CTIS2022-501462-22-00招募中1 期
A Phase 2 Study to Evaluate Efficacy, Safety, and Pharmacokinetics of PBF-999 in the Treatment of Patients with Prader-Willi Syndrome. - PBF-999CT-04
Palo Biofarma S.L.0 个研究点目标入组 30 人开始时间: 2022年8月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 64（—）
- 性别
- All
入选标准
- •Male and female outpatients between 12 and 65 years of age inclusive, before signing informed consent., Confirmed diagnosis of PWS based on genetic confirmation using DNA methylation test., Body mass index (BMI) up to 65 kg/m2, inclusive, at Visit 1. This criterion applies only for adult patients., No evidence of weight excursion beyond 10% of baseline weight within 3 months prior to Visit 1 (self- or caregiver-reported). This criterion applies only for adult patients., Patients must provide assent and have a reliable caregiver (must have been caring for the patient for at least 6 months) who provides a separate written informed consent to participate. In the case of paediatric population, parent’s consent shall be obtained too., Women of child-bearing potential (WCBP) must have a negative pregnancy test. All WCBP, sexually active male patients, and all opposite sex partners of patients should agree to use medically approved effective methods of birth control.
排除标准
- •Are currently enrolled in any other clinical trial involving a study drug., Patients on weight loss medications within 30 days of dosing (GLP1 agonists at doses for Diabetes treatment are allowed)., Regular user of known drugs of abuse., Any major surgery within 60 days prior to the first dose or has planned elective surgeries to occur during the study., Unsuitable for inclusion in the study in the opinion of the investigator., Participated in a clinical trial within 30 days (defined as last dose of study drug), prior to the PBF-999 first dose., Are currently living in a group home for more than 50% of the time, except when in the group home, there is a primary caregiver throughout the study in frequent contact with the patient (defined as at least 4 awake hours per day)., Have clinical laboratory test results outside normal reference range, or any clinically significant laboratory abnormality, that in the judgment of the investigator, indicates a medical problem that would preclude study participation., Are hypertensive (defined as sitting systolic BP =140 mmHg and diastolic BP =90 mmHg) on or off medications for the treatment of hypertension. Blood pressure may be re-tested up to 2 additional times, under well-rested conditions., In addition to conditions described below, have a history or presence of any other medical illness including but not limited to any autoimmune disorder, cardiovascular, hepatic, respiratory, hematological, or uncontrolled neurological disease., Have evidence of significant active or unstable/uncontrolled psychiatric disease by medical history, such as bipolar disorder, schizophrenia, personality disorders, or other serious mood or anxiety disorders., Have an abnormality in the 12-lead electrocardiogram (ECG) or an abnormality that, in the opinion of the investigator, increases the risks associated with participating in the study., Have a family history of Long QT Syndrome.
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