A Randomized, Placebo-controlled, Double-blind, Multi-center Phase 2/3 Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients with Symptomatic Polycystic Liver Disease

Multiple Locations

Overview
The purpose of this trial is to evaluate the effectiveness and safety of 2 treatment regimens of CAM2029 versus placebo in patients with Polycystic Liver Disease (PLD).

Eligibility Criteria

  • Ages 18 and older
  • Diagnosis of PLD (associated with ADPKD or isolated as in ADPLD) as defined by htTLV ≥ 2500 mL/m at screening
  • Has not had surgical intervention for PLD within 3 months before screening

Additional inclusion/exclusion criteria will apply.

Participation

Participation will last 20 months (treatment period- 2/3 participants receive study drug, extension period- all participants receive study drug ) and will require 7-9 visits at Mayo Clinic, Rochester, MN. An additional 6-9 visits will be eligible for home health visits as the study requires weekly subcutaneous injections. Other study procedures include ECGs, MRI scans, gallbladder ultrasounds, blood and urine collections, and questionnaires.

Limited reimbursable expenses include travel, lodging, meals, and parking.

Locations
United States

Minnesota

New York

  • The New York Presbyterian Hospital
  • New York, NY 10065

Pennsylvania

  • Hospital of the University of Pennsylvania
  • Philadelphia, PA 19104

Texas

  • University of Texas Southwestern Medical Center
  • Dallas, TX 75380
  • Contact: William Lee, MD