🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Germany / NCT05281328
Active, not recruiting Phase 2/3

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

NCT05281328 · tracked via the Priya Life Science Germany tracker
Sponsor
Phase
Phase 2/3
Started
2022-06-28
Last updated
2026-06-01

Condition(s) studied

Polycystic Liver Disease

Investigational drug(s) / intervention(s)

CAM2029 →Placebo

CAM2029: SC injection using a pre-filled pen

Placebo: SC injection using a pre-filled pen

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Male or female patient, ≥18 years at screening * Diagnosis of PLD (associated with ADPKD or isolated as in ADPLD) as defined by htTLV ≥1800 mL/m at screening * Presence of at least 1 of the following PLD-related symptoms within 2 weeks before screening: bloating, fullness in abdomen, lack of appetite, feeling full quickly after beginning to eat, acid reflux, nausea, rib cage pain or pressure, pain in side, abdominal pain, back pain, shortness of breath after physical exertion, limited in mobility, concern about abdomen getting larger, dissatisfied by the size of abdomen * Not a candidate for, or not willing to undergo, surgical intervention for hepatic cysts during the trial Exclusion Criteria: * Surgical intervention for PLD within 3 months before screening * Treatment with a somatostatin analogue (SSA) within 3 months before screening * Non-responsive to previous treatment of PLD with an SSA as per the Investigator's assessment * Systematic cholelithiasis within 3 months before screening or previous medical history of cholelithiasis induced by SSAs unless treated with cholecystectomy * Presence of extrahepatic cysts that, in the Investigator's opinion, may prevent the patient from safely participating in the trial * Severe kidney disease, as defined by eGFR \<30 mL/min/1.73\^m2 * Severe liver disease defined as liver cirrhosis of Child-Pugh class C * Any other current or prior medical condition that may interfere with the conduct of the trial or the evaluation of its results in the opinion of the Investigator

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
Mayo Clinic Rochester Minnesota
Mount Sinai Hospital New York New York
The New York Presbyterian Hospital New York New York
Hospital of the University of Pennsylvania Philadelphia Pennsylvania
University of Texas Southwestern Medical Center Dallas Texas
Bon Secours Richmond Community Hospital Richmond Virginia
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

More Camurus AB trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05281328 on ClinicalTrials.gov ↗ ← All trials in Germany