EUCTR2019-001361-33-GB进行中（未招募）1 期
A Randomised, Double-blind, Placebo-controlled Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of CYP-002 in Adults with Critical Limb Ischaemia who are Unsuitable for Revascularisation
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Prospective participants must meet all of the following inclusion criteria to be eligible to participate in the study:
- •1. Provide written informed consent.
- •2. Male or female, 45 years of age or older.
- •3. Diagnosed with CLI, Rutherford Category 5.
- •4. At least one of the following findings in the index leg:
- •a. ABI of less than 0.5.
- •b. Ankle pressure of less than 60 mmHg.
- •c. A measurable toe pressure of less than 40 mmHg.
- •d. In cases where the ABI is more than 1.4 (indicating false elevation of ABI) and toe pressure is not measurable, inclusion may be based on a TcPO2 reading of less than 30 mmHg.
- •5. In the opinion of the Investigator revascularisation is not appropriate or has previously failed.
- •6. Negative urine pregnancy test at screening, if applicable (i.e. for female participants of childbearing potential).
- •7. Willing to comply with birth control measures (if applicable), to prevent female participants becoming pregnant for six months following administration of the study treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 9
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 81
排除标准
- •If prospective participants meet any of the following exclusion criteria, they are ineligible to participate in the study:
- •1. Pregnant or breastfeeding
- •2. Planning to become pregnant within six months.
- •3. Arterial insufficiency in the lower limbs known or suspected to be the result of acute limb ischaemia or an immunological, inflammatory or non-atherosclerotic disorder (e.g. Buerger's Disease, systemic sclerosis).
- •4. Undergone surgical or endovascular revascularisation of the index leg within 7 days prior to the planned administration of study treatment.
- •5. Amputation at or above the talus of the index leg.
- •6. Amputation of the index leg is already planned.
- •7. BMI > 45 kg/m2.
- •8. Systolic blood pressure =180 mmHg.
- •9. Received the SGLT2 inhibitor canagliflozin within 60 days prior to the planned administration of study treatment.
- •10. Received chemotherapy treatment within 12 months prior to the planned administration of study treatment.
- •11. Received any investigational research agent within 60 days or within five half-lives of the last treatment (if the half-life of the investigational agent is known to be longer than 12 days) prior to the planned administration of study treatment.
- •12. Require improvement of arterial inflow above the aortic bifurcation.
- •13. Experienced acute myocardial infarction, unstable angina or stroke within three months prior to screening.
- •14. Positive test for human immunodeficiency virus 1 (HIV 1), HIV 2, hepatitis B virus, Hepatitis C virus or any other infection which the opinion of the Investigator is likely to impact on the ability of the patient to participate in the study.
- •15. Active malignancy or history of malignancy within five years prior to screening (with the exception of a past history of basal or squamous cell carcinomas).
- •16. Known or suspected (in the opinion of the Investigator) alcohol or substance abuse problem.
- •17. Known sensitivity to dimethylsulfoxide (DMSO) or any other component of the study treatments.
- •18. Life expectancy of less than six months, in the opinion of the Investigator.
- •19. Any other medical or psychiatric condition which, in the opinion of the Investigator, makes the patient unsuitable for participation in the study.
研究者
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