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Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC) (PiSCATIN)

Primary Purpose

Primary Sclerosing Cholangitis

Status
Recruiting
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Simvastatin 40mg
Placebo oral tablet
Sponsored by
Annika Bergquist
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Sclerosing Cholangitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • PSC verified by cholangiography or liver biopsy, with or without irritable bowel disease (IBD).
  • Men and women between ≥18 years and ≤75 years.
  • Written informed consent.
  • A magnetic resonance imaging (MRI) or Magnetic resonance cholangiopancreatography (MRCP) performed within 4 months prior to randomization.
  • Colonoscopy performed within 24 months prior to randomization, if known IBD.
  • For women of childbearing potential efficient contraceptive.

Exclusion Criteria:

  • Subjects on waiting list for transplantation
  • Transplanted subjects
  • Previous variceal bleeding
  • Previous hepatobiliary malignancy
  • Subjects with secondary sclerosing cholangitis
  • Intake of any type of statins within 3 months prior to randmization
  • Known intolerance to simvastatin.
  • Pregnancy or breastfeeding.

Sites / Locations

  • Skåne UniversitetssjukhusRecruiting
  • Norrlands UniversitetssjukhusRecruiting
  • Sahlgrenska UniversitetssjukhusetRecruiting
  • Södra Älvsborgs sjukhus
  • Sahlgrenska Universitetssjukhuset ÖstraRecruiting
  • Karlstads centralsjukhusRecruiting
  • Capio S:t Görans sjukhusRecruiting
  • Ersta sjukhus
  • Karolinska University HospitalRecruiting
  • Karolinska University Hospital SolnaRecruiting
  • Danderyds sjukhusRecruiting
  • Norra Älvsborgs länssjukhus
  • Akademiska sjukhusetRecruiting
  • Örebro UniversitetssjukhusRecruiting
  • Universitetssjukhuset i LinköpingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Simvastatin

Placebo

Arm Description

Simvastatin 40 mg administered orally daily for 5 years.

Placebo for Simvastatin 40 mg administered orally daily for 5 years.

Outcomes

Primary Outcome Measures

Overall survival
Overall survival from time to randomization to death from any cause.
Listing for liver transplantation
Date the subject is getting registered on the waiting list for liver transplantation.
Time to first varices bleeding
Date of the subject's first varices bleeding according to hospital patient records.
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.

Secondary Outcome Measures

Effect on serum concentration of alkaline phosphatase (ALP).
Assessment of changes in the serum concentration of alkaline phosphatase.
Effect on serum concentration of bilirubin
Assessment of changes in the serum concentration of bilirubin.
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).
Effect on the progress of PSC by liver failure measurement.
Assessment of liver failure using Child Pugh Score
Effect on the progress of PSC assessed by cholangiography at MRI.
Progress assessed by cholangiography MRI
Effect on the progress of PSC assessed by elastography
Assessment of fibrosis stage using elastography.
Effect on the progress of PSC assessed by clinical symptoms
Assessment of symptoms including itching and bacterial cholangitis that requires treatment, ascites and encephalopathy.
Effect on the progress of PSC assessed by measurement of biliary dysplasia
Biliary dysplasia from brush samples taken at endoscopic retrograde cholangiopancreatography (ERCP).
Effect on the development of colon cancer or colon dysplasia.
Development of colon cancer and/or colon dysplasia according to hospital patient records.
Effect on the progress of PSC assessed by serum fibrosis markers
Fib-4, ELF (if funded)

Full Information

First Posted
October 17, 2019
Last Updated
October 31, 2022
Sponsor
Annika Bergquist
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1. Study Identification

Unique Protocol Identification Number
NCT04133792
Brief Title
Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC)
Acronym
PiSCATIN
Official Title
Effect of Simvastatin on the Prognosis of Primary Sclerosing Cholangitis (PSC); A Randomized, Double-blind, Placebo Controlled Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
May 15, 2027 (Anticipated)
Study Completion Date
May 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Annika Bergquist

