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Open-Label Extension of LOCKCYST Trial (LOCKCYST-ext)

Primary Purpose

Polycystic Liver Disease, Hepatomegaly, Liver Diseases

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
lanreotide
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Liver Disease

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participated in the LOCKCYST trial
  • 18 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University Hospital Gasthuisberg, University of Leuven
  • Radboud University Nijmegen Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

lanreotide

Outcomes

Primary Outcome Measures

Liver volume reduction

Secondary Outcome Measures

Kidney volume Cyst volume

Full Information

First Posted
October 13, 2008
Last Updated
November 12, 2008
Sponsor
Radboud University Medical Center
Collaborators
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT00771888
Brief Title
Open-Label Extension of LOCKCYST Trial
Acronym
LOCKCYST-ext
Official Title
Open-Label Extension of the LOCKCYST Trial, LOCKCYST: Long Acting Lnareotide as as Volume Reducing Treatment of Polycystic Livers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
August 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center
Collaborators
Ipsen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
van Keimpema L, de Man RA, Drenth JP. Somatostatin analogues reduce liver volume in polycystic liver disease. Gut 2008 September;57(9):1338-9.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Liver Disease, Hepatomegaly, Liver Diseases, Polycystic Kidney, Autosomal Dominant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
lanreotide
Intervention Type
Drug
Intervention Name(s)
lanreotide
Intervention Description
lanreotide
Primary Outcome Measure Information:
Title
Liver volume reduction
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Kidney volume Cyst volume
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participated in the LOCKCYST trial 18 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joost PH Drenth, PhD
Organizational Affiliation
Radboud University Nijmegen Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frederik Nevens, MD, PhD
Organizational Affiliation
University Hospital Gasthuisberg, University of Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Loes van Keimpema, MSc
Organizational Affiliation
Radboud University Nijmegen Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Gasthuisberg, University of Leuven
City
Leuven
Country
Belgium
Facility Name
Radboud University Nijmegen Medical Center
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
18719151
Citation
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.
Results Reference
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Open-Label Extension of LOCKCYST Trial

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