EUCTR2018-002796-18-ES进行中（未招募）1 期
An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease
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
入选标准
- •1. Have completed MPV3 of the preceding study BIA-51058-201.
- •2. Able to comprehend and willing to sign an informed consent form
- •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. Significant non-compliance with the protocol during the preceding study BIA-51058-201 which may have an impact on this extension study.
- •2. WHO functional class IV as judged by the investigator.
- •3. Persistent hypotension defined as systolic blood pressure (SBP) < 95 mmHg or diastolic blood pressure (DBP) < 50 mmHg.
- •4. Uncontrolled diabetes mellitus.
- •5. Occurrence of an AE during the preceding study which is judged by the investigator as contraindicative to further participation in the extension study.
- •6. Any disease known to cause pulmonary hypertension other than PAH WHO Group 1, e.g. obstructive lung diseases, parasitic disease affecting the pulmonary system, sickle cell anaemia, left heart disease.
- •7. History of moderate to severe hepatic impairment (Child-Pugh B and C).
- •8. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (measured at V1).
- •9. 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.
- •10. 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.
- •11. For women: Pregnancy or breast-feeding. Women of childbearing potential unable or unwilling to undergo pregnancy tests and practice acceptable contraceptive measures. Acceptable methods for women are surgical intervention (e.g. bilateral tubal occlusion), intrauterine device, double-barrier methods and true sexual abstinence (i.e. when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- •12. Concurrent participation in any other drug investigational study, except BIA-51058-201.
- •13. Vulnerable patients according to Section 1.61 of the ICH guideline for Good Clinical Practice E6.
研究者
相似试验
进行中（未招募）
1 期
To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH.MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersPulmonary arterial hypertensionEUCTR2018-002796-18-PTBial - Portela & Ca, S.A.40
进行中（未招募）
1 期
To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH.Pulmonary arterial hypertensionEUCTR2018-002796-18-ITBIAL-Portela & Ca, S.A.40
进行中（未招募）
1 期
To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH.Pulmonary arterial hypertensionMedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2018-002796-18-ATBial - Portela & Ca, S.A.40
进行中（未招募）
1 期
To study the safety and how effective Long-term Zamicastat treatment is for Pulmonary Arterial HypertensioPulmonary Arterial HypertensionMedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2018-002796-18-GBBial - Portela & Ca, S.A32
进行中（未招募）
1 期
A Study to Evaluate the Safety of Long-term Treatment with Siltuximab in Patients with Multicentric Castleman's DiseaseMulticentric Castleman's DiseaseMedDRA version: 14.1 Level: PT Classification code 10050251 Term: Castleman's disease System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-022837-27-GBJanssen-Cilag International N.V.60