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized, double-blind, placebo controlled multicenter study. A total of 700 patients will be included. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Sclerosing Cholangitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Simvastatin
Arm Type
Experimental
Arm Description
Simvastatin 40 mg administered orally daily for 5 years.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for Simvastatin 40 mg administered orally daily for 5 years.
Intervention Type
Drug
Intervention Name(s)
Simvastatin 40mg
Intervention Description
40 mg orally daily for 5 years.
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
40 mg orally daily for 5 years.
Primary Outcome Measure Information:
Title
Overall survival
Description
Overall survival from time to randomization to death from any cause.
Time Frame
Time from the date of randomization to the date of death, assessed up to 5 years.
Title
Listing for liver transplantation
Description
Date the subject is getting registered on the waiting list for liver transplantation.
Time Frame
Time from the date of randomization to the date of listing for liver transplantation, assessed up to 5 years.
Title
Time to first varices bleeding
Description
Date of the subject's first varices bleeding according to hospital patient records.
Time Frame
Time from the date of randomization to the date of the first varices bleeding, assessed up to 5 years.
Title
Time to diagnosis of cholangiocarcinoma, gall bladder cancer, or hepatocellular cancer.
Description
Diagnosis of cancer of bile duct cancer or gall bladder, or hepatocellular cancer according to hospital patient records.
Time Frame
Time from the date of randomization to cancer diagnosis, assessed up to 5 years.
Secondary Outcome Measure Information:
Title
Effect on serum concentration of alkaline phosphatase (ALP).
Description
Assessment of changes in the serum concentration of alkaline phosphatase.
Time Frame
Assessed yearly up to 5 years.
Title
Effect on serum concentration of bilirubin
Description
Assessment of changes in the serum concentration of bilirubin.
Time Frame
Assessed yearly up to 5 years.
Title
Effect on the progress of PSC by liver failure measurement
Description
Assessment of liver failure using Model for End Stage Liver Disease (MELD) Score (biochemical and clinical variables).
Time Frame
Assessed at every visit except the 3 months visit, up to 5 years.
Title
Effect on the progress of PSC by liver failure measurement.
Description
Assessment of liver failure using Child Pugh Score
Time Frame
Assessed at every visit except the 3 months visit, up to 5 years.
Title
Effect on the progress of PSC assessed by cholangiography at MRI.
Description
Progress assessed by cholangiography MRI
Time Frame
Assessed at inclusion and the 60 months visit.
Title
Effect on the progress of PSC assessed by elastography
Description
Assessment of fibrosis stage using elastography.
Time Frame
Assessed yearly up to 5 years.
Title
Effect on the progress of PSC assessed by clinical symptoms
Description
Assessment of symptoms including itching and bacterial cholangitis that requires treatment, ascites and encephalopathy.
Time Frame
Assessed yearly up to 5 years.
Title
Effect on the progress of PSC assessed by measurement of biliary dysplasia
Description
Biliary dysplasia from brush samples taken at endoscopic retrograde cholangiopancreatography (ERCP).
Time Frame
Assessed upon clinical indication, up to 5 years.
Title
Effect on the development of colon cancer or colon dysplasia.
Description
Development of colon cancer and/or colon dysplasia according to hospital patient records.
Time Frame
Assessed at 60 months.
Title
Effect on the progress of PSC assessed by serum fibrosis markers
Description
Fib-4, ELF (if funded)
Time Frame
Assessed yearly up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: PSC verified by cholangiography or liver biopsy, with or without irritable bowel disease (IBD). Men and women between ≥18 years and ≤75 years. Written informed consent. A magnetic resonance imaging (MRI) or Magnetic resonance cholangiopancreatography (MRCP) performed within 4 months prior to randomization. Colonoscopy performed within 24 months prior to randomization, if known IBD. For women of childbearing potential efficient contraceptive. Exclusion Criteria: Subjects on waiting list for transplantation Transplanted subjects Previous variceal bleeding Previous hepatobiliary malignancy Subjects with secondary sclerosing cholangitis Intake of any type of statins within 3 months prior to randmization Known intolerance to simvastatin. Pregnancy or breastfeeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annika Bergquist, MD PhD
