anreotide Autogel for the treatment of patients with Idiopathic Pulmonary Fibrosis (IPF)

• Conditions: Idiopathic Pulmonary Fibrosis; MedDRA version: 14.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-003687-78-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-05
• Last Update Posted: 24 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) 2. Age > 30, <75 3. Life expenctancy of more than 1 year 4. DLCO%>40% 5. expression of somatostatin receptors assessed by 68Ga-DOTA-NOC PET/CT 6. Adeguate bone marrow function, normal hepatic and kidney function, assessed by tests performed within the 14 days before starting treatment: leukocytes>3.000/µl, neutrophils (ANC) >1.500/µl, paltelets>100.000/µl, bilirubin <1.5 times the normal upper (ULN), AST(SGOT) and ALT(SGPT) <2.5xULN, creatinin <1.25xULN (or >1.25xULN and <1.5xULN con creatinin clearance>60ml/min). 7. Signed Informed Consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Pregnancy 2. Breast feeding 3. Healthy volunteers 4. Age <30, >75 years 5. Other forms of Interstitial lung disorders 6. Patients in emergency state 7. Individuals with reduced approval competence expressing any reluctance to participate to the study as well as those not understanding the purpose of the study 8. Severe cardiovascular conditions: stroke (?6 mesi), AMI (?6 mesi), astable angina, heart congestive failure NYHAII or higher, serious arythmias requiring treatment 9. Concomitant inflammatory disorders 10. Severe Parkinson disease 11. Colelithiasis 12. Informed consent not signed 13. Concomitant or recent neoplastic

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified