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Trial · Interventional

CompletedPhase 2/3Registry data

Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease

Short name LOCKCYST

NCTNCT01315795 (opens ClinicalTrials.gov in a new tab)Other id2010-024604-10
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2/3
Enrollment
59 participants (actual)
Sponsor
Universitaire Ziekenhuizen KU Leuven · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Belgium

Start
Mar 2011
Primary completion
Jul 2014
Completion
Jul 2014
First posted
15 Mar 2011 (estimated)
Last update posted
8 Jul 2014 (estimated)
Conditions
Polycystic Liver Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20112012201320142015
  1. Ph 2/3

    LOCKCYST

    NCT01315795

    Mar 2011 to Jul 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Lanreotide Autogel 90 mg and 120 mgDrug

Arms1

  • Experimental

    Symptomatic polycystic liver disease (PCLD) patients

    Symptomatic polycystic liver disease (PCLD) patients

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Reduction of total liver volume after 6 months of treatment measured by means of CT-scan.

    Time frame · 6 months

    Registry description

    Reduction of total liver volume after 6 months measured by means of CT-scan.

  2. Reduction of total liver volume after 12 months of treatment by means of CT-scan

    Time frame · 12 months

    Registry description

    Reduction of total liver volume after 12 months of treatment by means of CT-scan

  3. Reduction of total liver volume after 18 months of treatment by means of CT-scan

    Time frame · 18 months

    Registry description

    Reduction of total liver volume after 18 months of treatment by means of CT-scan

Secondary outcomes(8)

  1. Measurement of total liver and kidney volumes and cyst volumes at baseline.

    Time frame · Baseline

    Registry 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

  2. Measurement of total liver and kidney volumes and cyst volumes after 6 months of treatment by means of CT scan

    Time frame · 6 months

    Registry 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

  3. Measurement of total liver and kidney volume and cyst volume after 12 months of treatment by means of CT scan.

    Time frame · 12 months

    Registry 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

  4. Measurement of total liver and kidney volumes and cyst volumes after 18 months of treatment by means of CT scan

    Time frame · 18 months

    Registry 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

  5. Assessment of quality of life at baseline

    Time frame · baseline

    Registry description

    Assessment of quality of life at baseline

  6. Assessment of quality of life after 6 months of treatment

    Time frame · 6 months

    Registry description

    Assessment of quality of life after 6 months of treatment

  7. Assessment of quality of life after 12 months of treatment

    Time frame · 12 months

    Registry description

    Assessment of quality of life after 12 months of treatment

  8. Assessment of quality of life after 18 months of treatment

    Time frame · 18 months

    Registry description

    Assessment of quality of life after 18 months of treatment

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2009

4 results

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

van Keimpema et al. 2009Gastroenterologycited by 176

PMID 19646443DOI 10.1053/j.gastro.2009.07.052PUB-19646443

Full text at the publisher4 results
Publisher pageSee results (4)

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2015

Lanreotide Reduces Liver Volume, But Might Not Improve Muscle Wasting or Weight Loss, in Patients With Symptomatic Polycystic Liver Disease.

Temmerman et al. 2015Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Associationcited by 28

PMID 26073493DOI 10.1016/j.cgh.2015.05.039PUB-26073493

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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