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临床试验/NCT05392673
NCT05392673已完成不适用

Comparative Analysis on Short-term Efficacies of Two Kinds of Artificai Liver Method in Treating Severe Hepatitis B.

Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
186
试验地点
1
主要终点
Number of Participants with death

研究概览

简要总结

This was a non-blinded, prospective clinical study. From June 2020 to October 2021, 254 patients with HBV-ACLF were treated at the Department of Infectious Diseases, Xiangya Hospital, Central South University (Changsha, China). 186 patients who met the enrollment criteria were included in this study. Inclusion criteria were as follows: (1) aged 18-65 years old; (2) patients with ACLF caused by HBV infection; (3) meeting the diagnostic criteria for ACLF by the Asian Pacific Association for the Study of Liver (APASL).The exclusion criteria were as follows: (1) pregnancy or lactation; (2) previous liver transplantation; (3) hepatocellular carcinoma or other malignancy; (4) human immunodeficiency virus(HIV) infection or other immunocompromised states; (5) complicated with underlying diseases such as severe heart, respiratory, and blood system diseases. Based on the inclusion and exclusion criteria, the investigators randomly matched patients at a 1:1:1 ratio to three groups whose age, sex ratio, complication, and liver function were comparable: comprehensive medical treatment (Control group), PE group, and DPMAS plus half-dose sequential PE (DPMAS + PE group). As a result, 62 subjects per group were recruited into the study. This study was approved by the Clinical Research Ethics Committee of Xiangya Hospital, Central South University with informed content obtained from all participants (No. 202201022). The study protocol followed the principles of the Helsinki Declaration strictly.

All the 186 patients enrolled received comprehensive medical treatment after admission to the hospital, including anti-viral treatment, general supportive treatment, supplementation of blood products, such as albumin and plasma, and symptomatic treatment.

研究设计

研究类型
Interventional
分配方式
Non 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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged 18-65 years old
  • patients with ACLF caused by HBV infection
  • meeting the diagnostic criteria for ACLF by the Asian Pacific Association for the Study of Liver.

排除标准

  • pregnancy or lactation
  • previous liver transplantation
  • hepatocellular carcinoma or other malignancy
  • human immunodeficiency virus(HIV) infection or other immunocompromised state
  • complicated with underlying diseases such as severe heart, respiratory, and blood system diseases

结局指标

主要结局

Number of Participants with death

时间窗: 90 days

Number of Participants with Liver transplantation

时间窗: 90 days

Number of Participants with survival without liver transplantation

时间窗: 90 days

次要结局

  • Progress of biochemical indexes(90 days)

研究者

发起方
Xiangya Hospital of Central South University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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