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Pilot Study Of Long-Acting Octreotide (Octreotide LAR® Depot) In The Treatment Of Patients With Severe Polycystic Liver Disease


Phase 2/Phase 3
18 Years
80 Years
Not Enrolling
Both
Polycystic Kidney, Autosomal Dominant, Polycystic Liver Disease, Hepatomegaly, Liver Diseases, Kidney, Polycystic, Abdominal Pain

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Percent Change in Liver Volume

Outcome Description:

Percent change from baseline in liver volume, measured in milliliters by Magnetic Resonance Imaging (MRI)or Computed Tomography (CT) scans

Outcome Time Frame:

Baseline, 12 months

Safety Issue:

No

Principal Investigator

Marie C. Hogan, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

06-004128

NCT ID:

NCT00426153

Start Date:

January 2007

Completion Date:

October 2008

Related Keywords:

  • Polycystic Kidney, Autosomal Dominant
  • Polycystic Liver Disease
  • Hepatomegaly
  • Liver Diseases
  • Kidney, Polycystic
  • Abdominal Pain
  • Abdominal Pain
  • Hepatomegaly
  • Polycystic Kidney Diseases
  • Liver Diseases
  • Polycystic Kidney, Autosomal Dominant
  • Cysts

Name

Location

Mayo ClinicRochester, Minnesota  55905