NCT00705133已完成2 期
Using Either Intravenous (IV) or Subcutaneous (SQ) Treprostinil to Treat Pulmonary Hypertension Related to Underlying Interstitial Lung Disease
Rajan Saggar1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2008年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- 6 Minute Walk Distance
研究概览
简要总结
Our hypothesis is that IV or SQ Treprostinil can improve 6 minute walk distance, hemodynamics and quality of life in patients with interstitial lung disease and severe secondary pulmonary arterial hypertension.
详细描述
Patients with pulmonary hypertension (PH) complicating pulmonary fibrosis are at increased risk of death. There are no therapies proven to be effective in this population, targeting the pulmonary hypertension. The purpose of this study is to evaluate parenteral treprostinil in an open-label fashion in patients with pulmonary fibrosis and an advanced PH phenotype.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible subjects must have IPF and severe pulmonary arterial hypertension (PAH) documented on standard of care right-heart catheterization (RHC) and planned to receive therapy with treprostinil as recommended by the treating physician.
- •All subjects must have high resolution CT scan (HRCT) diagnostic of IPF (performed as part of standard of care evaluation) or if available, biopsy proven histological usual interstitial pneumonia (UIP).
- •Severe pulmonary arterial hypertension defined as a resting mean pulmonary artery pressure (mPAP) > 35 mm Hg; AND pulmonary vascular resistance (PVR) > 3 woods-units; AND pulmonary capillary wedge pressure (PCWP) < 18 mm Hg by right-heart catheterization (RHC) performed as part of standard of care evaluation.
- •All subjects must be planned to receive treprostinil therapy as recommended by their treating physician.
排除标准
- •Acute or chronic impairment other than dyspnea (e.g. angina pectoris, intermittent claudication) limiting the ability to perform standard of care six-minute walk tests (6MWT).
- •Six-minute walk distance (6MWD) < 50 meters at screening or baseline standard of care evaluations
- •Standard of care pulmonary function test (PFT) showing forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) ratio < 0.65
- •Standard of care pulmonary function test (PFT) showing a residual volume >120% predicted
- •Standard of care high-resolution chest computed tomography (HRCT) showing emphysema extent > 30%
- •Any investigational therapy as part of a clinical trial for any indication with 30 days before screening
- •Change in dose of treatment for IPF - investigational agent (gamma interferon-1b, pirfenidone, etanercept, and any other investigational agent intended to treat IPF), corticosteroids, or cytotoxic agents, within 30 days before screening. That is, subjects can be on any of these agents provided the dose is stable for at least 30 days prior to enrollment.
- •Current treatment for pulmonary hypertension with other prostaglandins (epoprostenol or iloprost)
- •Change in dose of treatment for PAH - (bosentan, sitaxsentan, ambrisentan, tadalafil, sildenafil, vardenafil, calcium channel blockers, nitrates, digitalis), within 30 days before screening. That is, subjects can be on any of these agents provided the dose is stable for at least 30 days prior to enrollment
- •Pulmonary rehabilitation initiated within 30 days of baseline.
研究组 & 干预措施
Treprostinil-treated
Experimental
Patients with pulmonary fibrosis with an advanced pulmonary hypertension phenotype will be treated with parenteral treprostinil in an open-label fashion
干预措施: Treprostinil (Drug)
结局指标
主要结局
6 Minute Walk Distance
时间窗: 3 months
American Thoracic Society (ATS) Practice Guideline based 6-minute walk (6MW) distance
次要结局
- Pulmonary Vascular Resistance(3 months)
- SF-36 Quality of Life(3 months)
- Brain Natriuretic Peptide(3 months)
研究者
Rajan Saggar
Principal Investigator
University of California, Los Angeles
研究点 (1)
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