Status:
UNKNOWN
Open-Label Extension of LOCKCYST Trial
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Ipsen
Conditions:
Polycystic Liver Disease
Hepatomegaly
Eligibility:
All Genders
18-88 years
Phase:
PHASE2
PHASE3
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...
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
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00771888
Start Date
April 1 2008
End Date
August 1 2009
Last Update
November 13 2008
Active Locations (2)
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1
University Hospital Gasthuisberg, University of Leuven
Leuven, Belgium
2
Radboud University Nijmegen Medical Center
Nijmegen, Netherlands, 6500 HB