PiSCATIN - Simvastatin for the treatment of primary sclerosing cholangitis (PSC) - a randomized double-blind, placebo-controlled multicenter study
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 560
- Locations
- 10
- Primary Endpoint
- Number of days from randomisation to death
Study Overview
Brief Summary
Does treatment with simvastatin prolong survival free from bile duct cancer, variceal bleeding and transplantation in PSC?
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients with a cholangiographically verified PSC and/or liverbiopsy with and without IBD (patients with a present autoimmun hepatit and small duct PSC can be included)
- •Men and women ≥18 years but ≤75 years
- •Patient has given written consent to participate in the study
- •MR/MRCP within 4 months
- •Coloscopy within 24 months if the patient has a known IBD
- •Female of childbearing potential must agree to use a highly efficient method of contraception during the study participation.
Exclusion Criteria
- •Patients on waiting list for transplantation
- •Transplanted patients
- •Patients with severe liver failure ≥ Child B 9 points
- •Previous varices bleeding secondary to end stage liver disease
- •Previous cholangiocarcinoma
- •Patients with secondary sclerosing cholangitis
- •Patients who have been taking any statin medication during the last 3 months
- •Intolerance to statins
- •Pregnancy and breastfeeding
Outcomes
Primary Outcomes
Number of days from randomisation to death
Number of days from randomisation to death
Number of days from randomisation to listing of liver transplantation
Number of days from randomisation to listing of liver transplantation
Number of days from randomisation to first variceal bleeding
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).
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 Outcomes
- 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
Investigators
Annika Bergquist
Scientific
Karolinska University Hospital