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Pasireotide LAR in Severe Polycystic Liver Disease

NCT01670110 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-05-01

Study results available
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Summary

The purpose of this study is to compare SOM230 treatment to placebo. The investigators will also assess the efficacy and safety of SOM230 in reducing total liver volume and improving quality of life.

Conditions

  • Somatostatin Analogs
  • Polycystic Liver Disease
  • Autosomal Dominant Polycystic Kidney Disease
  • Autosomal Dominant Polycystic Liver Disease

Interventions

DRUG

Pasireotide LAR

Injectible, 60mg per month

DRUG

Placebo

To be injected once per month

Sponsors & Collaborators

Principal Investigators

  • Marie C Hogan, MD PhD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2018-09-30
Completion
2018-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01670110 on ClinicalTrials.gov