Octreotide in Severe Polycystic Liver Disease
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Polycystic Kidney, Autosomal Dominant, Polycystic Liver Disease, Hepatomegaly, Liver Diseases, Kidney, Polycystic, Abdominal Pain
In brief
This study will evaluate the effect of Octreotide LAR® on the liver volumes of patients with severe polycystic liver disease who are not candidates or decline surgical treatments such as liver cyst fenestration, liver resection or liver transplantation. A total of 42 patients will be recruited -14 who will receive placebo and 28 the study drug. Preliminary evidence indicates that this drug is safe and non-toxic in other disease states. Treatment with this drug holds promise not only for individuals with liver involvement, but also for many more patients with polycystic kidney disease.
Key facts
- Study ID
- NCT00426153
- Run by
- Mayo Clinic
- People needed
- 42
- Starts
- 2007-01-01
- Expected to finish
- 2008-10-01
- Last updated by the study team
- 2012-11-21
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age - 18 years and older
- Diagnosis of Polycystic Liver Disease (PLD) associated with ADPKD or isolated Autosomal Dominant Polycystic liver Disease (ADPLD)
- Severe PLD defined as a liver volume greater than 4000 mL or symptomatic disease due to mass effects from hepatic cysts
- Not a candidate for or declining surgical intervention
You may not qualify if…
- Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception
- Creatinine greater than 3mg/dL or hemodialysis dependent
- Cancer or major systemic disease that could prevent completion of the planned follow-up or interfere with data collection or interpretation
- Uncontrolled diabetes mellitus as defined by blood glucose levels of greater than or equal to 250 mg/dL on 2 or more consecutive daily readings despite antidiabetic therapy
- Neurologic/psychologic conditions preventing appropriate informed consent
- Symptomatic gallstones or biliary sludge
- Variceal bleeding or hepatic encephalopathy within prior 30 days
- Uncontrolled hypertension (Systolic blood pressure greater than 160 mmHg; Diastolic blood pressure greater than 100 mmHg)
- Current, or prior use of somatostatin analogue (octreotide, lanreotide) in past 6 months
- History of significant adverse reaction to a somatostatin analogue
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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