NCT07266519尚未招募2 期
SIRIUS - A Prospective, Non-randomized, Open-label, Proof-of-concept Study of Initial Combination Therapy With an Endothelin Receptor Antagonist, a Phosphodiesterase-5 Inhibitor and Sotatercept in Patients With Newly Diagnosed Pulmonary Arterial Hypertension A Single-arm, Multi-center, Interventional Phase II Study
Philipps University Marburg0 个研究点目标入组 25 人开始时间: 2026年7月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 主要终点
- Assessment of the effect on pulmonary vascular resistance (PVR)
研究概览
简要总结
The study aims to see how 24 weeks of triple therapy-an endothelin receptor antagonist (ERA), a phosphodiesterase-5 inhibitor (PDE5i), and sotatercept-affects pulmonary vascular resistance (PVR) in patients with newly diagnosed pulmonary arterial hypertension (PAH). SIRIUS is a 24-week, single-arm, open-label study with up to 42 days of screening and a 28-day safety follow-up. It will enroll 25 patients and will be conducted only in countries where all treatments are available and covered. After 24 weeks, PAH treatment is decided by the doctor.
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
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18- 70 years
- •Treatment-naïve patients diagnosed within 12 weeks prior to screening with I/H/D-PAH or PAH associated with corrected congenital heart disease (disease (≥12 months after correction). Patients who have received treatment with PDE5is and/or ERAs for up to 6 weeks after diagnosis are eligible provided that state-of-the-art right heart catheterization has been performed at PAH diagnosis.
- •PVR >5 WU, mPAP ≥35 mmHg and PAWP or LVEDP ≤15 mmHg at PAH diagnosis.
- •Signed written informed consent
- •Normal blood counts for platelets and erythrocytes
- •Women of childbearing potential must be willing to remain abstinent or use adequate and reliable contraception throughout the study and for at least 4 months after the last dose of study medication has been received.
- •WOCBP must use one of the following highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly - according to recommendations by the European Heads of Medicines Agencies - from at least 14 days before the first administration of study medication until 4 month after the last administration of study medication:
- •combined (estrogen and progestogen containing) hor-monal contraception associated with inhibition of ovulation:
- •intravaginal
- •transdermal
- •progestogen-only hormonal contraception associatedwith inhibition of ovulation:
- •injectable
- •implantable
- •intrauterine device (IUD)
- •intrauterine hormone-releasing system (IUS)
- •bilateral tubal occlusion
- •vasectomized partner
- •sexual abstinence
- •Male participants with female partner(s) of childbearing potential are eligible to participate in the study if they agree to the following during treatment and until 304 daysmonths after the last administration of study medication:
- •Inform any and all partner(s) of their participation in a clinical drug study and the need to comply with contraception instructions as directed by the investigator.
- •Male participants are required to use a condom during treatment and until 30 days4 months after the last administration of study medication.
- •Female partners of male participants who have not undergone a vasectomy with the absence of sperm confirmed or a bilateral orchiectomy should consider use of effective methods of contraception during treatment and until 30 days4 months after the last administration of study medication.
- •Sperm donation is not allowed during treatment and until 4 months after the last administration of study medication.
排除标准
- •Other Forms of PH or PAH
- •Use of PAH medications for more than 6 weeks prior to screening
- •Symptoms or signs of clinically relevant lung disease, including TLC < 70%, FEV1/FVC <60%, and DLCO <45%, respectively
- •Signs of left heart failure with reduced or preserved ejection fraction, including LVEF <50%, LAVI >34 ml/m2, E/é ≥15, or permanent atrial fibrillation, respectively.
- •History of severe bleeding/haemorrhage
- •Therapy with prostacyclin and/or antithrombotic agents
- •eGFR <30 ml/min/m
- •Pregnancy or breastfeeding
- •Hypersensitivity to the active substance or to any of the excipients
研究组 & 干预措施
Single arm
Experimental
Treatment arm
干预措施: Sotatercept 0.3 mg/kg escalating to 0.7 mg/kg (Drug)
Single arm
Experimental
Treatment arm
干预措施: Sotatercept (Drug)
结局指标
主要结局
Assessment of the effect on pulmonary vascular resistance (PVR)
时间窗: 24 weeks
Change in PVR from screening at week 24 after 6-months of treatment with triple combination therapy in PAH patients
次要结局
未报告次要终点
研究者
相似试验
进行中（未招募）
2 期
A Study to Evaluate the Safety,Tolerability,Pharmacokinetics and Pharmacodynamics of Cenerimod in Adult Chinese Participants With Moderate-to-severe Systemic Lupus Erythematosus (SLE)NCT07266090Viatris Pharmaceuticals Co., Ltd.15
已完成
4 期
This is a study to evaluate dose-flexibility of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis2023-504869-23-00AbbVie Deutschland GmbH & Co. KG272
招募中
3 期
A Study to Select a Dose Regimen (Part A) and to Investigate Overall Survival (Part B) With Nanvuranlat Compared With Physician's Best Choice in Participants Aged 18 Years or Older With Biliary Tract CancerNCT07265674J-Pharma Co., Ltd.480
招募中
2 期
A Trial of SHR-7787 Injection Combined With Other Anti-tumor Drugs in Patients With Malignant Solid TumorsNCT07268040Shanghai Hengrui Pharmaceutical Co., Ltd.400
尚未招募
1 期
A Study of HY001N in the Treatment of Relapsed or Refractory Neurological Autoimmune DiseasesNCT07265206Juventas Cell Therapy Ltd.15