Clinical trial NCT00771888: Open-Label Extension of LOCKCYST Trial
Official title: Open-Label Extension of the LOCKCYST Trial, LOCKCYST: Long Acting Lnareotide as as Volume Reducing Treatment of Polycystic Livers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Polycystic Liver Disease
Hepatomegaly
Liver Diseases
Polycystic Kidney
Autosomal Dominant
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Ipsen
First posted: 2008-10-15
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Liver volume reduction
timeFrame: 24 weeks
Secondary outcomes:
measure: Kidney volume Cyst volume
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg, University of Leuven
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Center
Study officials:
affiliation: Radboud University Nijmegen Medical Center
name: Joost PH Drenth, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Gasthuisberg, University of Leuven
name: Frederik Nevens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Nijmegen Medical Center
name: Loes van Keimpema, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.