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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
  Purpose

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.


Condition Intervention Phase
Polycystic Liver Disease
Drug: Lanreotide Autogel 90 mg and 120 mg
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 59
Study Start Date: March 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Symptomatic polycystic liver disease (PCLD) patients
Symptomatic polycystic liver disease (PCLD) patients
Drug: Lanreotide Autogel 90 mg and 120 mg
administration of lanreotide sc every 4 weeks (28 days)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315795

Locations
Belgium
UZ Leuven, Gasthuisberg
Leuven, Provincie Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Ipsen
Investigators
Principal Investigator: Frederik Nevens, MD, PhD UZ Leuven, Gasthuisberg
  More Information

Additional Information:
Publications:
Responsible Party: Dr Frederik Temmerman, Professor Dr Frederik Nevens, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01315795     History of Changes
Other Study ID Numbers: 2010-024604-10
Study First Received: January 11, 2011
Last Updated: July 7, 2014
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by Universitaire Ziekenhuizen Leuven:
polycystic liver disease

Additional relevant MeSH terms:
Cysts
Liver Diseases
Digestive System Diseases
Neoplasms
Pathological Conditions, Anatomical
Angiopeptin
Lanreotide
Antineoplastic Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014