2023-504086-23-00招募中3 期
Efficacy and safety of bezafibrate 400 mg and bezafibrate 200 mg as adjunctive treatments in patients with primary biliary cholangitis and non-optimal biochemical response to ursodeoxycholic acid therapy: a 12-month, double-blind, randomized, placebo-controlled trial with a 12-month, double-blind, placebo-free extension phase - BEZURSO 2
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 30
- 主要终点
- • Proportion of patients with a complete biochemical response defined by normal serum levels of alkaline phosphatase (ALP), gamma-glutamyl transpeptidase (GGT), aminotransferases (AST, ALT), and total bilirubin at 48 weeks of treatment.
研究概览
简要总结
To assess the effect of bezafibrate 200 mg and bezafibrate 400 mg versus placebo as adjunctive treatments in patients with PBC and a non-optimal response to UDCA.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and < 80 years
- •Signed informed consent
- •Diagnosis of PBC based on at least 2 of the following criteria (EASL clinical practice guidelines 2017:
- •a. Elevated ALP level
- •b. Presence of antimitochondrial antibody (immunofluorescence titer ≥ 1:40 or positive antigen-specific test), specific antinuclear immunofluorescence (nuclear dots or perinuclear rims) or positive antigen-specific test for anti-gp210 or anti-Sp100 antibodies
- •c. Records of histologic features suggestive of, or compatible with PBC
- •UDCA therapy for the past 12 months (stable dose ≥ 12 mg/kg/d for ≥ 3 months prior to inclusion)
- •Biochemical evidence of non-optimal response to UCDA (i.e. ALP > 1.0 xULN, or GGT > 3.0 xULN, or ALT or AST > 1.0 xULN, or total and conjugated bilirubin > 1.0 xULN) between 3 months and 2 weeks before inclusion visit. If total bilirubin is within the normal range, measurement of conjugated bilirubin is not mandatory.
- •Women of child-bearing potential (WOCBP), 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, throughout the study period and for 90 days following the last dose of study treatment. *the list of acceptable method of contraception is in addenda 18.1
- •Affiliation to a social security system (AME excepted)
排除标准
- •Any of the following signs of advanced chronic liver disease: Total bilirubin > 2.0 xULN; Serum albumin < 32 g/l; Platelet count < 100,000/mm3; INR > 1.3 or prothrombin index < 60%; Child-Pugh score B or C; MELD score ≥ 14; History ≤ 24 months or presence of cirrhotic decompensation; Patients on the waiting list for LT
- •Gilbert’s syndrome or chronic hemolysis (hyperbilirubinemia with an unconjugated to total bilirubin ratio ≥ 75%)
- •History of or established or suspected hepatocellular carcinoma
- •History of malignancy diagnosed or treated within 2
- •Any severe comorbidity that may reduce life expectancy ≤ 2 years
- •Pregnancy or lactating
- •Known intolerance to bezafibrate
- •Known hypersensitivity to bezafibrate, any of the components of Befizal© or other fibrates
- •Known photosensitivity reactions or photoallergic reactions to fibrates
- •Patient with congenital galactosemia, glucose malabsorption, or lactase deficiency because of presence of lactose in LP tablets of bezafibrate
- •Participation in any other interventional study in the past 6 months (RIPH1, clinical investigation or clinical trial)
- •GFR estimated by CKI-EPI equation < 60 mL/min
- •Any of the following medications used in the past 3 months before inclusion: bezafibrate, fenofibrate, ciprofibrate, gemfibrozil, obeticholic acid, budesonide, any other systemic corticosteroids, azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus, everolimus, methotrexate.
- •Use of statins in the month before inclusion
- •CPK > 5.0 xULN
- •AST or ALT > 3.0 xULN
- •History of LT
- •Features of autoimmune hepatitis (AIH) overlap syndrome (either past or newly diagnosed during follow up)
- •Any other chronic hepatic comorbidities (HIV, HCV, HBV, NASH, alcoholic liver disease, hemochromatosis, Wilson's disease, α1-antitrypsin deficiency, celiac disease)
- •Untreated hypo or hyperthyroidism (Hashimoto or Graves autoimmune thyroiditis)
- •Conditions that may cause non-hepatic increases in ALP (Paget’s disease, osteodystrophy, hyperparathyroidism, dysglobulinemia)
结局指标
主要结局
• Proportion of patients with a complete biochemical response defined by normal serum levels of alkaline phosphatase (ALP), gamma-glutamyl transpeptidase (GGT), aminotransferases (AST, ALT), and total bilirubin at 48 weeks of treatment.
• Proportion of patients with a complete biochemical response defined by normal serum levels of alkaline phosphatase (ALP), gamma-glutamyl transpeptidase (GGT), aminotransferases (AST, ALT), and total bilirubin at 48 weeks of treatment.
次要结局
- 1. Changes from baseline to W48 in itch intensity mean of the last 24h assessed by NRS as recommended by IFSI SIG / EADV Task Force Pruritus.
- 2. Proportion of patients with normal levels of ALP at W48.
- 3. Changes from baseline to W48 in LSM assessed by Fibroscan.
研究者
Christophe CORPECHOT
Scientific
Assistance Publique Hopitaux De Paris
研究点 (30)
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