NCT00771888

Brief Summary

Positive data originating from two polycystic liver patients treated with somatostatin analogues, showed a volume reduction of 38.3% and 14.9%. These two patients had complicated polycystic livers and no other therapeutic options were available. Patients who participated in LOCKCYST trial are able to benefit from active treatment. Participants will be actively treated for 24 weeks.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_2

Geographic Reach
2 countries

2 active sites

Status
unknown

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

Study Start

First participant enrolled

April 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 15, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

November 13, 2008

Status Verified

November 1, 2008

Enrollment Period

6 months

First QC Date

October 13, 2008

Last Update Submit

November 12, 2008

Conditions

Polycystic Liver DiseaseHepatomegalyLiver DiseasesPolycystic KidneyAutosomal Dominant

Outcome Measures

Primary Outcomes (1)

  • Liver volume reduction

    24 weeks

Secondary Outcomes (1)

  • Kidney volume Cyst volume

    24 weeks

Study Arms (1)

1

OTHER

lanreotide

Drug: lanreotide

Interventions

lanreotideDRUG

lanreotide

1

Eligibility Criteria

Age18 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participated in the LOCKCYST trial
  • yrs-of age
  • Multiple cysts \> 20
  • Cooperating patient
  • Is willing and able to comply with the study drug regimen and all other study requirements.
  • Willingness to give written informed consent

You may not qualify if:

  • Use of oral anticonceptives or estrogen suppletion
  • Females who are pregnant or breast-feeding
  • History or other evidence of chronic pulmonary disease associated with functional limitation
  • History of severe cardiac disease (eg, NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases). In addition, patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled.
  • History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
  • Symptomatic gallstones (lanreotide decreases gall bladder volume)
  • Renal failure requiring hemodialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Gasthuisberg, University of Leuven

Leuven, Belgium

Location

Radboud University Nijmegen Medical Center

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (1)

  • van Keimpema L, de Man RA, Drenth JP. Somatostatin analogues reduce liver volume in polycystic liver disease. Gut. 2008 Sep;57(9):1338-9. doi: 10.1136/gut.2008.155721. No abstract available.

    PMID: 18719151BACKGROUND

MeSH Terms

Conditions

Polycystic liver diseaseHepatomegalyLiver DiseasesPolycystic Kidney DiseasesMultiple Pterygium Syndrome, Autosomal Dominant

Interventions

lanreotide

Condition Hierarchy (Ancestors)

Digestive System DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsKidney Diseases, CysticKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCiliopathiesGenetic Diseases, Inborn

Study Officials

  • Joost PH Drenth, PhD

    Radboud University Nijmegen Medical Center

    PRINCIPAL INVESTIGATOR

  • Frederik Nevens, MD, PhD

    University Hospital Gasthuisberg, University of Leuven

    PRINCIPAL INVESTIGATOR

  • Loes van Keimpema, MSc

    Radboud University Nijmegen Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 13, 2008

First Posted

October 15, 2008

Study Start

April 1, 2008

Primary Completion

October 1, 2008

Study Completion

August 1, 2009

Last Updated

November 13, 2008

Record last verified: 2008-11

Locations

NL(1)BE(1)