NCT06371196尚未招募4 期
Clinical Study on the Treatment of Elevated Total Bilirubin in Primary Biliary Cholangitis With Baobao Dan Capsule
Mei Han0 个研究点目标入组 60 人开始时间: 2024年4月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Total bilirubin (TBil) reversion rate
研究概览
简要总结
- Explore the effect of Babaodan Capsule on the serum total bilirubin level of primary biliary cholangitis patients with elevated total serum bilirubin;
- To observe the positive intervention effect of Babaodan Capsule on the clinical symptoms of primary biliary cholangitis patients with elevated total bilirubin.
详细描述
- Primary objective: to investigate the effect of Baobao Dan capsule on serum total bilirubin levels in patients with primary biliary cholangitis with elevated total serum bilirubin.
- Secondary objective: to observe the effects of Babaodan Capsule on the following aspects in patients with primary biliary cholangitis with elevated total bilirubin:
(1) Other indicators of liver function: ALP, GGT, AST, ALT, TBA, TBil, DBil, IBil; (2) Itching and fatigue symptom scores; (3) Biochemical response rate; (4) Histologic changes; (5) Changes in immunologic indices (serum IgM, IgG, IgA, autoantibodies AMA/AMA-M2 and anti-gp210 antibody, anti-sp100 antibody); (6) Adverse events and safety evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •meets the diagnostic criteria for primary biliary cholangitis (PBC) in the Diagnostic and Therapeutic Guidelines for Primary Biliary Cholangitis (2021), i.e., meets at least 2 out of the following 3 criteria: (i) Biochemical evidence of cholestasis, i.e., elevated ALP and GGT, and imaging studies that exclude extrahepatic or intrahepatic biliary obstruction; (ii) Anti-mitochondrial antibody (AMA) or AMA-M2 positivity or, if AMA negative, PBC-specific antibody (anti-GP210 and/or anti-SP100) positivity; (iii) Histologic evidence suggestive of non-purulent destructive cholangitis and interlobular bile duct destruction.
- •Male or female, ≥ 18 years of age and < 75 years of age;
- •ursodeoxycholic acid capsule (Yusuf) 10 ~15 mg/d for ≥6 months prior to screening and after screening enrollment, the therapeutic dose was maintained unchanged for the duration of the trial;
- •ALP ≥ 1.67 x ULN;
- •liver function tests no less than 2 times in the last 3 months, and total bilirubin in liver function tests before enrollment and in the last 3 months are in accordance with the following: 1 × ULN < TBil ≤ 5 × ULN;
- •Understand the content of the study, be willing to comply with the study protocol, and voluntarily sign the written informed consent.
- •Exclusion Criteria.
- •Combination of or history of other liver diseases, including: (1) hepatitis C virus (HCV) infection; (2) hepatitis B virus (HBV) infection; (3) primary sclerosing cholangitis (PSC); (4) alcoholic liver disease; (5) autoimmune hepatitis (AIH) or overlapping autoimmune liver disease; (6) nonalcoholic steatohepatitis (NASH); (7) drug-induced liver injury; (8) extrahepatic biliary obstruction; (9) Gilbert's syndrome; (10) suspected or diagnosed primary liver cancer; (11) suspected or confirmed primary liver cancer; and (12) extrahepatic biliary obstruction; ⑨ Gilbert's syndrome; ⑩ suspected or confirmed primary liver cancer;
- •Presence of clinical complications of PBC, including but not limited to: (i) history of liver transplantation, pending liver transplantation, or current Model for End-Stage Liver Disease (MELD) score ≥ 15; (ii) portal hypertension with complications, including gastric or large esophageal varices, refractory or diuretic-resistant ascites, history of variceal hemorrhage, history of variceal treatment such as use of β-blockers, endoscopic tissue adhesive injections or ligatures, transjugular portacaval shunts, or hepatic encephalopathy; (iii) cirrhosis with Complications, including spontaneous bacterial peritonitis, hepatocellular carcinoma;
- •Hepatorenal syndrome (type I or II) or screening serum creatinine (Cr) ≥ 1.5 x ULN and serum creatinine clearance < 60 mL/min;
- •Hepatic function Child-Pugh classification grade B/C;
- •ALT ≥ 5 × ULN and/or AST ≥ 5 × ULN;
- •ALP > 10 × ULN;
- •patients with pruritus with severe itching or requiring systemic medication (e.g., bile acid sequestrants or rifampicin, etc.) within 2 months prior to enrollment
- •use of the following medications within 3 months prior to enrollment: azathioprine, colchicine, cyclosporine, methotrexate, mycophenolate mofetil, hexacosanol, dicyclomine, simethicone, ximethicone; fenofibrate or other fibrates; budesonide and other systemic corticosteroids; and hepatotoxic medications (including alpha-methyldopa, valproate, isoniazid, furosemide, etc.);
