Prospective, open-label, interventional study to explore the efficacy of the ghrelin agonist anamorelin in patients with cachexia associated with chronic obstructive pulmonary disease

Ikari Jun0 个研究点目标入组 28 人开始时间: 2023年11月13日最近更新: 2024年1月22日

适应症

试验速览

暂无简介。

•1) Adults 18years of age or older at the time of consent
•2) Patients diagnosed with COPD
•3) Patients with non-arbitrary wight loss of 2% or more within 3-6 months, or BMI<21kg/m2
•4) Patients who meet one or more criterias of following three
•a. Anorexia
•b. Decreased grip strength (<28kg in men and <18kg in women)
•c. CRP > 0.5mg/dL
•5) Patients receiving appropriate pharmacological therapy for COPD
•6) Patients who have been informed of the study and who have given written consent of their own free will

•1) Patients who have been introduced to new inhalation or nutritional therapy during the period from 4 weeks prior to the start of the study to the start of the study
•2) Poorly controlled diabetes mellitus
•3) Patients with the following contraindications to anamorelin administration
•a. Patients with a history of hypersensitivity to anamorelin
•b. Patients with congestive heart failure
•c. Patients with myocardial infarction or angina pectoris
•d. Patients with severe conduction defects (e.g., complete atrioventricular block)
•e. Patients receiving the following drugs (clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, telaprevir, voriconazole, ritonavir-containing products, cobicistat-containing products)
•f. Hepatic dysfunction of moderate severity or greater (Child-Pugh Classification B or C)
•g. Patients with difficulty in oral intake of food due to gastrointestinal obstruction or other organic abnormalities of the gastrointestinal tract.
•4) Patients who are pregnant, possibly pregnant, within 28 days postpartum, or lactating.
•5) Other patients whom the investigator determines to be unsuitable for the safe conduct of this study.

发起方

Ikari Jun