Table of Contents
- Trial overview
- Eye surgery recovery study
- Gallstone pancreatitis prevention study
- Immune-related hepatitis study
- Polycystic liver and kidney disease study
- Key points for patients
Trial overview
These studies are testing Ursodeoxycholic Acid in four different patient groups, not for one single disease.[1][2][3][4] The trials are all listed as Authorised, which means they have been approved to start.[1][2][3][4] Three studies are in Phase 3, and one study is in Phase 2.[1][2][3][4]
Eye surgery recovery study
One Phase 3 trial is studying whether Ursodeoxycholic Acid can help visual recovery after surgery for rhegmatogenous retinal detachment, which is a retinal tear that can cause vision loss.[1] The trial includes pseudophakic or aphakic patients, meaning patients with an artificial lens or without a natural lens in the eye.[1]
The study asks whether visual acuity, which means how clearly a person can see, improves more in the Ursodeoxycholic Acid group than in the placebo group after successful retinal reattachment surgery.[1] The main endpoint is the difference between pre-operative and 3-month post-operative visual acuity on the EDTRS scale.[1] The trial plans to enroll 120 people.[1]
Gallstone pancreatitis prevention study
Another Phase 3 study is looking at people who had a first episode of acute biliary pancreatitis, which is inflammation of the pancreas caused by gallstones or bile problems.[2] The trial is testing whether Ursodeoxycholic Acid can reduce later problems linked to gallstones, compared with placebo and standard follow-up until gallbladder removal or up to one year.[2]
The main outcome is death or a gallstone-related complication, such as a new pancreatitis episode, cholangitis, cholecystitis, choledocholithiasis, or biliary colic.[2] This study plans to enroll 332 participants.[2]
Immune-related hepatitis study
The CHILURSO trial is a Phase 3 study in patients with cholestatic hepatitis induced by immune checkpoint inhibitors, which is a liver injury pattern linked to cancer immunotherapy.[3] It compares Ursodeoxycholic Acid with corticosteroids, a type of anti-inflammatory medicine often used to calm immune reactions.[3]
The primary endpoint is the share of patients who improve by at least 25% in liver function tests, especially alkaline phosphatase and/or gamma-GT, by Day 21.[3] The trial plans to enroll 94 participants.[3]
Polycystic liver and kidney disease study
A Phase 2 trial is studying Ursodeoxycholic Acid in hepatorenal polycystic diseases, which are genetic diseases that cause cysts in the liver and kidneys.[4] The study compares Ursodeoxycholic Acid with placebo and looks at whether it can slow disease progression by reducing the growth of liver cysts.[4]
The main endpoint is the absolute and percentage change in total liver cyst volume from the start to the end of treatment between the two groups.[4] The trial plans to enroll 138 participants.[4]
Key points for patients
These trials are not studying the same outcome, so the results cannot be mixed together.[1][2][3][4] Each study uses a different patient group, a different comparison treatment, and a different main endpoint.[1][2][3][4]
In simple terms, the research is asking whether Ursodeoxycholic Acid can improve vision after eye surgery, prevent later gallstone-related problems, improve liver tests in immune-related hepatitis, or slow liver cyst growth in polycystic disease.[1][2][3][4]
