Open-Label Extension of LOCKCYST Trial
This trial is active, not recruiting.
|Conditions||polycystic liver disease, hepatomegaly, liver diseases, polycystic kidney, autosomal dominant|
|Phase||phase 2/phase 3|
|Start date||April 2008|
|End date||October 2008|
|Trial size||54 participants|
|Trial identifier||NCT00771888, NL16194.091.07|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Liver volume reduction
time frame: 24 weeks
Kidney volume Cyst volume
time frame: 24 weeks
Male or female participants from 18 years up to 88 years old.
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
|Official title||Open-Label Extension of the LOCKCYST Trial, LOCKCYST: Long Acting Lnareotide as as Volume Reducing Treatment of Polycystic Livers|
|Principal investigator||Joost PH Drenth, PhD|
|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.|
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