JPRN-jRCT2021230022招募中2 期
A phase II investigator-initiated clinical trial of PAI-1 inhibitor (TM5614) for systemic sclerosis-associated interstitial lung disease under immunosuppressive treatment
Asano Yoshihide0 个研究点目标入组 50 人开始时间: 2023年9月6日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
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
- >= 18age old 至 ot applicable（—）
入选标准
- •1. Patients 18 years of age or older with written consent
- •2. Patients with systemic sclerosis who meet the 2013 ACR/EULAR classification criteria for systemic sclerosis
- •3. Within 7 years of the onset of systemic sclerosis (first appearance of systemic sclerosis-related symptoms other than Raynaud's phenomenon)
- •4. Interstitial lung disease associated with systemic sclerosis confirmed by high-resolution CT performed within 12 months, and lung involvement greater than 10% in extent
- •5. %FVC of 40% or more
- •6. %DLco of 30% or more but less than 90%
- •7. No oral administration of PSL 10 mg/day or more within 2 weeks prior to obtaining consent (less than 10 mg/day during the study period, dose cannot be increased)
- •8. No treatment with antifibrotic drugs or tocilizumab within 4 weeks
- •9. Not receiving rituximab treatment within 6 months
- •10. Receiving immunosuppressive drugs (azathioprine, cyclophosphamide, or mycophenolate mofetil) at least 6 months prior to the date of consent, mycophenolate mofetil at least 3 months prior to the date of consent, and no dose change of mycophenolate mofetil within 3 months
排除标准
- •1. Patients with an estimated right ventricular systolic pressure greater than 35 mmHg on echocardiography performed within 12 months prior to enrollment, or with pulmonary arterial hypertension requiring treatment
- •2. Patients with FEV1/FVC less than 0.7
- •3. Patients with AST, ALT, or bilirubin exceeding 1.5 times the upper limit of the institutional reference value
- •4. Patients with creatinine clearance (Cockcroft-Gault method) less than 30 mL/min
- •5. Patients with poorly controlled hypertension (systolic pressure of 160 mmHg or more, or diastolic pressure of 100 mmHg or more)
- •6. Patients with a history of myocardial infarction or unstable angina pectoris within 6 months prior to obtaining consent
- •7. Patients with chronic liver failure
- •8. Patients with a history of serious trauma or surgery within 3 months prior to consent
- •9. Patients on anticoagulation therapy
- •10. Patients receiving more than 3 antiplatelet agents
- •11. Patients with a history of bleeding within 6 months prior to obtaining consent
- •12. Patients with a PT-INR greater than 2 and an APTT greater than 1.5 times the upper limit of the institutional standard
- •13. Patients with a history of thromboembolism within 1 year prior to obtaining consent
- •14. Patients with clinical signs of malabsorption or need for central venous nutrition
- •15. Patients who have participated in another clinical trial or clinical study within the past 6 months and have received any drug, or are currently participating in another clinical trial or clinical study
- •16. Patients who are pregnant, lactating, or planning to become pregnant
- •17. Female patients of childbearing age who are unable to use effective contraception from the date of consent until 3 months after completion of the study
- •18. Patients with a history of scleroderma renal crisis
- •19. Other patients who are judged by the investigator (subinvestigator) to be ineligible for this clinical trial.
研究者
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