Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease

Polycystic Liver Disease Clinical Trial

— LOCKCYST  

Official title:

An Open-label, Phase II Clinical Study to Evaluate the Efficacy and Safety of Lanreotide Autogel 90mg Every 4 Weeks in the Treatment of Symptomatic Polycystic Liver Disease, Including a Dose Escalation at Month 6 to Lanreotide Autogel 120mg for Non Responders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01315795
• Other study ID #: 2010-024604-10
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 11, 2011
• Last updated: July 7, 2014
• Start date: March 2011
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical Trial Summary

An open-label, Phase II clinical study to evaluate the efficacy and safety of lanreotide autogel 90mg every 4 weeks in the treatment of symptomatic polycystic liver disease, including a dose escalation at month 6 to lanreotide autogel 120mg for non responders.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Liver volume = 4 liter

• = 20 liver cysts

• Symptomatic patients defined as at least 2 out of 5 of the following symptoms related to mass effect irrespective of the intensity:

• Abdominal distention perceived as uncomfortable

• Frequent abdominal pain

• Early satiety

• Nausea (with the inclusion of dyspeptic complaints)

• Dyspnea

• Diagnosed with ADPKD or ADPLD

• Male and female patients of 18 years and older

• Written informed consent

Exclusion Criteria:

• Creatinine clearance < 20 ml/min

• Patient who underwent a kidney transplant and received variable doses of immunosuppressive therapy and/or present signs of rejection in the past year

• Hormonal replacement therapy

• Hormonal contraception

• Pregnant or lactating

• Presenting with an uncontrolled disease (other than ADPKD/ADPLD)

• Planned to undergo any surgery of the liver during study participation

• Planned to undergo any surgery of the KIDNEY during study participation (ADPKD patients only)

• Patients with known allergies to somatostatin or its analogues or any of its components

• Patients who received somatostatin analogues in the 6 months preceding study inclusion

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cysts
• Liver Diseases
• Polycystic Liver Disease

Intervention

Drug:
• Lanreotide Autogel 90 mg and 120 mg
administration of lanreotide sc every 4 weeks (28 days)

Locations

Country	Name	City	State
Belgium	UZ Leuven, Gasthuisberg	Leuven	Provincie Vlaams-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Ipsen

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

van Keimpema L, Nevens F, Vanslembrouck R, van Oijen MG, Hoffmann AL, Dekker HM, de Man RA, Drenth JP. Lanreotide reduces the volume of polycystic liver: a randomized, double-blind, placebo-controlled trial. Gastroenterology. 2009 Nov;137(5):1661-8.e1-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of total liver volume after 6 months of treatment measured by means of CT-scan.	Reduction of total liver volume after 6 months measured by means of CT-scan.	6 months	No
Primary	Reduction of total liver volume after 12 months of treatment by means of CT-scan	Reduction of total liver volume after 12 months of treatment by means of CT-scan	12 months	No
Primary	Reduction of total liver volume after 18 months of treatment by means of CT-scan	Reduction of total liver volume after 18 months of treatment by means of CT-scan	18 months	No
Secondary	Measurement of total liver and kidney volumes and cyst volumes at baseline.	Reduction of total liver volume Reduction of liver cyst volume Additonal reduction of total liver volume in the non responder group. Additonal reduction of liver cyst volume in the non responder group.; % of patients with liver reduction > 100 ml in the non responder group. Reduction of total kidney volume (ADPKD patients only) after 6 months, 1 year and 18 months	Baseline	No
Secondary	Measurement of total liver and kidney volumes and cyst volumes after 6 months of treatment by means of CT scan	Reduction of total liver volume Reduction of liver cyst volume Additonal reduction of total liver volume in the non responder group. Additonal reduction of liver cyst volume in the non responder group.; % of patients with liver reduction > 100 ml in the non responder group. Reduction of total kidney volume (ADPKD patients only) after 6 months, 1 year and 18 months	6 months	No
Secondary	Measurement of total liver and kidney volume and cyst volume after 12 months of treatment by means of CT scan.	Reduction of total liver volume Reduction of liver cyst volume Additonal reduction of total liver volume in the non responder group. Additonal reduction of liver cyst volume in the non responder group.; % of patients with liver reduction > 100 ml in the non responder group. Reduction of total kidney volume (ADPKD patients only) after 6 months, 1 year and 18 months	12 months	No
Secondary	Measurement of total liver and kidney volumes and cyst volumes after 18 months of treatment by means of CT scan	Reduction of total liver volume Reduction of liver cyst volume Additonal reduction of total liver volume in the non responder group. Additonal reduction of liver cyst volume in the non responder group.; % of patients with liver reduction > 100 ml in the non responder group. Reduction of total kidney volume (ADPKD patients only) after 6 months, 1 year and 18 months	18 months	No
Secondary	Assessment of quality of life at baseline	Assessment of quality of life at baseline	baseline	No
Secondary	Assessment of quality of life after 6 months of treatment	Assessment of quality of life after 6 months of treatment	6 months	No
Secondary	Assessment of quality of life after 12 months of treatment	Assessment of quality of life after 12 months of treatment	12 months	No
Secondary	Assessment of quality of life after 18 months of treatment	Assessment of quality of life after 18 months of treatment	18 months	No

External Links

•   Lanreotide reduces the volume of polycystic liver: a randomized, double-blind, placebo-controlled trial.