idiopathic pleuroparenchymal fibroelastosis
Conditions
Interventions
Administration of 100 mg of anamorelin once daily for 8 weeks to patients with idiopathic pleuroparenchymal fibroelastosis
Sponsors
Yasui Hideki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of anorexia and cachexia | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactHideki Yasui
Hamamatsu University Hospital
Outcome results
None listed