A Randomized, Placebo-controlled, Double-blind, Multi-center Phase 2/3 Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Symptomatic Polycystic Liver Disease (POSITANO)

  • STATUS
    Recruiting
  • End date
    Aug 17, 2024
  • participants needed
    69
  • sponsor
    Camurus AB
Updated on 17 September 2022

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 24-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.

Details
Condition Polycystic Liver Disease
Treatment Placebo, CAM2029
Clinical Study IdentifierNCT05281328
SponsorCamurus AB
Last Modified on17 September 2022

Eligibility

Yes No Not Sure

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 ≥2500 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
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
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