Octreotide in Severe Polycystic Liver Disease

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborators: National Center for Research Resources (NCRR); Novartis
• Treatments: Octreotide

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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