Phone
0707214907
Ext
+46
Email
annika.bergquist@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Klein, PhD
Phone
08-524 837 32
Ext
+46
Email
amanda.klein@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annika Bergquist, MD PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skåne Universitetssjukhus
City
Malmö
State/Province
Skåne
ZIP/Postal Code
222 42
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Nilsson
First Name & Middle Initial & Last Name & Degree
emma.nilsson@skane.se
First Name & Middle Initial & Last Name & Degree
Emma Nilsson
Facility Name
Norrlands Universitetssjukhus
City
Umeå
State/Province
Västerbotten
ZIP/Postal Code
907 37
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mårten Werner
Email
marten.warner@umu.se
First Name & Middle Initial & Last Name & Degree
Mårten Warner
Facility Name
Sahlgrenska Universitetssjukhuset
City
Göteborg
State/Province
Västra Götaland
ZIP/Postal Code
413 45
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanns-Ulrich Marschall
Email
hanns-ulrich.marschall@gu.se
First Name & Middle Initial & Last Name & Degree
Hanns-Ulrich Marschall
Facility Name
Södra Älvsborgs sjukhus
City
Borås
ZIP/Postal Code
501 82
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iris Posserud
Email
iris.posserud@vgregion.se
First Name & Middle Initial & Last Name & Degree
Marie A Andersson
Email
marie.a.andersson@vgregion.se
First Name & Middle Initial & Last Name & Degree
Iris Posserud
Facility Name
Sahlgrenska Universitetssjukhuset Östra
City
Göteborg
ZIP/Postal Code
41685
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikolaos Papachrysos
Email
nikolaos.papachrysos@vgregion.se
First Name & Middle Initial & Last Name & Degree
Elin Hultgren
Email
elin.hultgren@vgregion.se
First Name & Middle Initial & Last Name & Degree
Nikolaos Papachrysos
Facility Name
Karlstads centralsjukhus
City
Karlstad
ZIP/Postal Code
652 30
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Imanté Lasyté
Email
imante.lasyte@regionvarmland.se
First Name & Middle Initial & Last Name & Degree
Theres Holmblad
Email
theres.holmblad@regionvarmland.se
First Name & Middle Initial & Last Name & Degree
Imanté Lasyté
Facility Name
Capio S:t Görans sjukhus
City
Stockholm
ZIP/Postal Code
112 19
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Söderman
Email
charlotte.soderman@capiostgoran.se
First Name & Middle Initial & Last Name & Degree
Charlotte Söderman
Facility Name
Ersta sjukhus
City
Stockholm
ZIP/Postal Code
116 28
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Izabella Jancewska
First Name & Middle Initial & Last Name & Degree
izabella.janczewska@erstadiakoni.se
First Name & Middle Initial & Last Name & Degree
Izabella Jancewska
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
141 57
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annika Bergquist
Phone
70 7214907
Ext
460
Email
annika.bergquist@ki.se
First Name & Middle Initial & Last Name & Degree
Susanne Bouiche
First Name & Middle Initial & Last Name & Degree
Annika Bergquist
Facility Name
Karolinska University Hospital Solna
City
Stockholm
ZIP/Postal Code
171 64
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Hedin
Email
charlotte.hedin@ki.se
First Name & Middle Initial & Last Name & Degree
Charlotta Hedin
Facility Name
Danderyds sjukhus
City
Stockholm
ZIP/Postal Code
182 57
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikael Lördal
Email
mikael.lordal@sll.se
First Name & Middle Initial & Last Name & Degree
Mikael Lördal
Facility Name
Norra Älvsborgs länssjukhus
City
Trollhättan
ZIP/Postal Code
461 73
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Knutsson
Email
marie.knutsson@vgregion.se
First Name & Middle Initial & Last Name & Degree
Marie Knutsson
Facility Name
Akademiska sjukhuset
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fredrik Rorsman
Email
fredrik.rorsman@medsci.uu.se
First Name & Middle Initial & Last Name & Degree
Fredrik Rorsman
Facility Name
Örebro Universitetssjukhus
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nils Nyhlin
Email
nils.nyhlin@regionorebrolan.se
First Name & Middle Initial & Last Name & Degree
Nils Nyhlin
Facility Name
Universitetssjukhuset i Linköping
City
Linköping
State/Province
Östergötland
ZIP/Postal Code
581 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stergios Kechagias
Email
stergios.kechagias@liu.se
First Name & Middle Initial & Last Name & Degree
Stergios Kechagias

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC)

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