Primary sclerosing cholangitis (PSC)
Conditions
Brief summary
Number of days from randomisation to death, Number of days from randomisation to listing of liver transplantation, Number of days from randomisation to first variceal bleeding, Number of days from randomization to diagnosis bile duct cancer, gall bladder cancer or hepatocellular cancer (diagnosed with characteristic x-ray (focal) or histological/cytological diagnosis).
Detailed description
Serumconcentrations of alkaline phosphatase, Serumconcentration of bilirubin, MELD Score, Child Pugh Score, Progress of cholangiographic image with MR, Elastography, Symptoms related to PSC (itching or bacterial colangitis requiring treatment, ascites, encephalopathy), Dysplasia in the biliary tract or gall bladder, Development of colon cancer or dysplasia
Interventions
DRUGSimvastatin Sandoz 40 mg filmdragerade tabletter
DRUGPlacebo for Simvastatin Sandoz 40 mg tablets.
Sponsors
Karolinska University Hospital, Karolinska University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of days from randomisation to death, Number of days from randomisation to listing of liver transplantation, Number of days from randomisation to first variceal bleeding, Number of days from randomization to diagnosis bile duct cancer, gall bladder cancer or hepatocellular cancer (diagnosed with characteristic x-ray (focal) or histological/cytological diagnosis). | — |
Secondary
| Measure | Time frame |
|---|---|
| Serumconcentrations of alkaline phosphatase, Serumconcentration of bilirubin, MELD Score, Child Pugh Score, Progress of cholangiographic image with MR, Elastography, Symptoms related to PSC (itching or bacterial colangitis requiring treatment, ascites, encephalopathy), Dysplasia in the biliary tract or gall bladder, Development of colon cancer or dysplasia | — |
Countries
Sweden
Outcome results
None listed