NCT01315795

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

3.3 years

First QC Date

January 11, 2011

Last Update Submit

July 7, 2014

Conditions

Polycystic Liver Disease

Keywords

polycystic liver disease

Outcome Measures

Primary Outcomes (3)

  • 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.

    6 months

  • 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

    12 months

  • 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

    18 months

Secondary Outcomes (8)

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

    Baseline

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

    6 months

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

    12 months

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

    18 months

  • Assessment of quality of life at baseline

    baseline

  • +3 more secondary outcomes

Study Arms (1)

Symptomatic polycystic liver disease (PCLD) patients

EXPERIMENTAL

Symptomatic polycystic liver disease (PCLD) patients

Drug: Lanreotide Autogel 90 mg and 120 mg

Interventions

Lanreotide Autogel 90 mg and 120 mgDRUG

administration of lanreotide sc every 4 weeks (28 days)

Symptomatic polycystic liver disease (PCLD) patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Dyspnea
  • Diagnosed with ADPKD or ADPLD
  • Male and female patients of 18 years and older
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven, Gasthuisberg

Leuven, Provincie Vlaams-Brabant, 3000, Belgium

Location

Related Publications (2)

  • 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.

    PMID: 19646443RESULT

  • 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.

    PMID: 26073493DERIVED

Related Links

MeSH Terms

Conditions

Polycystic liver disease

Study Officials

  • Frederik Nevens, MD, PhD

    UZ Leuven, Gasthuisberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr Frederik Nevens

Study Record Dates

First Submitted

January 11, 2011

First Posted

March 15, 2011

Study Start

March 1, 2011

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

July 8, 2014

Record last verified: 2014-07

Locations

BE(1)