NCT06591468Enrolling By Invitation2 期
A Multicenter, Randomized, Controlled Trial of Prednisone Combined With Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis With Moderate to Severe Interface Hepatitis Characteristics
Han Ying2 个研究点 分布在 1 个国家目标入组 244 人开始时间: 2024年10月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 244
- 试验地点
- 2
- 主要终点
- Percentage of patients with biochemical response
研究概览
简要总结
About 1/3 of patients with primary biliary cholangitis (PBC) exhibit moderate to severe interface hepatitis, and this group of patients have poor response to UDCA treatment. However, as it is not yet sufficient to diagnose autoimmune hepatitis or overlap syndrome, it is difficult to initiate immunosuppressive therapy such as steroids according to current guidelines. The aim of this study is to explore whether PBC patients with moderate to severe interfacial inflammation can benefit from UDCA combined with prednisone therapy, and its treatment safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily joining the group, able to understand and sign an informed consent form;
- •18 years old ≤ age ≤ 75 years old;
- •The diagnosis of primary biliary cholangitis follows the AASLD international diagnostic and treatment guidelines (meeting two of the following three criteria: AMA or gp210, sp100 positive; Elevated serum ALP levels; Pathological manifestations include non suppurative cholangitis and destruction of the interlobular bile duct;
- •Liver histology suggests moderate to severe interfacial hepatitis (moderate,<50% portal or fibrous septa destruction, severe,>50% portal or fibrous septa destruction) with serum ALT<5 * ULN, serum IgG<2 * ULN, and negative serum anti smooth muscle antibodies;
- •Not receiving UDCA, hormone or other immunosuppressive therapy before enrollment;
- •ALP>1.67 * ULN.
排除标准
- •History or presence of other concomitant liver diseases.
- •ALT or AST > 5×ULN, TBIL > 3×ULN.
- •If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.
- •Allergic to fenofibrate or ursodeoxycholic acid.
- •Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users.
- •Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites.
- •Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse).
- •Creatinine >1.5×ULN and creatinine clearance <60 ml/min.
- •Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen).
- •Planned to receive an organ transplant or an organ transplant recipient.
- •Needing Liver transplantation within 1 year according to the Mayo Rick score.
- •Any other condition(s) that would compromise the safety of the subject or compromise
研究组 & 干预措施
UDCA
Active Comparator
UDCA (13-15 mg/kg/day)
干预措施: UDCA (Ursodeoxycholic acid) (Drug)
结局指标
主要结局
Percentage of patients with biochemical response
时间窗: 1 year
Alkaline Phosphatase \< 1.67\*ULN
次要结局
- Assessment of the pruritus and fatigue(1, 3, 6, 9, and 12 months)
- Survival without transplantation and hepatic impairment(1 year)
研究者
Han Ying
Professor
Xijing Hospital of Digestive Diseases
研究点 (2)
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