Status:
ACTIVE_NOT_RECRUITING
A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD
Lead Sponsor:
Camurus AB
Conditions:
Polycystic Liver Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2027
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT05281328
Start Date
June 28 2022
End Date
August 1 2027
Last Update
December 11 2025
Active Locations (11)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
Mount Sinai Hospital
New York, New York, United States, 10029
3
The New York Presbyterian Hospital
New York, New York, United States, 10065
4
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104