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Double blind, multicentric, randomized, placebo-controlled trial, evaluating the efficacy of 24-month of bezafibrate in primary sclerosing cholangitis with persistent cholestasis despite ursodeoxycholic acid therapy (BEZASCLER
EU CTIS ID: 2024-511658-28-01
What this study is testing
To assess the efficacy of 24-month treatment with bezafibrate (400 mg SR/d) versus placebo in addition to standard UDCA therapy in primary sclerosing cholangitis
- Therapeutic confirmatory (Phase III)
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
- • Males or females ≥ 18 and ≤ 75 years
- • Large duct PSC verified by retrograde, operative, percutaneous or magnetic resonance cholangiography (MRC) demonstrating intrahepatic and /or extrahepatic biliary duct changes consistent with PSC
- • Colonoscopy (already done or scheduled before randomization) within the last 5 years (or within 6 months if IBD is associated to PSC) with neither cancer nor all-grade dysplasia or endoscopy of the ileal reservoir (already done or scheduled before randomization) within the last 2 years in patients with ileo-anal anastomosis.
- • ALP ≥ 1.5 ULN
- • Traitement par l'AUDC (13-23 mg/kg/j) depuis ≥ 6 mois avant l'inclusion (Arrondi à l’unité le plus proche, par exemple 12.5 mg/kg/j arrondi à 13 mg/kg/j)
- • Using contraceptive in women of childbearing potential. Women of childbearing potential, i.e. fertile, following menarche and until becoming post-menopaused unless permanently sterile, who are sexually active have to apply a highly effective method of birth control with a low failure rate (i.e. less than 1% per year) when used constantly and correctly.
You likely can't join if
- • Child-Pugh score B or C
- • Treatment with a fibrate within the last 3 months inclusion
- • Current active IBD defined as either current use of systemic corticosteroid therapy > 10 mg/day or budesonide > 3 mg /day or immunosuppressive drugs (cyclosporine, tacrolimus, mycophenolate mofetil, mTor inhibitors, JAK inhibitors) or a partial Mayo score > 2 in patients with ulcerative colitis (UC), unclassed colitis or a Crohn’s Disease Activity Index (CDAI) > 150 in patients with Crohn’s disease (CD)
- • Dosage change of treatment for associated IBD ≤3 months prior to inclusion
- • Current or history of colonic cancer or all-grade dysplasia described at the last colonoscopy (Patients with a history of colon cancer and treated by total colectomy without recurrence for at least 5 years are eligible)
- • Any other cause of liver damage ((positive test for HBV, HCV, or HIV, excessive alcohol consumption, hemochromatosis, Wilson's disease, α1-antitrypsin deficiency, celiac disease
See the full eligibility criteria
Who can join
- • Males or females ≥ 18 and ≤ 75 years
- • Large duct PSC verified by retrograde, operative, percutaneous or magnetic resonance cholangiography (MRC) demonstrating intrahepatic and /or extrahepatic biliary duct changes consistent with PSC
- • Colonoscopy (already done or scheduled before randomization) within the last 5 years (or within 6 months if IBD is associated to PSC) with neither cancer nor all-grade dysplasia or endoscopy of the ileal reservoir (already done or scheduled before randomization) within the last 2 years in patients with ileo-anal anastomosis.
- • ALP ≥ 1.5 ULN
- • Traitement par l'AUDC (13-23 mg/kg/j) depuis ≥ 6 mois avant l'inclusion (Arrondi à l’unité le plus proche, par exemple 12.5 mg/kg/j arrondi à 13 mg/kg/j)
- • Using contraceptive in women of childbearing potential. Women of childbearing potential, i.e. fertile, following menarche and until becoming post-menopaused unless permanently sterile, who are sexually active have to apply a highly effective method of birth control with a low failure rate (i.e. less than 1% per year) when used constantly and correctly.
- • Affiliation to a social security system (AME excepted)
- • Signed informed consent
What rules you out
- • Child-Pugh score B or C
- • Treatment with a fibrate within the last 3 months inclusion
- • Current active IBD defined as either current use of systemic corticosteroid therapy > 10 mg/day or budesonide > 3 mg /day or immunosuppressive drugs (cyclosporine, tacrolimus, mycophenolate mofetil, mTor inhibitors, JAK inhibitors) or a partial Mayo score > 2 in patients with ulcerative colitis (UC), unclassed colitis or a Crohn’s Disease Activity Index (CDAI) > 150 in patients with Crohn’s disease (CD)
- • Dosage change of treatment for associated IBD ≤3 months prior to inclusion
- • Current or history of colonic cancer or all-grade dysplasia described at the last colonoscopy (Patients with a history of colon cancer and treated by total colectomy without recurrence for at least 5 years are eligible)
- • Any other cause of liver damage ((positive test for HBV, HCV, or HIV, excessive alcohol consumption, hemochromatosis, Wilson's disease, α1-antitrypsin deficiency, celiac disease
- • Current or recent history (within 2 years) of Autoimmune hepatitis defined by the presence of interface hepatitis documented on liver biopsy and at least 1 of the 2 following criteria: 1) AST or ALT > 5 ULN, 2) Positive anti smooth muscle auto antibodies or serum IgG > 1.5 ULN
- • Secondary causes of sclerosing cholangitis including IgG4-associated cholangitis (elevated serum IgG4 > 4 ULN)
- • History of acute cholangitis in the last 3 months prior to inclusion or current acute cholangitis or suspected cholangiocarcinoma.
- • Endoscopic treatment for bile duct stenosis ≤ 3 months prior to inclusion or planned within 3 months post randomization date
- • History of or established or suspected hepatobiliary carcinoma
- • Current or recent history (within 2 years) of clinically detectable Ascites or digestive hemorrhage
- • Any severe comorbidity that may reduce life expectancy
- • History of malignancy diagnosed or treated within 2 years (recent localized treatment of squamous or non-invasive basal skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to Screening)
- • Known hypersensitivity to bezafibrate, any of the components of Befizal© or other fibrates
- • Known photosensitivity or photoallergy reactions to fibrate
- • Patient with congenital galactosemia, glucose malabsorption, or lactase deficiency because of presence of lactose in 400 mg SR tablets of bezafibrate and in placebo tablets
- • Pregnancy (or desire for)
- • Renal insufficiency (clearance < 60 ml/min or serum creatinine level > 130 μmole/L)
- • Breastfeeding
- • Participation in any other interventional study or in the exclusion period any other interventional study
- • Total bilirubin in the last 3 months > 50 μmole/L (3 mg/dl)
- • Gilbert syndrome defined as unconjugated bilirubinemia > LSN in the last 3 months (according to the laboratory reference value)
- • Albumin in the last 3 months < LLN (according to the laboratory reference value)
- • Prothrombin index in the last 3 months < 70%
- • Platelets count in the last 3 months < 100000/mm3
- • ALT or AST > 5 ULN in the last 3 months
- • Prior liver transplantation
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.
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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.