The usefulness of anamorelin for iPPFE

JRCT ID: jRCTs041220165

Registered date:30/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: idiopathic pleuroparenchymal fibroelastosis
• Date of first enrollment: 02/06/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Administration of 100 mg of anamorelin once daily for 8 weeks to patients with idiopathic pleuroparenchymal fibroelastosis

Outcome(s)

• Primary Outcome: Assessment of anorexia and cachexia

Secondary Outcome

Assessment of anorexia and cachexia
Adverse events (safety)
Changes in body weight from the initiation of the intervention
Area and CT value of erector spinae muscle at Th12 level on chest CT
Lean body mass using DXA (dual-energy X-ray absorptiometry) method
Evaluation of gastrointestinal symptoms
Respiratory-related quality of life, and evaluation of dyspnea
Nutritional status on blood tests

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients over 20 years old
Patients diagnosed with iPPFE based on CT imaging and clinical findings
Patients whose consent for this study has been obtained by signing a consent form

Exclude criteria

Patients with a history of hypersensitivity to anamorelin
Patients with congestive heart failure
Patients with myocardial infarction or angina pectoris
Patients with severe conduction defects (e.g., complete atrioventricular block)
Patients who have received or are currently taking the following drugs within 1 week prior to the start of study treatment: clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, telaprevir, voriconazole, ritonavir-containing products, cobicistat-containing products
Patients with hepatic dysfunction of moderate severity or greater (Child-Pugh classification B and C)
Patients with difficulty in oral intake of food due to obstruction of the gastrointestinal tract or other organic abnormality of the gastrointestinal tract
Patients with diabetes mellitus who have poor glycemic control despite the use of oral diabetes medications or insulin
Pregnant or nursing mothers
Patients who are deemed inappropriate by the principal investigator (or sub-investigator)

Related Information

• Primary Sponsor: Yasui Hideki
• Source(s) of Monetary Support: Japan Research Foundation for Clinical Pharmacology