- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01028651
A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension
An Open-Label Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension
연구 개요
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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California
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Los Angeles, California, 미국, 90024
- University of California, Los Angeles
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Georgia
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Atlanta, Georgia, 미국, 30322
- Emory Univeristy
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Brigham and Women's Hospital
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Texas
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Dallas, Texas, 미국, 75235
- University of Texas, Southwestern Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
Patients must:
- Had portal hypertension.
- Be otherwise suitable candidates for OLT.
- Had severe pulmonary arterial hypertension (PAH) defined as a resting mean pulmonary arterial pressure (mPAP) >35 mmHg and pulmonary vascular resistance (PVR) ≥3 Wood Units (WU) by right heart catheterization (RHC) performed as part of standard of care evaluation within 90 days of enrollment.
- Treprostinil therapy must be recommended by the treating physician per standard of care.
- Be NYHA Functional Class II, III, or IV.
- Had pulmonary capillary wedge (PCW) pressure ≤18 mmHg and transpulmonary gradient (TPG) ≥15 mmHg.
Exclusion Criteria:
Patients must not:
- Had received any any investigational therapy as part of a clinical trial for any indication within 30 days prior to enrollment.
- Had a change in dose of treatment for PAH (bosentan [Tracleer], ambrisentan [Letairis], tadalafil [Adcirca], or sildenafil [Revatio]), within 30 days prior to enrollment. That is, subjects may have been treated with any of these agents provided the dose was stable for at least 30 days prior to enrollment.
- Had renal failure requiring hemodialysis.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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Portopulmonary hypertension
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Subjects Who Achieved Hemodynamic Parameters Appropriate for Orthotopic Liver Transplantation Candidacy at Week 24.
기간: 24 Weeks
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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).
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24 Weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24
기간: 24 weeks
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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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24 weeks
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Change in Heart Rate at Rest From Baseline to Week 24
기간: 24 weeks
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The change in heart rate was evaluated at rest from Baseline to Week 24.
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24 weeks
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Change in Cardiac Output at Rest From Baseline to Week 24
기간: 24 weeks
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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.
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24 weeks
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Change in Arterial and Venous Oxygen Saturation at Rest From Baseline to Week 24
기간: 24 weeks
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The change in arterial and venous oxygen saturation was evaluated at rest from Baseline to Week 24.
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24 weeks
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Change in Pulmonary Vascular Resistance (PVR) at Rest From Baseline to Week 24
기간: 24 weeks
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The change in pulmonary vascular resistance (PVR) was evaluated at rest from Baseline to Week 24.
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24 weeks
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Change in 6-minute Walk Distance (6MWD) From Baseline to Weeks 12 and 24.
기간: Baseline and Weeks 12 and 24
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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.
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Baseline and Weeks 12 and 24
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Change in Echocardiogram Parameters (Right Atrium and Right Ventricle Area) From Baseline to Weeks 12 and 24
기간: Baseline and Weeks 12 and 24
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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.
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Baseline and Weeks 12 and 24
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Change in Echocardiogram Parameters (Right Ventricle Diameter) From Baseline to Weeks 12 and 24
기간: Baseline and Weeks 12 and 24
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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.
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Baseline and Weeks 12 and 24
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Change in Echocardiogram Parameters (Right Ventricular Systolic Pressure) From Baseline to Weeks 12 and 24
기간: Baseline and Weeks 12 and 24
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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.
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Baseline and Weeks 12 and 24
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Change in Echocardiogram Parameters (Tricuspid Annular Plane Systolic Excursion) From Baseline to Weeks 12 and 24
기간: Baseline and Weeks 12 and 24
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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.
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Baseline and Weeks 12 and 24
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Change in Quality of Life From Baseline to Weeks 12 and 24
기간: Baseline and Weeks 12 and 24
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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.
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Baseline and Weeks 12 and 24
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Change in Plasma Brain N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Weeks 12 and 24
기간: Baseline to Weeks 12 and 24
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NT-proBNP was assessed at Baseline, Weeks 12 and 24.
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Baseline to Weeks 12 and 24
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공동 작업자 및 조사자
협력자
수사관
- 연구 책임자: Rajan Saggar, MD, University of California, Los Angeles
- 연구 책임자: Micah Fisher, MD, Emory University
- 연구 책임자: Aaron Waxman, MD, PhD, Brigham and Women's Hospital
- 연구 책임자: Sonja Bartolome, MD, UT Southwestern Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
폐동맥 고혈압에 대한 임상 시험
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University Hospital, Strasbourg, France완전한
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University of Colorado, Denver모병단심실 | 폐 혈관 저항 이상 | 대사체학 | 우수한 Cavo-Pulmonary 문합 | 엔도텔린미국
Treprostinil에 대한 임상 시험
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Insmed Incorporated완전한
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Medtronic Cardiac Rhythm and Heart FailureUnited Therapeutics빼는
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United Therapeutics모병