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

Overview

About this study

The purpose of this trial is to evaluate the effectiveness and safety of 2 treatment regimens of CAM2029 versus placebo in patients with Polycystic Liver Disease (PLD). 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/28/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Marie Hogan, M.D., Ph.D.

Open for enrollment

Contact information:

Cassie Howe

(507) 266-1230

Howe.Cassie@mayo.edu

More information

Publications

Publications are currently not available