Trial · NCT01028651
A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension
NCT01028651, Completed, United Therapeutics; results first posted 2017-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension. Trials, record NCT01028651. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01028651
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension
- NCT number
- NCT01028651
- Status
- Completed
- Enrollment
- 13 participants, actual
- Lead sponsor
- United Therapeutics
- Conditions
- Portopulmonary Hypertension, Pulmonary Arterial Hypertension, Pulmonary Hypertension
- Interventions
- Treprostinil
- First posted
- 2009-12-09
- Last updated
- 2017-02-24
- Results first posted
- 2017-02-24
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Who Achieved Hemodynamic Parameters Appropriate for Orthotopic Liver Transplantation Candidacy at Week 24. | 24 Weeks | 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). |
| Secondary | Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24 | 24 weeks | 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. |
| Secondary | Change in Heart Rate at Rest From Baseline to Week 24 | 24 weeks | The change in heart rate was evaluated at rest from Baseline to Week 24. |
| Secondary | Change in Cardiac Output at Rest From Baseline to Week 24 | 24 weeks | 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. |
| Secondary | Change in Arterial and Venous Oxygen Saturation at Rest From Baseline to Week 24 | 24 weeks | The change in arterial and venous oxygen saturation was evaluated at rest from Baseline to Week 24. |
| Secondary | Change in Pulmonary Vascular Resistance (PVR) at Rest From Baseline to Week 24 | 24 weeks | The change in pulmonary vascular resistance (PVR) was evaluated at rest from Baseline to Week 24. |
| Secondary | Change in 6-minute Walk Distance (6MWD) From Baseline to Weeks 12 and 24. | Baseline and 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. |
| Secondary | Change in Echocardiogram Parameters (Right Atrium and Right Ventricle Area) From Baseline to Weeks 12 and 24 | Baseline and 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. |
| Secondary | Change in Echocardiogram Parameters (Right Ventricle Diameter) From Baseline to Weeks 12 and 24 | Baseline and 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. |
| Secondary | Change in Echocardiogram Parameters (Right Ventricular Systolic Pressure) From Baseline to Weeks 12 and 24 | Baseline and 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Who Achieved Hemodynamic Parameters Appropriate for Orthotopic Liver Transplantation Candidacy at Week 24. | 24 Weeks | The total number of subjects enrolled and analyzed. | participants | NUMBER |
| SECONDARY | Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24 | 24 weeks | All subjects with data available at Baseline and Week 24 | mmHg | MEDIAN |
| SECONDARY | Change in Heart Rate at Rest From Baseline to Week 24 | 24 weeks | All subjects with data available at Baseline and Week 24 | beats/min | MEDIAN |
| SECONDARY | Change in Cardiac Output at Rest From Baseline to Week 24 | 24 weeks | All subjects with data available at Baseline and Week 24 | L/min | MEDIAN |
| SECONDARY | Change in Arterial and Venous Oxygen Saturation at Rest From Baseline to Week 24 | 24 weeks | All subjects with data available at Baseline and Week 24 | percentage bound to hemoglobin | MEDIAN |
| SECONDARY | Change in Pulmonary Vascular Resistance (PVR) at Rest From Baseline to Week 24 | 24 weeks | All subjects with data available at Baseline and Week 24 | Wood Units | MEDIAN |
| SECONDARY | Change in 6-minute Walk Distance (6MWD) From Baseline to Weeks 12 and 24. | Baseline and Weeks 12 and 24 | All subjects with data available at Baseline and Weeks 12 and 24 | Meters | MEDIAN |
| SECONDARY | Change in Echocardiogram Parameters (Right Atrium and Right Ventricle Area) From Baseline to Weeks 12 and 24 | Baseline and Weeks 12 and 24 | All subjects with data available at Baseline and Weeks 12 and 24. | cm2 | MEDIAN |
| SECONDARY | Change in Echocardiogram Parameters (Right Ventricle Diameter) From Baseline to Weeks 12 and 24 | Baseline and Weeks 12 and 24 | All subjects with data available at Baseline and Weeks 12 and 24. | mm | MEDIAN |
| SECONDARY | Change in Echocardiogram Parameters (Right Ventricular Systolic Pressure) From Baseline to Weeks 12 and 24 | Baseline and Weeks 12 and 24 | All subjects with data available at Baseline and Weeks 12 and 24. | mmHg | MEDIAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Who Achieved Hemodynamic Parameters Appropriate for Orthotopic Liver Transplantation Candidacy at Week 24. | Treprostinil Injection | Primary endpoint achieved | 1 | participants | |
| Number of Subjects Who Achieved Hemodynamic Parameters Appropriate for Orthotopic Liver Transplantation Candidacy at Week 24. | Treprostinil Injection | Primary endpoint not achieved | 12 | participants | |
| Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24 | Treprostinil Injection | Mean pulmonary arterial pressure (mmHg) | -3.8 | Full Range -26 to 1 | mmHg |
| Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24 | Treprostinil Injection | Systolic pulmonary arterial pressure (mmHg) | -2.0 | Full Range -46 to 1 | mmHg |
| Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24 | Treprostinil Injection | Diastolic pulmonary arterial pressure (mmHg) | -4.0 | Full Range -22 to 1 | mmHg |
| Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24 | Treprostinil Injection | Mean right arterial pressure (mmHg) | -2.0 | Full Range -9 to 5 | mmHg |
| Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24 | Treprostinil Injection | Mean systemic arterial pressure (mmHg) | -0.7 | Full Range -28 to 34.7 | mmHg |
| Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24 | Treprostinil Injection | Systolic systemic arterial pressure (mmHg) | 7.0 | Full Range -44 to 94 | mmHg |
| Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24 | Treprostinil Injection | Diastolic systemic arterial pressure | 0 | Full Range -20 to 35 | mmHg |
| Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24 | Treprostinil Injection | Mean pulmonary capillary wedge pressure (mmHg) | 0 | Full Range -3 to 8 | mmHg |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treprostinil Injection | 13 | |
| Overall Study | COMPLETED | Treprostinil Injection | 10 | |
| Overall Study | NOT COMPLETED | Treprostinil Injection | 3 |
Source ClinicalTrials.gov
Adverse events92
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Treprostinil Injection | 10 | 13 | 10 |
| other | Headache | Nervous system disorders | Treprostinil Injection | 8 | 13 | 10 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Treprostinil Injection | 7 | 13 | 7 |
| other | Vomiting | Gastrointestinal disorders | Treprostinil Injection | 7 | 13 | 9 |
| other | Infusion site pain | General disorders | Treprostinil Injection | 5 | 13 | 7 |
| other | Pain in jaw | Musculoskeletal and connective tissue disorders | Treprostinil Injection | 6 | 13 | 6 |
| other | Decreased appetite | Metabolism and nutrition disorders | Treprostinil Injection | 4 | 13 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | Treprostinil Injection | 4 | 13 | 6 |
| other | Urinary tract infection | Infections and infestations | Treprostinil Injection | 3 | 13 | 8 |
| other | Infusion site infection | Infections and infestations | Treprostinil Injection | 3 | 13 | 4 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treprostinil Injection | ||
| Total, other adverse events | Treprostinil Injection | 13 | 13 |
| Total, serious adverse events | Treprostinil Injection | 8 | 13 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01028651
GET https://conductscience.org/api/trials/v1/NCT01028651/results?page=2