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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by Radboud University.
Recruitment status was:  Active, not recruiting
ClinicalTrials.gov Identifier:
First Posted: October 15, 2008
Last Update Posted: November 13, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Radboud University

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.

Condition Intervention Phase
Polycystic Liver Disease Hepatomegaly Liver Diseases Polycystic Kidney Autosomal Dominant Drug: lanreotide Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Extension of the LOCKCYST Trial, LOCKCYST: Long Acting Lnareotide as as Volume Reducing Treatment of Polycystic Livers

Resource links provided by NLM:

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Liver volume reduction [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Kidney volume Cyst volume [ Time Frame: 24 weeks ]

Estimated Enrollment: 54
Study Start Date: April 2008
Estimated Study Completion Date: August 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Drug: lanreotide

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00771888

University Hospital Gasthuisberg, University of Leuven
Leuven, Belgium
Radboud University Nijmegen Medical Center
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Principal Investigator: 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
  More Information

Responsible Party: Radboud University Nijmegen Medical Center
ClinicalTrials.gov Identifier: NCT00771888     History of Changes
Other Study ID Numbers: NL16194.091.07
First Submitted: October 13, 2008
First Posted: October 15, 2008
Last Update Posted: November 13, 2008
Last Verified: November 2008

Additional relevant MeSH terms:
Liver Diseases
Polycystic Kidney Diseases
Digestive System Diseases
Kidney Diseases, Cystic
Kidney Diseases
Urologic Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Pathological Conditions, Anatomical
Antineoplastic Agents