JPRN-jRCT2073220002招募中2 期
Phase IIb investigator-initiated multicenter single arm study of the efficacy and safety of intravenous HUCV002-01 in patients with chronic heart failure (continuous study)
Tsutsui Hiroyuki0 个研究点目标入组 15 人开始时间: 2022年4月12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
- 15
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
- >= 20age old 至 <= 90age old（—）
- 性别
- All
入选标准
- •1) Patients enrolled in the HUCV002-01-02 study who were assigned to the standard treatment arm
- •2) Patients diagnosed with chronic heart failure
- •3) 20 years old or older, 90 years or younger at the time of informed consent
- •4) LVEF<40% by ECHO performed within 28 days before the enrollment
- •5) NYHA class II-IV, AND, no changes at least 4 weeks prior to the enrolment
- •6) BNP>=100 pg/mL, OR, NT-proBNP>=400 pg/mL
- •7) Refractory to standard medical therapy on JCS/JHFS 2021 Guideline Focused Update on Diagnosis and Treatment of Acute and Chronic Heart Failure with no clinical improvement
- •8) Patients who has ability to understand and sign the informed consent
排除标准
- •1)Chronic heart failure dues to operable valvular disease, congenital cardiac disease or coronary arterial disease
- •2)Awaiting cardiac transplant
- •3)Acute myocardial infarction within 28 days prior to the enrollment
- •4)Cerebrovascular disease within 28 days before the enrollment
- •5)Coronary artery revascularization (CABG, PCI) was performed or planned within 3 months before getting consent or during the clinical study
- •6)New treatments for cardiac failure was started within 3 months before the enrollment
- •7)Patients with malignancy or history of malignant diseases within 1 year prior to the study (Except for those who had cured carcinoma in situ or intramucosal carcinoma)
- •8)Uncontrolled hypertension (systemic BP>160mmHg or diastolic BP>100mmHg)
- •9)Symptomatic hypotension
- •10)Autoimmune disease
- •11)Any of the following within 7 days before the registration
- •a)Hepatic dysfunction: AST or ALT > ULN x3
- •b)Renal dysfunction: eGFR < 15 mL/min/1.73m^2
- •c)Platelet counts < 100 x 10^3/uL
- •d)Hb < 9.0 g/dL
- •12)Positive for any of HBV, HCV, HIV, HTLV1 or syphilis within 56 days before the enrollment
- •13)Those who has history or viral hepatitis
- •14)Patients with uncontrolled active infection
- •15)Allergic to streptomycin or gentamicin
- •16)Allergic to animals (pig, sheep, cow) or cows milk
- •17)Patient who needs systemic steroid or immunosuppressive drugs
- •18)BSA > 2.0 m^2 (Du Bois)
- •19)Functional gait disorder
- •20)Pregnant, lactating, or possible pregnant female. Female who wants to become pregnant or male who wants his partner to become pregnant. Those who refuses contraception during the study.
- •21)Those who participated in other clinical studies within 28 days prior to getting the informed consent. Those who plans to participate in other clinical studies during this study.
- •22)Patients who are taking amiodarone or have taken it in the past.
- •23)SpO2 (room air) < 93% within 28 days before the enrollment.
- •24)Patients with severe lung disease or a history of non-infectious interstitial lung disease requiring steroid therapy.
- •25)Patients whom the PI or investigators decided as inappropriate for the study.
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