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Completed

NCT Number: NCT01315795

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.

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Key information

Conditions

Polycystic Liver Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

UZ Leuven, Gasthuisberg

Leuven, Provincie Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lanreotide Autogel 90 mg and 120 mg

Drug

administration of lanreotide sc every 4 weeks (28 days)

Primary outcomes

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

    Time frame: 6 months

    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

    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

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

Secondary outcomes

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

    Time frame: 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

  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

    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

    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

    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

    Assessment of quality of life at baseline

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

    Time frame: 6 months

    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

    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

    Assessment of quality of life after 18 months of treatment

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Ipsen

Registry information

Official study 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

Acronym: LOCKCYST

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 15, 2011
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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