EUCTR2018-001187-33-CZ进行中（未招募）1 期
A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients (ADVANCE Outcomes) - ADVANCE-Outcomes
nited Therapeutics Corporation0 个研究点目标入组 1,000 人开始时间: 2018年12月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Each subject must meet ALL of the following inclusion criteria to be eligible for enrollment into the study:
- •1. At least 18 years of age
- •2. Evidence of a personally signed and dated Informed Consent Form indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures.
- •3. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •4. Primary diagnosis of symptomatic PAH classified by one of the following subgroups:
- •a. Idiopathic pulmonary arterial hypertension;
- •b. Heritable pulmonary arterial hypertension;
- •c. Drug or toxin induced based on prior exposure to drugs, chemicals, or toxins, such as fenfluramine derivatives, other anorexigens, toxic rapeseed oil, or L-tryptophan.
- •d. PAH associated with: Connective tissue disease (CTD), HIV infection; Congenital systemic-pulmonary intracardiac shunt (must have undergone surgical correction or repair with a closure device at least 1 year prior to Screening and have no, or a clinically
- •insignificant, shunt fraction [1.0 =pulmonary-systemic flow ratio =1.5] in the opinion of the Investigator.
- •5. Has had a right heart catheterization (RHC) performed at or within 3 years prior to Screening (RHC will be performed during Screening if not available) that is consistent with the diagnosis of PAH, meeting all of the following criteria:
- •a. Mean pulmonary arterial pressure (mPAP) =20 mmHg (at rest)
- •b. PAWP =15 mmHg (if PAWP cannot be reliably attained, then left ventricular end diastolic pressure =15 mmHg)
- •c. PVR >2.00 Wood units (>160 dynes/sec/cm5).
- •6. Has WHO/NYHA functional class II to IV symptoms.
- •7. If on PAH-specific background oral therapy, subject is on stable therapy with either an endothelin receptor antagonist (ERA) and/or a PDE5-I or a soluble guanylate cyclase (sGC) stimulator. Subjects must have access to locally available standard of care treatment in accordance with national guidelines
- •a. Stable is defined as no change in dose or regimen within 30 days prior to Baseline and for the duration of the study.
- •b. Subjects may be on either a PDE5 inhibitor or an sGC at stable dose (but not both).
- •c. If the subject’s disease-specific PAH therapy does not include a PDE-5 inhibitor, the use of PDE5-I for erectile dysfunction, up to 3 doses per week, is permitted.
- •8. Has a 6MWD of =150 meters.
- •9. If the subject is taking concomitant medications that may affect the clinical manifestations of PAH (e.g., calcium channel blockers, diuretics, digoxin, or L-arginine supplementation, beta blockers, angiotensin-converting enzyme inhibitors, or angiotensin II receptor blockers), the subject must be on a stable dose for at least 30 days prior to the Baseline Visit and the dosage mainta, beta
- •blockers, angiotensin-converting enzyme inhibitors, or angiotensin II receptor blockers), the
- •subject must be on a stable dose for at least 30 days prior to the Baseline Visit and the dosage
- •maintained throughout the study. The exception is that the dose of diuretics must be stable for
- •at least the 10 days prior to Baseline.
- •10. Both male and female subjects agree to use a highly effective method of birth control throughout the entire study period from informed consent through the 30-Day Follow-up Visit, if the possibility of conception exists. Eligible male and female subjects must also agree not to participate in a conception process (ie, actively attempt to bec
排除标准
- •Subjects must not meet ANY of the following exclusion criteria to be eligible for enrollment into the study, unless otherwise indicated:
- •1. For subjects with known HIV-associated PAH, a cluster designation 4 T-cell count <200/mm3 within 90 days of Baseline.
- •2. Subjects must not have 3 or more of the following left ventricular dysfunction risk factors:
- •a. Body mass index =30 kg/m2
- •b. History of systemic hypertension
- •c. Diabetes mellitus – any type
- •d. Historical evidence of significant coronary artery disease established by any 1 of the following: History of myocardial infarction or percutaneous coronary intervention or angiographic evidence of coronary artery disease (>50% stenosis in at least 1 coronary artery); Positive stress test with imaging; Previous coronary artery bypass graft; angina
- •e. Recurrent or persistent atrial fibrillation.
- •3. Has evidence of more than mild lung disease on PFTs performed within 180 days prior to, or during Screening. Subjects with any of the following criteria will be excluded:
- •a. Forced expiratory volume in 1 second <60% (predicted); or
- •b. Total lung capacity (TLC) <60% (predicted)
- •4. Has evidence of thromboembolic disease as determined by a V/Q lung scan or other local standard of care diagnostic evaluation at or after diagnosis of PAH.
- •5. Current diagnosis of ongoing and clinically significant sleep apnea as defined by the Investigator.
- •6. Male subjects with a corrected QT interval using Fridericia’s formula (QTcF) >450 msec and female subjects with a QTcF >470 msec on ECG recorded at Screening and analyzed by the central ECG laboratory. Subjects with evidence of intraventricular conduction delay (IVCD). In the presence of IVCD, subjects, defined as a QRS interval greater than 110 msec, will be excluded if the QTcF is
- •>500 msec for both males and females.
- •7. Severe chronic liver disease (i.e., Child-Pugh Class C), portal hypertension, cirrhosis or complications of cirrhosis/portal hypertension (e.g., history of variceal hemorrhage, encephalopathy).
- •8. Confirmed active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
- •9. Subjects with alanine aminotransferase or aspartate aminotransferase =3 times the upper limit of normal (ULN) or total bilirubin =2 × ULN at Screening.
- •10. Chronic renal insufficiency as defined by serum creatinine >2.5 mg/dL or requiring dialysis at Screening.
- •11. Hemoglobin concentration <9 g/dL at Screening.
- •12. Subjects treated with an IV or SC prostacyclin pathway agent (e.g., epoprostenol, treprostinil, or iloprost) for PAH at any time prior to Baseline (use in vasoreactive testing is permitted).
- •13. Subjects currently on or who were treated with an inhaled or oral prostacyclin pathway agent (iloprost, treprostinil, beraprost, or selexipag) for >6 months or within 90 days prior to Baseline.
- •Subject is not eligible if treatment was stopped for a safety or tolerability issue related
- •to systemic prostacyclin adverse effects at any time. If a subject discontinued for other reasons, the subject may be eligible if the subject has been off therapy and stable (i.e., no change in WHO/NYHA FC or change in PAHspecific background oral therapy) for at least 90 days prior to Baseline.
- •14. Subject has pulmonary veno-occlusive disease.
- •15. Malignancy diagnosed and/or treated within 5 years prior to Screening, with the exception of localized non-metastatic basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix excised with curative intent.
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