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A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD
Sponsor: Camurus AB
Summary
The purpose of the trial is to compare the effectiveness and safety of 2 treatment regimens of CAM2029 (given weekly or every 2 weeks) to placebo in participants with symptomatic PLD, either isolated as in autosomal dominant PLD (ADPLD) or associated with autosomal dominant polycystic kidney disease (ADPKD). In the Treatment Period of the trial, participants will be allocated at random to 1 of the 3 treatment arms in a 1:1:1 ratio. After completing the Treatment Period (53 weeks) participants may proceed to a 120-week open-label extension part of the trial and then only receive the same CAM2029 treatment. The active ingredient in CAM2029, octreotide, is administered as a subcutaneous depot using Camurus' FluidCrystal® technology.
Official title: A Randomized, Placebo-controlled, Double-blind, Multi-center Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Symptomatic Polycystic Liver Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
71
Start Date
2022-06-28
Completion Date
2027-08
Last Updated
2025-12-11
Healthy Volunteers
No
Conditions
Interventions
CAM2029
SC injection using a pre-filled pen
Placebo
SC injection using a pre-filled pen
Locations (11)
Mayo Clinic
Rochester, Minnesota, United States
Mount Sinai Hospital
New York, New York, United States
The New York Presbyterian Hospital
New York, New York, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Bon Secours Richmond Community Hospital
Richmond, Virginia, United States
University Hospitals KU Leuven
Leuven, Belgium
Hannover Medical School
Hanover, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Universitaetsklinikum Müenster
Münster, Germany
Radboud UMC, Department of Gastroenterology and Hepatology
Nijmegen, Netherlands