Open-Label Extension of LOCKCYST Trial (LOCKCYST-ext)
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|ClinicalTrials.gov 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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- Liver volume reduction [ Time Frame: 24 weeks ]
- Kidney volume Cyst volume [ Time Frame: 24 weeks ]
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 ClinicalTrials.gov identifier (NCT number): 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|