Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease - Full Text View

Sponsor:	Universitaire Ziekenhuizen Leuven
Collaborator:	Ipsen
Information provided by:	Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:	NCT01315795

Purpose

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.

Condition	Intervention	Phase
Polycystic Liver Disease	Drug: Lanreotide Autogel 90 mg and 120 mg	Phase 2 Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Liver Diseases Nuclear Scans

Drug Information available for: Lanreotide Lanreotide acetate

U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:

Reduction of total liver volume after 6 months of treatment measured by means of CT-scan. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Reduction of total liver volume after 6 months measured by means of CT-scan.
Reduction of total liver volume after 12 months of treatment by means of CT-scan [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Reduction of total liver volume after 12 months of treatment by means of CT-scan
Reduction of total liver volume after 18 months of treatment by means of CT-scan [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Reduction of total liver volume after 18 months of treatment by means of CT-scan

Secondary Outcome Measures:

Measurement of total liver and kidney volumes and cyst volumes at baseline. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
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
Measurement of total liver and kidney volumes and cyst volumes after 6 months of treatment by means of CT scan [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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
Measurement of total liver and kidney volume and cyst volume after 12 months of treatment by means of CT scan. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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
Measurement of total liver and kidney volumes and cyst volumes after 18 months of treatment by means of CT scan [ Time Frame: 18 months ] [ Designated as safety issue: No ]
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
Assessment of quality of life at baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
Assessment of quality of life at baseline
Assessment of quality of life after 6 months of treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Assessment of quality of life after 6 months of treatment
Assessment of quality of life after 12 months of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Assessment of quality of life after 12 months of treatment
Assessment of quality of life after 18 months of treatment [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Assessment of quality of life after 18 months of treatment

Estimated Enrollment:	62
Study Start Date:	March 2011
Estimated Study Completion Date:	February 2013
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Symptomatic polycystic liver disease (PCLD) patients Symptomatic polycystic liver disease (PCLD) patients	Drug: Lanreotide Autogel 90 mg and 120 mg administration of lanreotide sc every 4 weeks (28 days)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315795

Contacts

Contact: Frederik Nevens, PhD, MD	+3216344299	frederik.nevens@uzleuven.be
Contact: Frederik Temmerman, MD	+3216344299	frederik.temmerman@uzleuven.be

Locations

Belgium
UZ Leuven, Gasthuisberg	Recruiting
Leuven, Provincie Vlaams-Brabant, Belgium, 3000
Contact: Frederik Nevens, PhD, MD +3216344299 frederik.nevens@uzleuven.be
Contact: Frederik Temmerman, MD +3216344299 frederik.temmerman@uzleuven.be
Principal Investigator: Frederik Nevens, PhD, MD

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Ipsen

Investigators

Principal Investigator:

Frederik Nevens, MD, PhD

UZ Leuven, Gasthuisberg

More Information

Additional Information:

Lanreotide reduces the volume of polycystic liver: a randomized, double-blind, placebo-controlled trial. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2009 Jul 29.

Responsible Party:	Professor Frederik Nevens, UZ Leuven, Gasthuisberg
ClinicalTrials.gov Identifier:	NCT01315795 History of Changes
Other Study ID Numbers:	2010-024604-10
Study First Received:	January 11, 2011
Last Updated:	March 21, 2011
Health Authority:	Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by Universitaire Ziekenhuizen Leuven:

polycystic liver disease

Additional relevant MeSH terms:

Liver Diseases
Cysts
Digestive System Diseases
Neoplasms
Pathological Conditions, Anatomical
Lanreotide

Angiopeptin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2012