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Somatostatin Analogue

CAM2029 for Polycystic Liver Disease (POSITANO Trial)

Phase 2 & 3
Waitlist Available
Led By Joost Drenth, MD
Research Sponsored by Camurus AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Male or female patient, ≥18 years at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening to the safety follow-up, assessed up to approximately 21 months
Awards & highlights

POSITANO Trial Summary

This trial is testing a new treatment for PLD, which is a condition that can cause problems with the liver. The new treatment is being compared to a placebo, and participants will be randomly assigned to one of three groups. The trial will last for 53 weeks, and participants may then choose to continue treatment for an additional 24 weeks.

Who is the study for?
This trial is for adults over 18 with Polycystic Liver Disease (PLD) who have a liver volume of at least 2500 mL/m and experience symptoms like bloating, abdominal pain, or shortness of breath. Candidates should not be planning surgery for PLD during the trial and must not have severe kidney or liver disease, recent PLD surgery, or non-responsiveness to similar treatments.Check my eligibility
What is being tested?
The study tests CAM2029's effectiveness and safety in treating symptomatic PLD. Participants will randomly receive either CAM2029 weekly or biweekly, or a placebo for 53 weeks. Those completing this phase may enter a 24-week extension receiving only CAM2029 using FluidCrystal technology.See study design
What are the potential side effects?
While specific side effects are not listed here, octreotide-based treatments like CAM2029 can typically cause digestive issues such as nausea and cramps, gallstones if predisposed (cholelithiasis), blood sugar changes, injection site reactions, and fatigue.

POSITANO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have experienced symptoms like bloating or abdominal pain recently.
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I am 18 years old or older.
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I am not planning to have surgery for liver cysts during the trial.
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I have been diagnosed with PLD, with a specific volume measurement.

POSITANO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening to the safety follow-up, assessed up to approximately 21 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening to the safety follow-up, assessed up to approximately 21 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Height-adjusted total liver volume (htTLV)
Secondary outcome measures
Adverse events (AEs)
Clinical Global Impression of Severity (CGI-S) score
Estimated glomerular filtration rate (eGFR)
+9 more

Side effects data

From undefined Phase 2 trial • 4 Patients • NCT00005906
25%
Gastrointestinal disorders
25%
Liver function abnormalities
100%
80%
60%
40%
20%
0%
Study treatment Arm
Octreotide

POSITANO Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: CAM2029 once weeklyExperimental Treatment1 Intervention
0.5 mL CAM2029 10 mg, subcutaneous (SC) injection, once weekly
Group II: CAM2029 once every 2 weeksExperimental Treatment2 Interventions
0.5 mL CAM2029 10 mg, SC injection, every 2 weeks and 0.5 mL placebo, SC injection, once every 2 weeks (alternating with CAM2029 dosing)
Group III: PlaceboPlacebo Group1 Intervention
0.5 mL placebo, SC injection, once weekly
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Camurus ABLead Sponsor
8 Previous Clinical Trials
1,791 Total Patients Enrolled
Joost Drenth, MDPrincipal InvestigatorDepartment of Gastroenterology and Hepatology, Radboud UMC Nijmegen, The Netherlands

Media Library

CAM2029 (Somatostatin Analogue) Clinical Trial Eligibility Overview. Trial Name: NCT05281328 — Phase 2 & 3
Polycystic Liver Disease Research Study Groups: CAM2029 once every 2 weeks, CAM2029 once weekly, Placebo
Polycystic Liver Disease Clinical Trial 2023: CAM2029 Highlights & Side Effects. Trial Name: NCT05281328 — Phase 2 & 3
CAM2029 (Somatostatin Analogue) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05281328 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you share how many people are currently signed up for the research project?

"Yes, you are correct. The listing on clinicaltrials.gov currently says that the research team is still recruiting patients for the study. The original posting date was June 28th, 2022 and the most recent update was on September 21st, 2022. 69 individuals are needed for the trial, which will take place at 2 different locations."

Answered by AI

Does this clinical trial have any available openings for new participants?

"Indeed, the information available on clinicaltrials.gov supports that this trial is still recruiting patients. This study was first advertised on June 28th, 2022 and was updated as recently as September 21st, 2022. Currently, they are looking for 69 individuals across 2 sites."

Answered by AI
~23 spots leftby Feb 2025