Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease (LOCKCYST)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Ipsen

Information provided by:

Universitaire Ziekenhuizen Leuven

ClinicalTrials.gov Identifier:

NCT01315795

First received: January 11, 2011

Last updated: March 21, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 11, 2011

Last Updated Date

March 21, 2011

Start Date ^ICMJE

March 2011

Estimated Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01315795 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Polycystic Liver Disease

Intervention ^ICMJE

Drug: Lanreotide Autogel 90 mg and 120 mg

administration of lanreotide sc every 4 weeks (28 days)

Study Arm (s)

Experimental: Symptomatic polycystic liver disease (PCLD) patients

Symptomatic polycystic liver disease (PCLD) patients

Intervention: Drug: Lanreotide Autogel 90 mg and 120 mg

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2013

Estimated Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT01315795

Other Study ID Numbers ^ICMJE

2010-024604-10

Has Data Monitoring Committee

Responsible Party

Professor Frederik Nevens, UZ Leuven, Gasthuisberg

Study Sponsor ^ICMJE

Universitaire Ziekenhuizen Leuven

Collaborators ^ICMJE

Ipsen

Investigators ^ICMJE

Principal Investigator:

Frederik Nevens, MD, PhD

UZ Leuven, Gasthuisberg

Information Provided By

Universitaire Ziekenhuizen Leuven

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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