- •use of the following medications within 12 months prior to enrollment and throughout the trial: antibodies or immunotherapies against interleukins or other cytokines or chemokines;
- •having or having had a previous cardiac arrhythmia requiring clinical intervention that may affect survival during the trial; or pre-treatment QT prolongation or QTc intervals ≥470ms in men and ≥480ms in women
- •pregnant, planning pregnancy, breastfeeding women, women of childbearing potential who do not wish to use effective contraception (≥1 effective method of contraception e.g., condom, hormonal contraceptive pill, intrauterine device), or male subjects who do not wish to use contraception during the trial period and up to 30 days after the last dose of study medication
- •patients with co-infections of infectious diseases such as HIV, syphilis, and neo-coronavirus;
- •the presence of any other disease or condition that interferes with the absorption, distribution, metabolism, or excretion of the drug (e.g., patients with inflammatory bowel disease or those who have undergone gastric bypass surgery);
- •any other disease that is not well controlled or for which the need for the drug is expected to change during the trial;
- •persons with a suspected or confirmed history of alcohol or drug abuse within 1 year prior to screening;
- •incapacitated or restricted persons;
- •subjects who have been enrolled in another study within 30 days prior to Screening
- •mentally unstable or incapacitated persons for whom the validity of informed consent or compliance with the trial is uncertain;
- •has had a malignant tumor in the last 5 years, with or without treatment and with or without evidence of local recurrence or metastasis;
- •the patient has taken Babao Dan capsule within 1 month prior to the trial;
- •who, in the opinion of the investigator, should not participate in the trial.
排除标准
- 未提供
研究组 & 干预措施
Babaodan Capsule
Experimental
Babaodan Capsule (State Drug License: Z10940006) is manufactured by Xiamen Traditional Chinese Medicine Factory Co., Ltd; Packing specification: 0.3g/capsule, 6 capsules/board×2 boards/carton; Ingredients are in vitro cultivated cowhide, snake gallbladder, antelope horn, pearl, panax ginseng, artificial musk and so on.
干预措施: Babaodan Capsule (Drug)
结局指标
主要结局
Total bilirubin (TBil) reversion rate
时间窗: 90 days
Total bilirubin (TBil) reversion rate: cases with normal total bilirubin index after treatment/60 cases × 100%
Total bilirubin (TBil) efficacy rate
时间窗: 90 days
Total bilirubin (TBil) efficacy rate: total bilirubin index decreased by 1×ULN cases/60 cases×100% after treatment compared with before treatment.
次要结局
- ALT(90 days)
- biological response rate(90 days)
- AST(90 days)
- ALP(90 days)
- DBil(baseline, 30 days, 60 days, 90 days)
- Immunological indicators - anti-sp100 antibody(90 days)
- TBA(90 days)
- 5-D Pruritus Scale Score(90 days)
- Immunological indicators - serum IgM(90 days)
- Immunological indicators - autoantibodies AMA/AMA-M2(90 days)
- Histopathology of the liver - grading of inflammatory activity(Changes of 90 days from the baseline.)
- Histopathology of the liver - staging of the degree of fibrosis(Changes of 90 days from the baseline.)
- IBil(90 days)
- Fatigue section of the PBC-40 questionnaire(90 days)
- Coagulation tests-PT(baseline, 30 days, 60 days, 90 days)
- Coagulation tests-APTT(baseline, 30 days, 60 days, 90 days)
- Coagulation tests-TT(baseline, 30 days, 60 days, 90 days)
- Coagulation tests-FIB(baseline, 30 days, 60 days, 90 days)
- Urine beta-hCG pregnancy test(baseline, 30 days, 60 days, 90 days)
- adverse event(baseline, 30 days, 60 days, 90 days, 100 days)
- Body temperature(baseline, 30 days, 60 days, 90 days)
- Heart rate(baseline, 30 days, 60 days, 90 days)
- Number of breaths in 1 min(baseline, 30 days, 60 days, 90 days)
- Blood pressure-Diastolic blood pressure(mmHg)(baseline, 30 days, 60 days, 90 days)
- Blood pressure-Systolic blood pressure(mmHg)(baseline, 30 days, 60 days, 90 days)
- Immunological indicators - serum IgG(90 days)
- Immunological indicators - serum IgA(90 days)
- Immunological indicators - anti-gp210 antibody(90 days)
- 12-lead electrocardiogram(baseline, 30 days, 60 days, 90 days)
- Physical examination(baseline, 30 days, 60 days, 90 days)
- Routine blood test(baseline, 30 days, 60 days, 90 days)
- Renal Function Tests-BUN(baseline, 30 days, 60 days, 90 days)
- Renal Function Tests-UA(baseline, 30 days, 60 days, 90 days)
- Renal Function Tests-Scr(baseline, 30 days, 60 days, 90 days)
- Urinalysis(baseline, 30 days, 60 days, 90 days)
研究者
Mei Han
Principal Investigator
Beijing University of Chinese Medicine
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