Weeks 12 and 24. | Posted | Median | Full Range | cm2 | Baseline and Weeks 12 and 24 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Echocardiogram Parameters (Right Ventricle Diameter) From Baseline to Weeks 12 and 24 | Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24. | All subjects with data available at Baseline and Weeks 12 and 24. | Posted | Median | Full Range | mm | Baseline and Weeks 12 and 24 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Echocardiogram Parameters (Right Ventricular Systolic Pressure) From Baseline to Weeks 12 and 24 | Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24. | All subjects with data available at Baseline and Weeks 12 and 24. | Posted | Median | Full Range | mmHg | Baseline and Weeks 12 and 24 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Echocardiogram Parameters (Tricuspid Annular Plane Systolic Excursion) From Baseline to Weeks 12 and 24 | Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24. | All subjects with data available at Baseline and Weeks 12 and 24. | Posted | Median | Full Range | cm | Baseline and Weeks 12 and 24 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Quality of Life From Baseline to Weeks 12 and 24 | The 36-item Short Form Survey (SF-36) is a health related quality of life instrument, which measures dimensions of physical and social roles and functioning, mental health, vitality, and pain. Items are scored on a 0 to 100 range so that the lowest scores represent the highest disability. The quality of life assessment was conducted at Baseline and Weeks 12 and 24 and the change from Baseline to Weeks 12 and 24 is presented. | All subjects with data available at Baseline and Weeks 12 and 24. | Posted | Median | Full Range | units on a scale | Baseline and Weeks 12 and 24 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Plasma Brain N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Weeks 12 and 24 | NT-proBNP was assessed at Baseline, Weeks 12 and 24. | All subjects with data available at Baseline and Weeks 12 and 24. | Posted | Median | Full Range | pg/mL | Baseline to Weeks 12 and 24 |
|
|
Adverse events were recorded throughout the 24-week study as well as for 4 weeks after completion of the final visit.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treprostinil Injection | Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH). | 8 | 13 | 13 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic hepatic failure | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Anaemia macrocytic | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hepatorenal syndrome | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Infusion site cellulitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Infusion site pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Infusion site pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Infusion site infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Abdominal distention | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Blood uric acide increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cataract operation | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Device leakage | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dyspepsia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hepatic lesion | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Infusion site erythema | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Infusion site vesicles | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
Institution and/or Principal Investigator agree not to publish or publicly present any interim results of the Study without the prior written consent of Sponsor, not to be unreasonably withheld or delayed, except as provided below. Institution and/or Principal Investigator further agree to provide Sponsor with drafts of any such publication or presentation for review and approval no less than 30 days prior to submission for publication or the date of public presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Laliberte, PharmD | United Therapeutics Corp. | 919-425-8176 | KLaliberte@unither.com |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C427248 | treprostinil |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Mixed venous oxygen saturation (%) |
| |||||
| Arterial oxygen saturation (%) |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Change from Baseline to Week 12 |
| |||||
| Change from Baseline to Week 24 |
|