EUCTR2018-003093-27-GB进行中（未招募）1 期
A Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB002 in Subjects with WHO Group 1 Pulmonary Arterial Hypertension (PAH) - GB002 in Adult Subjects with PAH
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- GB002, Inc.
- 入组人数
- 16
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 Evidence of a personally signed and dated informed consent document indicating the subject has been informed of all pertinent aspects of the study prior to initiation of any subject-mandated procedures. Willingness & ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- •2 Adult (males & females) aged 18-75 years (incl) with WHO Gp 1 PAH
- •3 A current diagnosis of symptomatic PAH classified by one of the following:
- •a Idiopathic or heritable PAH
- •b PAH associated with one of the following connective tissue diseases:
- •i Systemic sclerosis
- •ii Rheumatoid arthritis
- •iii Mixed CTD or overlap syndrome
- •iv Systemic lupus erythematosus
- •c PAH associated with anorexigen or methamphetamine use
- •4 A WHO/NYHA functional class II–IV symptomatology
- •5 Documentation of right heart catheterization prior to screening consistent with the diagnosis of PAH and meeting all following criteria:
- •a Mean pulmonary arterial pressure (mPAP) =25 mmHg (at rest)
- •b Pulmonary capillary wedge pressure (PCWP) =15 mmHg, or mean left atrial pressure (mLAP) or left ventricular-end diastolic pressure (LVEDP) =15 mmHg in the absence of left atrial obstruction
- •c Pulmonary vascular resistance (PVR) =4 mmHg/L/min or 320 dyn×sec/cm5
- •A qualifying cardiac catheterization is required during screening period if results of previous assessments are not documented
- •6 Treatment with single or combination therapy from classes of phosphodiesterase type 5 (PDE-V) inhibitors, guanylate cyclase (GC) stimulators, endothelin receptor antagonists, and prostanoids including prostacyclins and small molecule prostacyclin receptor agonists, eg, selexipag (with exception of inhaled prostanoids) is allowed. For this study, single or combination therapy with one or more of these drugs is considered PAH background therapy. Subjects who are intolerant of all PAH background therapy may be allowed to be randomized on a case-by-case basis in consultation with the Medical Monitor. PAH background medications should remain stable and unchanged for the past 30 days prior to screening. In addition, diuretic doses should be stable for the past 30 days prior to Screening. Diuretics (as needed) for intermittent weight gain (if prescribed 30 or more days prior to screening and unchanged within 30 days prior to Screening) will be considered a stable dose for this study.
- •7 Pulmonary function tests (PFTs) and diffusing capacity of the lungs for carbon monoxide (DLCO) at screening with the following criteria met:
- •a Forced expiratory volume in 1 second (FEV1) =70% (predicted)
- •b FEV1/forced vital capacity ratio (FEV1/FVC) >70%
- •c DLCO =40% predicted except for subject with PAH associated with systemic sclerosis (SSc-APAH) where DLCO =30% is required
- •If the subject uses continuous oxygen therapy, they must be able to complete PFTs without oxygen. Subjects who are unable to complete PFTs without oxygen therapy are not eligible for study
- •8 Body weight >40 kg at screening
- •9 6 Minute Walk Test (6MWT) distance >100 m at screening; if distance walked is not >100
排除标准
- •1 Participation in a device or other interventional clinical study within 1 month (30 days; or within 5 half-lives of the medication, whichever is longer) of Day 1
- •2 Clinically significant systemic hypertension or hypotension
- •3 History of left-sided heart disease and/or clinically significant cardiac disease, including but not limited to any of the following:
- •a Aortic or mitral valve disease (stenosis or regurgitation) defined as greater than mild aortic insufficiency, mild aortic stenosis (AS), mild mitral stenosis (MS), moderate mitral regurgitation (MR)
- •b.Mechanical or bioprosthetic cardiac valve
- •c Pericardial constriction or pericardial effusion with tamponade physiology
- •d Restrictive or congestive cardiomyopathy
- •e Left ventricular ejection fraction (LVEF) =50% ECHO performed within 84 days prior to Screening will be accepted with availability of results documentation. If ECHO results within 84 days prior to Sceening are not available, then ECHO will be performed as part of Sceening
- •f Symptomatic coronary disease
- •g Significant (2+ for regurgitation) valvular disease other than tricuspid or pulmonary regurgitation
- •h Acutely decompensated left heart failure within 1 month (30 days) of screening
- •i History of untreated obstructive sleep apnea
- •4 History of Atrial Septostomy
- •5 History of decompensated right heart failure within 30 days of screening (e.g., hospitalization for PAH or the need to add an additional PAH medication)
- •6 Use of inhaled prostanoids
- •7 Moderate to severe hepatic impairment classified as a Child-Pugh Class B or C at screening
- •8 An estimated glomerular filtration rate (eGFR) < 45 mL/min via CKD-epi at Screening or requires chronic renal replacement therapy for any cause
- •9 Requirement of intravenous (IV) inotropes (eg levosimendan, dopamine, dobutamine, milrinone; norepinephrine) other than a prostanoid within 1 month (30 days) of screening
- •10 A positive result for hepatitis B or C infection indicating prior infection (excluding hepatitis B antibody due to prior vaccination), human immunodeficiency virus (HIV) antibody, or tuberculosis (TB)
- •11 Pulmonary venous occlusive disease
- •12 Anemia: Hgb concentration <8.5 g/dL at Screening
- •13 Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or IP administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study; including but not necessarily limited to the following: malignancy within 5 years of Screening, with the exception of effectively treated or excised localized non-metastatic basal cell carcinoma of the skin and in situ carcinoma of the cervix; psychiatric disorder that compromises ability to give informed consent, substance abuse; history of stroke, transient ischemic attack (TIA), or intracranial hemorrhage; thyroid disease requiring treatment, gastrointestinal (GI) bleed requiring blood transfusion, history of pulmonary embolus or deep vein thrombosis (DVT), history of vasovagal syncope w
研究者
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