A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD

Launched by CAMURUS AB · Mar 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called CAM2029, which contains octreotide, to see how well it works and how safe it is for people with Polycystic Liver Disease (PLD). The trial compares two different treatment schedules—one where the medication is given every week and another where it’s given every two weeks—against a placebo (a treatment that doesn’t contain the active drug) in patients who have symptoms related to PLD. It’s open to adults aged 18 and older who have been diagnosed with PLD and are experiencing related symptoms like abdominal pain, feeling bloated, or lack of appetite. However, those who have had recent surgery for PLD or certain severe health conditions might not be eligible.

Participants in the trial will be randomly assigned to receive one of the treatments for 53 weeks. After this initial period, they may continue in a longer phase of the study for an additional 120 weeks where they will receive the same treatment. The medication is given as an injection under the skin using a special technology that helps it work effectively. This trial is currently active but not recruiting new participants, so it’s important to check with your healthcare provider for any updates or options if you’re interested in this type of treatment.

Gender

ALL

Eligibility criteria

• 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 ≥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 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
• • 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