Pilot Study Of Long-Acting Octreotide (Octreotide LAR® Depot) In The Treatment Of Patients With Severe Polycystic Liver Disease
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 treatments such as liver cyst fenestration, liver resection or liver
transplantation compared with placebo. The secondary aims of the study are: (1)Assess the
effect of Octreotide LAR® Depot on the total kidney volume and iothalamate clearance in
patients with polycystic kidney disease associated with severe polycystic liver disease who
are not candidates or decline surgical treatments such as liver cyst fenestration, liver
resection or liver transplantation. (2)Evaluate quality of life changes associated with the
administration of Octreotide LAR® Depot in these patients. (3)Assess toxicity of Octreotide
LAR® Depot in patients with polycystic liver disease (PLD).
Note: Subjects who completed this 1 year randomized trial were offered enrollment into an
open-label (all subjects received Octreotide) extension trial for an additional two years of
treatment.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Percent Change in Liver Volume
Percent change from baseline in liver volume, measured in milliliters by Magnetic Resonance Imaging (MRI)or Computed Tomography (CT) scans
Baseline, 12 months
No
Marie C. Hogan, M.D., Ph.D.
Principal Investigator
Mayo Clinic
United States: Institutional Review Board
06-004128
NCT00426153
January 2007
October 2008
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |