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NCT05281328 · ClinicalTrials.gov registry record · Phase 2
A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD
A Phase 2 study of Polycystic Liver Disease, sponsored by Camurus AB.
- Active
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
- 11
- Study locations
NCT05281328 is a Phase 2 study of Polycystic Liver Disease that is active but no longer recruiting, run by Camurus AB. The registered enrollment target is 71 participants. The trial reports 11 study locations across 6 states.
The verdict
NCT05281328, a Phase 2 study of Polycystic Liver Disease, is active but no longer recruiting, sponsored by Camurus AB.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
- 11
- Study locations
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG CAM2029
Study Locations (11)
Other
- University Hospitals KU Leuven - Leuven
- Hannover Medical School - Hanover
- Universitätsklinikum Leipzig - Leipzig
- Universitaetsklinikum Müenster - Münster
- Radboud UMC, Department of Gastroenterology and Hepatology - Nijmegen
New York
- Mount Sinai Hospital - New York
- The New York Presbyterian Hospital - New York
Minnesota
- Mayo Clinic - Rochester
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
Texas
- University of Texas Southwestern Medical Center - Dallas
Virginia
- Bon Secours Richmond Community Hospital - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2022-06-28 |
| Est. Completion | 2027-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05281328
The ClinicalTrials.gov registry entry for NCT05281328 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Camurus AB, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Polycystic Liver Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05281328 reports 11 study locations spanning 6 distinct geographic areas - top geographies include Other, New York, Minnesota.
Frequently Asked Questions
What is clinical trial NCT05281328 about?
NCT05281328 is a clinical study titled "A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD". 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...
What is the current status of trial NCT05281328?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2022-06-28. Estimated completion is 2027-08.
What conditions does trial NCT05281328 study?
This clinical trial studies the following conditions: Polycystic Liver Disease.
What interventions are being tested in trial NCT05281328?
The interventions under investigation include: Placebo (DRUG), CAM2029 (DRUG).
Who is sponsoring clinical trial NCT05281328?
This trial is sponsored by Camurus AB, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05281328 being conducted?
This trial has 11 study locations across Minnesota, New York, Pennsylvania, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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