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

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. Identifier: NCT00771888
Recruitment Status : Unknown
Verified November 2008 by Radboud University.
Recruitment status was:  Active, not recruiting
First Posted : October 15, 2008
Last Update Posted : November 13, 2008
Information provided by:
Radboud University

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: N/A
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
Study Start Date : April 2008
Actual Primary Completion Date : October 2008
Estimated Study Completion Date : August 2009

Arm Intervention/treatment
Drug: lanreotide

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Older Adult)
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

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 identifier (NCT number): NCT00771888

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University Hospital Gasthuisberg, University of Leuven
Leuven, Belgium
Radboud University Nijmegen Medical Center
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
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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
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Responsible Party: Radboud University Nijmegen Medical Center Identifier: NCT00771888    
Other Study ID Numbers: NL16194.091.07
First Posted: October 15, 2008    Key Record Dates
Last Update Posted: November 13, 2008
Last Verified: November 2008
Additional relevant MeSH terms:
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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