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

Primary Purpose

Polycystic Liver Disease

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Lanreotide Autogel 90 mg and 120 mg
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Liver Disease focused on measuring polycystic liver disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UZ Leuven, Gasthuisberg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Symptomatic polycystic liver disease (PCLD) patients

Arm Description

Symptomatic polycystic liver disease (PCLD) patients

Outcomes

Primary Outcome Measures

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.
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
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

Secondary Outcome Measures

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
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
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
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
Assessment of quality of life at baseline
Assessment of quality of life at baseline
Assessment of quality of life after 6 months of treatment
Assessment of quality of life after 6 months of treatment
Assessment of quality of life after 12 months of treatment
Assessment of quality of life after 12 months of treatment
Assessment of quality of life after 18 months of treatment
Assessment of quality of life after 18 months of treatment

Full Information

First Posted
January 11, 2011
Last Updated
July 7, 2014
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT01315795
Brief Title
Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Ipsen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Liver Disease
Keywords
polycystic liver disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Symptomatic polycystic liver disease (PCLD) patients
Arm Type
Experimental
Arm Description
Symptomatic polycystic liver disease (PCLD) patients
Intervention Type
Drug
Intervention Name(s)
Lanreotide Autogel 90 mg and 120 mg
Intervention Description
administration of lanreotide sc every 4 weeks (28 days)
Primary Outcome Measure Information:
Title
Reduction of total liver volume after 6 months of treatment measured by means of CT-scan.
Description
Reduction of total liver volume after 6 months measured by means of CT-scan.
Time Frame
6 months
Title
Reduction of total liver volume after 12 months of treatment by means of CT-scan
Description
Reduction of total liver volume after 12 months of treatment by means of CT-scan
Time Frame
12 months
Title
Reduction of total liver volume after 18 months of treatment by means of CT-scan
Description
Reduction of total liver volume after 18 months of treatment by means of CT-scan
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Measurement of total liver and kidney volumes and cyst volumes at baseline.
Description
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
Time Frame
Baseline
Title
Measurement of total liver and kidney volumes and cyst volumes after 6 months of treatment by means of CT scan
Description
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
Time Frame
6 months
Title
Measurement of total liver and kidney volume and cyst volume after 12 months of treatment by means of CT scan.
Description
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
Time Frame
12 months
Title
Measurement of total liver and kidney volumes and cyst volumes after 18 months of treatment by means of CT scan
Description
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
Time Frame
18 months
Title
Assessment of quality of life at baseline
Description
Assessment of quality of life at baseline
Time Frame
baseline
Title
Assessment of quality of life after 6 months of treatment
Description
Assessment of quality of life after 6 months of treatment
Time Frame
6 months
Title
Assessment of quality of life after 12 months of treatment
Description
Assessment of quality of life after 12 months of treatment
Time Frame
12 months
Title
Assessment of quality of life after 18 months of treatment
Description
Assessment of quality of life after 18 months of treatment
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederik Nevens, MD, PhD
Organizational Affiliation
UZ Leuven, Gasthuisberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven, Gasthuisberg
City
Leuven
State/Province
Provincie Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
19646443
Citation
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. doi: 10.1053/j.gastro.2009.07.052. Epub 2009 Jul 29.
Results Reference
result
PubMed Identifier
26073493
Citation
Temmerman F, Ho TA, Vanslembrouck R, Coudyzer W, Billen J, Dobbels F, van Pelt J, Bammens B, Pirson Y, Nevens F. Lanreotide Reduces Liver Volume, But Might Not Improve Muscle Wasting or Weight Loss, in Patients With Symptomatic Polycystic Liver Disease. Clin Gastroenterol Hepatol. 2015 Dec;13(13):2353-9.e1. doi: 10.1016/j.cgh.2015.05.039. Epub 2015 Jun 12.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/19646443
Description
Lanreotide reduces the volume of polycystic liver: a randomized, double-blind, placebo-controlled trial.

Learn more about this trial

Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease

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