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This is a randomized, double-blind, placebo controlled multicenter study.
A total of 700 patients will be included. After an updated powercalculation 560 was condidered enough
The study will include patients with primary sclerosing cholangitis (PSC) for daily intake of 40 mg simvastatin/placebo for 5 years. The aim is to study effect of prognosis of PSC by long term intake of simvastatin. Outcome measures are death, liver transplantation, cholangiocarcinoma or bleeding from esophageal varices.
Subjects will be randomized (1:1) between Simvastatin and placebo.
Please see published protocol
Long Term Effect of Simvastatin in Primary Sclerosing Cholangitits: A Placebo-Controlled, Double-Blind, Multicenter Phase III Study (Piscatin)
A. Bergquist, H. U. Marschall, E. Nilsson, N. Nyhlin, M. Werner, A. Klein, et al.
British Journal of Gastroenterolgy 2022 Vol. 1 Pages 235-241.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simvastatin | Experimental | Simvastatin 40 mg administered orally daily for 5 years. |
|
| Placebo | Placebo Comparator | Placebo for Simvastatin 40 mg administered orally daily for 5 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin 40mg | Drug | 40 mg orally daily for 5 years. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival from time to randomization to death from any cause. | Time from the date of randomization to the date of death, assessed up to 5 years. |
| Listing for liver transplantation | Date the subject is getting registered on the waiting list for liver transplantation. | Time from the date of randomization to the date of listing for liver transplantation, assessed up to 5 years. |
| Time to first varices bleeding | Date of the subject's first varices bleeding according to hospital patient records. | Time from the date of randomization to the date of the first varices bleeding, assessed up to 5 years. |
| Time to diagnosis of cholangiocarcinoma, gall bladder cancer, or hepatocellular cancer. | Diagnosis of cancer of bile duct cancer or gall bladder, or hepatocellular cancer according to hospital patient records. | Time from the date of randomization to cancer diagnosis, assessed up to 5 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on serum concentration of alkaline phosphatase (ALP). | Assessment of changes in the serum concentration of alkaline phosphatase. | Assessed yearly up to 5 years. |
| Effect on serum concentration of bilirubin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annika Bergquist, MD PhD | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skåne Universitetssjukhus | Malmö | Skåne County | 222 42 | Sweden | ||
| Norrlands Universitetssjukhus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39601354 | Derived | Lindqvist C, Ingre M, Kechagias S, Nilsson E, Molinaro A, Rorsman F, Bergquist A. Dietary Habits of Individuals With Primary Sclerosing Cholangitis-Poor Fat-Soluble Vitamin Intake and Dietary Quality. Liver Int. 2025 Apr;45(4):e16182. doi: 10.1111/liv.16182. Epub 2024 Nov 27. |
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| ID | Term |
|---|---|
| D015209 | Cholangitis, Sclerosing |
| ID | Term |
|---|---|
| D002761 | Cholangitis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo oral tablet |
| Drug |
40 mg orally daily for 5 years. |
|
Assessment of changes in the serum concentration of bilirubin.
| Assessed yearly up to 5 years. |
| Effect on the progress of PSC by liver failure measurement | Assessment of liver failure using Model for End Stage Liver Disease (MELD) Score (biochemical and clinical variables). | Assessed at every visit except the 3 months visit, up to 5 years. |
| Effect on the progress of PSC by liver failure measurement. | Assessment of liver failure using Child Pugh Score | Assessed at every visit except the 3 months visit, up to 5 years. |
| Effect on the progress of PSC assessed by cholangiography at MRI. | Progress assessed by cholangiography MRI | Assessed at inclusion and the 60 months visit. |
| Effect on the progress of PSC assessed by elastography | Assessment of fibrosis stage using elastography. | Assessed yearly up to 5 years. |
| Effect on the progress of PSC assessed by clinical symptoms | Assessment of symptoms including itching and bacterial cholangitis that requires treatment, ascites and encephalopathy. | Assessed yearly up to 5 years. |
| Effect on the progress of PSC assessed by measurement of biliary dysplasia | Biliary dysplasia from brush samples taken at endoscopic retrograde cholangiopancreatography (ERCP). | Assessed upon clinical indication, up to 5 years. |
| Effect on the development of colon cancer or colon dysplasia. | Development of colon cancer and/or colon dysplasia according to hospital patient records. | Assessed at 60 months. |
| Effect on the progress of PSC assessed by serum fibrosis markers | Fib-4, ELF (if funded) | Assessed yearly up to 5 years |
| Umeå |
| Västerbotten County |
| 907 37 |
| Sweden |
| Sahlgrenska Universitetssjukhuset | Gothenburg | Västra Götaland County | 413 45 | Sweden |
| Sahlgrenska Universitetssjukhuset Östra | Gothenburg | 41685 | Sweden |
| Karlstads centralsjukhus | Karlstad | 652 30 | Sweden |
| Skaraborgs sjukhus | Lidköping | Sweden |
| Örebro Universitetssjukhus | Örebro | 701 85 | Sweden |
| Karolinska University Hospital | Stockholm | 141 57 | Sweden |
| Karolinska University Hospital Solna | Stockholm | 171 64 | Sweden |
| Danderyds sjukhus | Stockholm | 182 57 | Sweden |
| Akademiska sjukhuset | Uppsala | 751 85 | Sweden |
| Universitetssjukhuset i Linköping | Linköping | Östergötland County | 581 85 | Sweden |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |