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PiSCATIN - Simvastatin for the treatment of primary sclerosing cholangitis (PSC) - a randomized double-blind, placebo-controlled multicenter study
EU CTIS ID: 2024-511053-22-00
What this study is testing
Does treatment with simvastatin prolong survival free from bile duct cancer, variceal bleeding and transplantation in PSC?
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.