NL-OMON54562招募中3 期
A Study Evaluating the Efficacy and Safety of Ralinepag To Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes ROR-PH-301 (APD811-301)
nited Therapeutics Corporation0 个研究点目标入组 4 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 4
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
- 年龄范围
- 18 至 99（—）
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
- •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, angiotensinconverting
- •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
- 另有 8 项未显示
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;
- •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
- •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
- 另有 7 项未显示
研究者
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