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ACTIVE NOT RECRUITING
NCT05281328
PHASE2/PHASE3

A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD

Sponsor: Camurus AB

View on ClinicalTrials.gov

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

Interventions

DRUG

CAM2029

SC injection using a pre-filled pen

DRUG

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