EUCTR2020-002788-80-DE进行中（未招募）1 期
An explorative study to assess the safety, tolerability, and efficacy of AZD4831 in the treatment of pulmonary arterial hypertension (PAH)(MPO-PAH)
niversity of Cologne0 个研究点目标入组 15 人开始时间: 2020年6月8日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed written informed consent form
- •2. Capability and willingness to comply with study procedures
- •3. Adult patients age 18–85 years (male and female)
- •4. Females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit, must not be lactating and must be of non-child-bearing potential, confirmed at the Screening Visit by fulfilling one of the following criteria:
- •a) Postmenopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and FSH levels in the postmenopausal range.
- •b) Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
- •5. Male patients must be surgically sterile or using an acceptable method of contraception (defined as barrier methods in conjunction with spermicides) for the duration of the study (from the time they sign consent) and for 3 months after the last dose of AZD4831/matching placebo to prevent pregnancy in a partner. Male patients must not donate or bank sperm during this same time
- •6. WHO Group 1 diagnosis of IPAH; HPAH; or PAH associated with connective tissue disease (CTD), drugs/toxins, HIV, repaired congenital heart defect (CHD) OR WHO group 2 diagnosis of postcapillary PH
- •7. On stable therapy (=1 approved drug) before inclusion (signed ICF) for =12 weeks, =8 weeks at same dose
- •8. Symptomatic despite therapy (WHO functional class II or III)
- •9. 6MWD =100 m at screening
- •10. Hemodynamic criteria:
- •mPAP =25 mmHg
- •PAWP or LVEDP = 15 mmHg
- •PVR > 3 Wood units
- •mPAP =25 mmHg
- •PAWP or LVEDP > 15 mmHg
- •Irrespective of PVR
- •11. No chronic thromboembolic pulmonary hypertension (CTEPH) as
- •documented by a negative or low probability lung ventilation/perfusion scan or negative pulmonary arteriogram
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1. Only for the group 1) : PAH associated with significant venous or capillary involvement (PCWP >15 mmHg), pulmonary capillary hemangiomatosis, portal hypertension or unrepaired CHD
- •2. Pulmonary hypertension belonging to WHO Groups 3–5
- •3. Uncontrolled hypertension (=160/100 mmHg), at least one value is increased
- •4. Moderate stage renal disease for patients treated with AZD4831 (eGFR <30ml/min)
- •5. Severe liver disease (Child-Pugh class C, with or without cirrhosis); elevation of liver enzymes (AST/ALT) to > 3x ULN
- •6. Hypersensitivity to the active substance or one of the ingredients (see current IB)
- •7. Participation in another interventional clinical study within 30 days before baseline
- •8. Any clinically significant disease or disorder (e.g. cardiovascular, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, psychiatric, infectious disease or major physical impairment) which, as judged by the Investigator, might put the patient at risk because of participation in the study, or probable alternative primary reason for patient's symptoms in judgment of Investigator.
- •9. Current or previous (within past 12 months) systemic fungal infection, prior screening
- •10. Patients with uncontrolled or clinically significant thyroid disease as judged by the investigator
- •11. Any ongoing skin disorder, history of or ongoing clinically significant allergy/hypersensitivity
- •12. Drug or alcohol abuse, either current or within previous 12 months
- •13. Judgement by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
- •14. Intake of strong inhibitors of CYP3A4 (i.e. itraconazole and clarithromycin) or inducers of CYP3A4 (phenytoin and rifampicin)
研究者
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