NCT04376528Unknown4 期
Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Duo to Nonresponse to Standard Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Biochemical remission
研究概览
简要总结
Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by mycophenolate mofetil versus cyclosporin A
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-70 years;
- •Diagnosed with PBC-AIH overlap syndrome according to Paris criteria;
- •Patients have a nonresponse to azathioprine;
- •The WBC count ≥2.5x10^9/L and platelet count ≥50x10^9/L.
- •Agreed to participate in the trial, and assigned informed consent;
排除标准
- •The presence of hepatitis A, B, C, D, or E virus infection;
- •Patients with presence of serious decompensated cirrhosis;
- •Patients have a history of glucocorticoid or immunosuppressant medication before enrollment;
- •Liver damage caused by other reasons: such as primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson's disease.
- •Pregnant and breeding women and women of childbearing age in need of reproduction
- •Severe disorders of other vital organs, such as severe heart failure, cancer;
- •Patients with presence of renal insufficiency;
- •Parenteral administration of blood or blood products within 6 months before screening;
- •Recent treatment with drugs having known liver toxicity;
- •Taken part in other clinic trials within 6 months before enrollment.
- •Patients who are allergic to these drugs;
- •Uncontrolled infection and hypertension ;
研究组 & 干预措施
Cyclosporin A
Experimental
干预措施: Cyclosporin A (Drug)
Mycophenolate Mofetil
Active Comparator
干预措施: Mycophenolate Mofetil (Drug)
结局指标
主要结局
Biochemical remission
时间窗: up to 6 months
The percentage of patients in biochemical remission, defined as normalization of serum ALT and IgG levels after 24 weeks of treatment, per treatment group.
次要结局
- Partial remission(up to 6 months)
- Minimal response(up to 6 months)
- Treatment failure(up to 6 months)
- Changes in liver stiffness(up to 6 months)
- Side-effects(up to 6 months)
研究者
研究点 (1)
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