ACTRN12619001178134终止2 期
A Dose Escalation Study to Evaluate the Effect of RT234 on Cardiopulmonary Haemodynamics in Subjects with Pulmonary Arterial Hypertension.
Respira Therapeutics Australia Pty Ltd0 个研究点目标入组 14 人开始时间: 2019年8月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1. Diagnosis of RHC-confirmed WHO Group 1 PAH in any of the following three categories:
- •a) Idiopathic, primary or familial pulmonary arterial hypertension (IPAH, PPH, or FPAH);
- •b) PAH associated with one of the following connective tissue diseases (CTD):
- •i) Systemic sclerosis (scleroderma)
- •ii) Limited scleroderma
- •iii) Mixed connective tissue disease
- •iv) Systemic lupus erythematosus
- •v) Overlap syndrome;
- •c) PAH associated with:
- •i) Human immunodeficiency virus (HIV) infection with no evidence of opportunistic infection in the preceding 6 months;
- •ii) Simple, congenital systemic-to-pulmonary shunts at least one-year post-surgical repair.
- •iii) Exposure to legal drugs, chemicals and toxins, such as fenfluramine, derivatives, other anorexigens, toxic rapeseed oil or L-tryptophan.
- •2. Previously diagnosed with PAH but with the following conditions:
- •a) Stable PAH without significant adjustments of disease-specific background PAH therapy, at least 3 months prior to RHC procedure;
- •b) If on corticosteroids, has been receiving a stable dose of less than or equal to 20 mg/day of prednisone (or equivalent dose of other corticosteroid) for at least 30 days prior to RHC procedure.
- •3. Pulmonary Function Tests (PFT) within 24 months prior to RHC procedure that fulfill the following criteria:
- •a) Forced Expiratory volume in one second (FEV1) greater than or equal to 70% predicted (pre-bronchodilators);
- •b) FEV1/forced expiratory vital capacity (FVC) greater than or equal to 70% and less than or equal to 90% (pre-bronchodilators);
- •c) FVC greater than or equal to 70% predicted.
- •4. Females of childbearing potential must have a negative pregnancy test at Screening, Day 1 and Day 15
- •5. Females not of childbearing potential must be post-menopausal (defined as cessation of regular menstrual periods for at least 12 months) or have documented evidence of surgical sterilization at least 6 months prior to Screening.
排除标准
- •1. Baseline systemic hypotension, defined as MAP <50 mmHg or systolic blood pressure (SBP) <90 mmHg at Screening
- •2. Requirement of intravenous inotropes within 30 days prior to RHC procedure
- •3. Use of oral, topical or inhaled nitrates within 2 weeks prior to RHC procedure
- •4. Uncontrolled systemic hypertension: SBP >160 mmHg or diastolic blood pressure (DBP) >100 mmHg during Screening
- •5. History of portal hypertension or chronic liver disease, including active viral replication of hepatitis B and/or hepatitis C, or classified as having moderate to severe hepatic impairment (Child-Pugh Class B-C)
- •6. Chronic renal insufficiency as defined by serum creatinine >2.5 mg/dL at Screening or requires dialysis
- •7. History of atrial septostomy
- •8. Unrepaired congenital heart disease
- •9. Pericardial constriction; restrictive or congestive cardiomyopathy
- •10. History of left ventricular ejection fraction (EF) < 40%
- •11. Symptomatic coronary disease with demonstrable ischemia
- •12. Poorly controlled asthma
- •13. Clinically significant intercurrent illness or surgery within 30 days of Day 1
- •14. Known or suspected hypersensitivity or allergic reaction to vardenafil
- •Clinical RHC <2 weeks from Screening
- •15. History of non-arteritic anterior ischemic optic neuropathy (NAION) or retinitis pigmentosa
- •16. QTcF) >450 msec on an electrocardiogram (ECG) at Screening.
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