Open-Label Extension of LOCKCYST Trial (LOCKCYST-ext)
Recruitment status was Active, not recruiting
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.
Polycystic Liver Disease
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
- Liver volume reduction [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Kidney volume Cyst volume [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2008|
|Estimated Study Completion Date:||August 2009|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
van Keimpema L, de Man RA, Drenth JP. Somatostatin analogues reduce liver volume in polycystic liver disease. Gut 2008 September;57(9):1338-9.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00771888
|University Hospital Gasthuisberg, University of Leuven|
|Radboud University Nijmegen Medical Center|
|Nijmegen, Netherlands, 6500 HB|
|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|