Open-Label Extension of LOCKCYST Trial

Phase 2

• Conditions: Polycystic Liver Disease; Hepatomegaly; Liver Diseases; Polycystic Kidney; Autosomal Dominant
• Interventions: Drug: lanreotide

• Registration Number: NCT00771888
• Lead Sponsor: Radboud University Medical Center

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.

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2008-10
• Study First Submitted: 2008-10-13
• Study First Submitted QC: 2008-10-14
• Study First Posted: 2008-10-15
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-12
• Last Update Posted: 2008-11-13
• Study Completion: 2009-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	lanreotide	lanreotide

Primary Outcome Measures

Name	Time	Method
Liver volume reduction	24 weeks

Secondary Outcome Measures

Name	Time	Method
Kidney volume Cyst volume	24 weeks

Trial Locations

Locations (2)

University Hospital Gasthuisberg, University of Leuven; 🇧🇪 Leuven, Belgium

Radboud University Nijmegen Medical Center; 🇳🇱 Nijmegen, Netherlands