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

Lanreotide Autogel for the treatment of patients with Idiopathic Pulmonary Fibrosis (IPF) - IPF/LANREOTIDE/2011-01

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003687-78-IT

Enrollment

Registered

2012-03-05

Start date

2012-02-21

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis MedDRA version: 14.1 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Pharmaceutical Form: Solution for injection INN or Proposed INN: LANREOTIDE ACETATE CAS Number: 127984-74-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 120- Pr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) 2. Age > 30, 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 1.25xULN and 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

Exclusion criteria: 1. Pregnancy 2. Breast feeding 3. Healthy volunteers 4. Age 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the use of Lanreotide Autogel for the treatment of patients with IPF. In particular, primary aim of the study is to assess whether Lanretoitde Autogel therapy is able to improve or stabilize pulmonary function parameters (DLCO and FVC), considered as markers of disease state in international guidelines. Disease progression is defined by a reduction of >15% of DLCO with or without associated reduction of >10% FVC as compared to baseline values. Data will also be compared to a historical group of IPF patients treatment with standard regimen;Secondary Objective: 1) evaluate Lanreotide Autogel in improving overall survival in patients with IPF 2) assess the capacity of Lanreotide Autogel in reducing the number of disease reacutizations in patients with IPF (reported incidence of reacutization estimated by the American Thoracic Society is approximately 5-10% ) 3) evaluate whether 68Ga-DOTA-NOC PET/CT SUVmax could be employed as a valuable non invasive parameter to select patients with higher somatostatin receptors expression that are more likely to respond to Lanreotide Autogel treatment. 4) assess Lanreotide Autogel efficacy in stabilizing disease extension on HRTC 5) assess Lanreotide Autogel toxicity in patients with IPF.;Primary end point(s): To assess Lanreotide Autogel use in promoting improvement or stabilization of DLCO and FVC, markers of disease progression according to the American Thoracic Society guidelines. Disease progression is defined by a reduction of >15% of DLCO with or without associated reduction of >10% FVC as compared to baseline values.;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: To evaluate the use of Lanreotide Autogel for the treatment of patients with IPF. In particular, primary aim of the study is to assess whether Lanretoitde Autogel therapy is able to improve or stabilize pulmonary function parameters (DLCO and FVC), considered as markers of disease state in international guidelines. Disease progression is defined by a reduction of >15% of DLCO with or without associated reduction of >10% FVC as compared to baseline values. Data will also be compared to a historical group of IPF patients treatment with standard regimen;Secondary Objective: 1) evaluate Lanreotide Autogel in improving overall survival in patients with IPF 2) assess the capacity of Lanreotide Autogel in reducing the number of disease reacutizations in patients with IPF (reported incidence of reacutization estimated by the American Thoracic Society is approximately 5-10% ) 3) evaluate whether 68Ga-DOTA-NOC PET/CT SUVmax could be employed as a valuable non invasive parameter to select patients with higher somatostatin receptors expression that are more likely to respond to Lanreotide Autogel treatment. 4) assess Lanreotide Autogel efficacy in stabilizing disease extension on HRTC 5) assess Lanreotide Autogel toxicity in patients with IPF.;Primary end point(s): To assess Lanreotide Autogel use in promoting improvement or stabilization of DLCO and FVC, markers of disease progression according to the American Thoracic Society guidelines. Disease progression is defined by a reduction of >15% of DLCO with or without associated reduction of >10% FVC as compared to baseline values.;Timepoint(s) of evaluation of this end point: 12 months

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Secondary

Measure	Time frame
Secondary end point(s): 1) evaluate Lanreotide Autogel in improving overall survival in patients with IPF 2) assess the capacity of Lanreotide Autogel in reducing the number of disease reacutizations in patients with IPF (reported incidence of reacutization estimated by the American Thoracic Society is approximately 5-10% ) 3) evaluate whether 68Ga-DOTA-NOC PET/CT SUVmax could be employed as a valuable non invasive parameter to select patients with higher somatostatin receptors expression that are more likely to respond to Lanreotide Autogel treatment. 4) assess Lanreotide Autogel efficacy in stabilizing disease extension on HRTC 5) assess Lanreotide Autogel toxicity in patients with IPF.;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Secondary end point(s): 1) evaluate Lanreotide Autogel in improving overall survival in patients with IPF 2) assess the capacity of Lanreotide Autogel in reducing the number of disease reacutizations in patients with IPF (reported incidence of reacutization estimated by the American Thoracic Society is approximately 5-10% ) 3) evaluate whether 68Ga-DOTA-NOC PET/CT SUVmax could be employed as a valuable non invasive parameter to select patients with higher somatostatin receptors expression that are more likely to respond to Lanreotide Autogel treatment. 4) assess Lanreotide Autogel efficacy in stabilizing disease extension on HRTC 5) assess Lanreotide Autogel toxicity in patients with IPF.;Timepoint(s) of evaluation of this end point: 12 months

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Countries

Italy

Contacts

Public ContactU.O. Medicina Interna-Tomassetti

AOU di Bologna

paola.tomassetti@unibo.it051/6364186

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026