Status:
COMPLETED
Octreotide in Severe Polycystic Liver Disease
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Novartis
National Center for Research Resources (NCRR)
Conditions:
Polycystic Kidney, Autosomal Dominant
Polycystic Liver Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief 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 fe...
Detailed Description
The primary aim of this study is to compare the effect of Octreotide LAR® Depot on the liver volume of patients with severe polycystic liver disease who are not candidates or decline surgical treatmen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00426153
Start Date
January 1 2007
End Date
October 1 2008
Last Update
November 21 2012
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905