An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)

GB002, Inc.0 个研究点目标入组 80 人开始时间: 2021年4月13日最近更新: 2023年10月3日

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: 80

研究概览入排标准研究者记录与标识符相似试验

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

•Subjects must meet ALL the following inclusion criteria to be enrolled into the extension:
•Age and Sex
•1. Adult female subjects aged 18 to 80 years, inclusive, or adult male subjects aged 50 to 80 years, inclusive, at the time of signing the informed consent form (ICF).
•Type of Subject and Disease Characteristics
•2. Subjects must have completed a prior GB002 PAH study and, in the opinion of the Investigator and Sponsor, have been compliant with study procedures and have completed treatment with IP through parent study EOT visit.
•3. Treatment with standard of care PAH disease-specific background therapies (stable dose).
•Contraception
•Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
•4. Women of childbearing potential must have a negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) at extension enrolment visit before first administration of GB002 in this study. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required, and results must be negative.
•5. Women of nonchildbearing potential: Evidence of post-menopausal status. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
•- Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
•- Women = 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
•6. Women of childbearing potential who are not abstinent and intend to be sexually active with a non-sterilized male partner must be willing to use a highly effective method of contraception from consent through 30 days following the last administration of GB002; acceptable methods include hormonal contraception (oral contraceptives – as long as on stable dose, patch, implant, or injection), intrauterine devices or other form of highly effective contraception.
•Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable.
•Note: A vasectomized partner is acceptable.
•7. Male subjects: Non-sterilized male subjects who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom from consent through 90 days after the last dose of GB002. Male subjects should refrain from sperm donation throughout this period (except for male subjects participating in fertility analysis as part of this protocol).
•Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. Periodic abstinence, the rhythm method,

排除标准

•The subject must be excluded from participating in the study if he/she meets any of the following:
•Medical Conditions
•1. Persistent and clinically significant systemic hypertension or hypotension.
•2. Interval history of newly developed left-sided heart disease with onset or severity increased after participation in the parent or lead in-study, and/or clinically significant cardiac disease, unless reviewed and approved as eligible to participate in the study by Sponsor’s Medical Monitor (or designee), 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%.
•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 extension enrolment visit;
•i. History of severe and untreated obstructive sleep apnoea.
•3. Potentially life-threatening cardiac arrhythmia with an ongoing risk.
•4. Uncontrolled bacterial, viral, or fungal infections which require systemic therapy.
•5. Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or GB002 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 extension enrolment visit, 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, coagulopathy, history of stroke, transient ischemic attack (TIA) requiring concurrent oral coagulation therapy, or intracranial haemorrhage; history of pulmonary embolus or deep vein thrombosis (DVT), history of vasovagal syncope with phlebotomy.
•6. Currently pregnant or breastfeeding or intends to become pregnant during the duration of the study.
•7. History of portopulmonary hypertension or portal hypertension classified as Child-Pugh Class A or higher.
•8. Subjects with a history of severe milk protein allergy. In addition, subjects with known intolerance or hypersensitivity to lactose who, in the opinion of the investigator, may experience severe symptoms following the ingestion of lactose.
•9. Current use of inhaled tobacco and/or inhaled marijuana. Ingestible or topical marijuana is allowed, per local restrictions and regulations.
•10. Documented history of alcohol abuse and/or history of utilizing drugs of abuse (amphetamines, methamphetamines, cocaine, phencyclidine [PCP]).
•11. Have any other condition or reason that, in the opinion of the Investigator and/or the Sponsor’s Medical Monitor (or designee), would prohibit the subject from participating in the study.
•Diagnostic Assessments
•The most recent laboratory assessment from the parent study may be used to evaluate laboratory-associated exclusion criterion, if performed within 6 weeks (±

研究者

发起方

GB002, Inc.

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