EUCTR2018-002448-10-DE进行中（未招募）1 期
An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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. Male or female patients aged 18 to 65 years.
- •2. Able to comprehend and willing to sign an informed consent form.
- •3. Diagnosis of PAH (pulmonary arterial hypertension WHO Group 1), documented by
- •right heart catheterisation with a mean pulmonary artery pressure (mPAP) = 25
- •mmHg, a pulmonary artery wedge pressure (PAWP) = 15 mmHg and a pulmonary
- •vascular resistance (PVR) > 3 WU [Galie N, et. al 2015; Lau EMT, et. al. 2017]:
- •a) Idiopathic, in non-vasoreactive patients
- •b) Heritable: Bone morphogenetic protein receptor type II (BMPR2) mutation and
- •other mutations, in non-vasoreactive patients
- •c) Drugs and toxin induced, in non-vasoreactive patients
- •d) Associated with connective tissue disease
- •e) Associated with simple congenital defects (atrial septal defect and/or ventricular
- •septal defect) if closed > 12 months before inclusion.
- •4. WHO functional class II or III as judged by the investigator.
- •5. Stable treatment with at least one of the following approved PAH therapies for at least
- •90 days prior to V1: Ambrisentan, Bosentan, Macitentan, Riociguat, Selexipag,
- •Sildenafil, Tadalafil, Epoprostenol intravenous, Iloprost inhaled or Treprostinil
- •intravenous or subcutaneous.
- •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 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Contraindication to zamicastat, i.e. known hypersensitivity to ingredients of zamicastat
- •formulation.
- •2. Two or more consecutive measurements of SBP < 95 mmHg or DBP < 50 mmHg.
- •3. Uncontrolled diabetes mellitus with HbA1c = 8.5% within the last three months or at
- •4. PAH WHO Group 1 due to portal hypertension, human immunodeficiency virus (HIV)
- •infection and schistosomiasis.
- •5. Any disease known to cause pulmonary hypertension other than PAH WHO Group 1.
- •6. Obstructive lung disease: Forced Expiratory Volume in 1 second/Forced Vital Capacity
- •(FEV1/FVC) < 60% and FEV1 < 60% of predicted value after bronchodilator
- •administration.
- •7. Restrictive lung disease: Total Lung Capacity (TLC) < 70% of predicted value.
- •8. History of moderate to severe hepatic impairment (Child-Pugh B and C).
- •9. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (measured at V1).
- •10. Use of the following prohibited medication or treatments during study participation:
- •calcium channel blockers (CCBs) if used for the treatment of PAH in vasoreactive
- •patients; drugs containing a catechol group that is metabolised by DßH e.g. rimiterole,
- •isoprenaline, dopamine, dopexamine or dobutamide or a- and/or ß-blockers.
- •11. Current or previous (within the past year) alcohol or substance abuse excluding caffeine
- •or nicotine.
- •12. Presence of any other significant or progressive/unstable medical condition that, in the
- •opinion of the investigator, would compromise evaluation of the study treatment or may
- •jeopardise the patient’s safety, compliance or adherence to protocol requirements.
- •13. For women: Pregnancy or breast-feeding. Women of childbearing potential unable or
- •unwilling to undergo pregnancy tests and practice acceptable contraceptive measures
- •from the time of informed consent until 30 days after last IMP intake. Acceptable
- •methods for women are surgical intervention (e.g. bilateral tubal occlusion), nonhormonal
- •implantable intrauterine device, double-barrier methods, true sexual abstinence
- •(i.e. when this is in line with the preferred and usual lifestyle of the patient) and
- •vasectomised partner (provided that the partner is the sole sexual partner of the patient
- •and the partner has received medical assessment of the surgical success). Periodic
- •abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), hormonal
- •contraceptives and withdrawal are not acceptable methods of contraception.
- •For men: Male patients who are sexually active with a partner of childbearing potential
- •must use, with their partner, a condom plus an approved acceptable contraceptive measure
- •from the time of informed consent until 90 days after the last IMP intake. The following
- •methods are acceptable methods of contraception: partner’s use of combined (oestrogen
- •and progestogen-containing) hormonal contraception associated with inhibition of
- •ovulation (oral, intravaginal, transdermal); partner’s use of progestogen-only hormonal
- •contraception (oral, injectable/implantable, intrauterine hormone-releasing system);
- •partner’s use of implantable intrauterine device; surgical sterilisation (for example,
- •vasectomy or bilateral tubal occlusion).
- •14. Previous participation in any other drug investigational study within the past 30 days (or
- •five half-lives of investigational medicinal product [IMP] whichever is longer) prior to
- •15. Vulnerable patients according to Section 1.61 of the ICH guideline for Good Clinical
- •Practice E6.
研究者
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