CTIS2022-502378-17-00招募中1 期
A Randomized, Phase 2, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of KER-012 in Combination with Background Therapy in Adult Participants with Pulmonary Arterial Hypertension (TROPOS-Study) - KER-012-A201
Keros Therapeutics Inc.0 个研究点目标入组 90 人开始时间: 2023年9月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
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 65+（—）
- 性别
- All
入选标准
- •Adult participants = 18 years of age., Symptomatic World Health Organization (WHO) Group 1 Pulmonary Hypertension (PAH) classified by one of the following subgroups: a. Idiopathic pulmonary arterial hypertension (IPAH) b. Hereditary pulmonary arterial hypertension (HPAH) c. Associated with drugs and toxins d. PAH associated with: i. Connective tissue disease (CTD), ii. Congenital systemic-pulmonary intracardiac shunt (must have surgical correction or repair with closure device at least 1 year prior to Screening, AND have no, or clinically insignificant, shunt fraction in the opinion of Investigator [1.0 = pulmonary-systemic flow ratio = 1.5])., Has the following hemodynamic parameters that are consistent with the diagnosis of PAH: a. Mean pulmonary arterial pressure (mPAP) > 20 mmHg at rest, AND b. Pulmonary artery wedge pressure (PAWP) = 15 mmHg, AND c. PVR = 5 Wood units (400 dyn·sec·cm-5). Note: RHC to assess eligibility performed within 6 weeks from Visit 1 (Day 1)., Has WHO/New York Heart Association (NYHA) Functional Class (FC) II or III symptoms as assessed by the Investigator at Screening and Day 1., Must be on a stable PAH background therapy with either an endothelin-receptor antagonist (ERA) and/or a phosphodiesterase-5 inhibitor (PDE5-I) or soluble guanylate cyclase (sGC) stimulator and/or prostacyclin analogue or receptor agonist (oral/inhaled/SC/intravenous): a. Stable therapy is defined as no change in dose/regimen for at least 90 days prior to baseline and would be expected to be maintained for the duration of the study., 6MWD = 150 and = 500 meters repeated twice at Screening (measured at least 4 hours apart but no longer than 1 week), and both values within 15% of each other (calculated from the highest value)., Provide written (signed and dated) informed consent form before the initiation of any Screening tests or procedures. Sites in Germany, check section A7-1.2 of the study protocol.
排除标准
- •Evidence or history of left ventricular dysfunction and/or clinically significant cardiac disease., Prior participation in another interventional clinical study with medicinal products within 30 days or 5 half-lives prior to Screening, whichever is longer. Sites in France, check section A7-1.1., Has pulmonary function tests (PFTs) at Screening or within 180 days prior to the Screening with evidence of significant obstructive or parenchymal lung disease., Evidence of thromboembolic disease assessed by ventilation perfusion (V/Q) lung scan or other local standard of care diagnostic evaluation at the time of PAH diagnosis or after., Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) > 160 mmHg or sitting diastolic BP > 100 mmHg at Screening., Hemoglobin < 9 g/dL at Screening., Prior heart or heart-lung transplants, active on the lung transplant list, or life expectancy of < 12 months per Investigator assessment., Diagnosis of pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis., Initiation or discontinuation of an exercise program for cardiopulmonary rehabilitation within 90 days prior to baseline or planned initiation during the study., Prior participation in a KER-012 study, or prior treatment with a therapy targeting TGF-ß (e.g., sotatercept).
研究者
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