71 Participants Needed

CAM2029 for Polycystic Liver Disease

(POSITANO Trial)

Recruiting at 11 trial locations
CA
Overseen ByCamurus AB
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have been treated with a somatostatin analogue (a type of medication) within 3 months before the trial starts.

Who Is on the Research Team?

JD

Joost Drenth, MD

Principal Investigator

Department of Gastroenterology and Hepatology, Radboud UMC Nijmegen, The Netherlands

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have experienced symptoms like bloating or abdominal pain recently.
I am not planning to have surgery for liver cysts during the trial.
I have been diagnosed with PLD, with a specific volume measurement.

Exclusion Criteria

I have cysts outside my liver that may make it unsafe for me to join the trial.
I have been treated with a somatostatin analogue within the last 3 months.
I have severe liver disease (Child-Pugh class C).
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CAM2029 or placebo in a randomized, double-blind manner for 53 weeks

53 weeks
Weekly or bi-weekly visits for subcutaneous injections

Open-label extension

Participants may continue receiving CAM2029 treatment for an additional 120 weeks

120 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CAM2029
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: CAM2029 once weeklyExperimental Treatment1 Intervention
Group II: CAM2029 once every 2 weeksExperimental Treatment2 Interventions
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Camurus AB

Lead Sponsor

Trials
9
Recruited
1,900+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security