POSITANO (POlycystic liver Safety and effIcacy TriAl with subcutaNeous Octreotide
Research type
Research Study
Full title
A randomized, placebo-controlled, double-blind, multi-center trial to assess efficacy and safety of octreotide subcutaneous depot (CAM2029) in patients with symptomatic polycystic liver disease
IRAS ID
1007592
Contact name
Anna Olevik
Contact email
Sponsor organisation
Camurus AB
Eudract number
2021-003764-27
Clinicaltrials.gov Identifier
Research summary
Study is testing a study drug called CAM2029 and the disease that will be studied is polycystic liver disease (PLD), which is a rare genetic disorder of the liver. CAM2029 contains an active ingredient called octreotide. Octreotide is already approved by the UK MHRA & other regulatory authorities for treating other diseases but is not yet approved for PLD. Octreotide has previously been tested in clinical studies in patients with PLD. These studies showed that treatment with octreotide may reduce liver growth in patients with PLD. CAM2029 has already been tested in a small group of patients with other conditions than PLD. CAM2029 is currently being tested in large ongoing phase 3 trials in other conditions.
CAM2029 is new in the way octreotide is given to participants. The technology is called FluidCrystal® and has been approved for use since 2018. With the FluidCrystal® technology the medication will be released in the body over a longer period of time than, for example, pills would do. As the medication is in the body for a longer time, this may reduce the number of times the medication is given.The main purpose of this study is to see if CAM2029 works and is safe for people with PLD. The study will also look at: How the study drug affects the body (“pharmacodynamics”); What the body does to the study drug (“pharmacokinetics”).
Participants will sign the Informed Consent Form prior to having any study procedures. Participants taking part in the study will be in the study for about 22 months, includes:
- Screening period (up to 12 weeks)
- Study treatment period (52 weeks)
- Extension period (24 weeks)
- Follow-up period (4 weeks, about 1 month)Once Informed Consent Form has been signed, the Study Doctor will check the participants medical history. Participants have a physical exam, blood tests, magnetic resonance imaging (MRI) scan. The tests and procedures will confirm if the participant is eligible for the study.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
23/SC/0177
Date of REC Opinion
1 Sep 2023
REC opinion
Further Information Favourable Opinion