Spots Global Cancer Trial Database for A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD
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Trial Identification
Brief Title: A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD
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
Study ID: NCT05281328
Conditions
Study Description
Brief 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 24-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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Hannover, , Germany
Universitätsklinikum Leipzig, Leipzig, , Germany
Universitaetsklinikum Müenster, Münster, , Germany
Radboud UMC, Department of Gastroenterology and Hepatology, Nijmegen, , Netherlands
Contact Details
Name: Joost Drenth, MD
Affiliation: Department of Gastroenterology and Hepatology, Radboud UMC Nijmegen, The Netherlands
Role: PRINCIPAL_INVESTIGATOR
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