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

This study has been completed.
Sponsor:
Collaborator:
Ipsen
Information provided by (Responsible Party):
Dr Frederik Temmerman, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01315795
First received: January 11, 2011
Last updated: July 7, 2014
Last verified: July 2014

January 11, 2011
July 7, 2014
March 2011
July 2014   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01315795 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Polycystic Liver Disease
Drug: Lanreotide Autogel 90 mg and 120 mg
administration of lanreotide sc every 4 weeks (28 days)
Experimental: Symptomatic polycystic liver disease (PCLD) patients
Symptomatic polycystic liver disease (PCLD) patients
Intervention: Drug: Lanreotide Autogel 90 mg and 120 mg
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.
 
Completed
59
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01315795
2010-024604-10
No
Dr Frederik Temmerman, Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
Ipsen
Principal Investigator: Frederik Nevens, MD, PhD UZ Leuven, Gasthuisberg
Universitaire Ziekenhuizen Leuven
July 2014

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