Octreotide in Severe Polycystic Liver Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00426153
• Date of registration: 22/01/2007
• Prospective Registration: No
• Primary sponsor: Mayo Clinic
• Public title: Octreotide in Severe Polycystic Liver Disease
• Scientific title: Pilot Study Of Long-Acting Octreotide (Octreotide LAR® Depot) In The Treatment Of Patients With Severe Polycystic Liver Disease
• Date of first enrolment: January 2007
• Target sample size: 42
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00426153
• Study type: Interventional
• Phase: Phase 2/Phase 3

Countries of recruitment

United States

Contacts

• Name: Marie C. Hogan, M.D., Ph.D.
• Affiliation: Mayo Clinic

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Liver Diseases

Polycystic Kidney, Autosomal Dominant

Abdominal Pain

Kidney, Polycystic

Polycystic Liver Disease

Hepatomegaly

Intervention(s)

Drug: Octreotide

Drug: Placebo

Primary Outcome(s)

Percent Change in Liver Volume [Time Frame: Baseline, 12 months]

Secondary Outcome(s)

Change in Subject Reported Outcomes Using Mean Health Related Quality of Life (HRQoL) Scores [Time Frame: Baseline, 12 months]

Percent Change in Glomerular Filtration Rate (GFR) [Time Frame: Baseline, 12 months]

Percent Change in Renal Volume [Time Frame: Baseline, 12 months]

Secondary ID(s)

06-004128

UL1RR024150

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Center for Research Resources (NCRR)

Novartis

Results

• Results available: Yes
• Date Posted: 21/11/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00426153