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临床试验/NCT03979417
NCT03979417已完成不适用

Identification of Biomarkers Related to Liver Fibrosis as New Therapeutic Targets

Institut Pasteur2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2019年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Identification of biomarkers of liver fibrosis

研究概览

简要总结

Fibrosis is a dynamic process resulting from the balance of fibrogenesis and fibrolysis, mainly secondary to chronic necro-inflammation related to regular alcohol consumption, metabolic syndrome (NASH) or viral hepatitis. The liver has the property of allowing the reversion of fibrosis / cirrhosis when the necrotic-inflammatory activity is controlled. The balance between fibrosis / fibrolysis and its inhibition depends on many pathways and the hypothesis of the efficacy of a single treatment remains uncertain. Molecular factors in the progression of liver fibrosis should be determined. It is necessary to control the liver fibrosis and thus reduce the risk of carcinoma in this population. The anti-fibrotic drugs are being developed, but so far only alpha-tocopherol and obeticholic acid have been shown to have a significant anti-fibrotic effect in humans. Several new drugs are currently being evaluated in ongoing Phase 2 and 3 randomized clinical trials, but most of them have intrinsic limitations: (i) they take a long time for evaluation (> 3 years), ( ii) they generally require an histopathological evaluation by serial liver biopsies that are invasive and unpopular with patients who are aware of noninvasive tests for fibrosis assessment and (iii) treatment is often a single treatment versus a placebo group with the uncertainty that at 1 or 3 years, serial liver biopsies results are convincing.

详细描述

The study will be performed in 30 patients. Patients will be enrolled in two investigators sites (Cochin Hospital, Pitie-Salpetriere Hospital, France) where the patient selection will be conducted during a Multidisciplinary Collaborative Meeting.

The patients will be enrolled after collecting their informed consent. As soon as the patient is included, arrangements will be made for the organization of the liver resection according to the usual procedure of the hospital department.

The biological samples for the research (blood and liver) will be taken at the time of the surgery and sent to the Research Unit (Institut Pasteur) where immunological analyses will be carried out.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients > 18 years
  • Patients with primary liver disease or liver metastases
  • Patients undergoing liver resection

排除标准

  • Presence of Human Immunodeficiency Virus (HIV) infection
  • Presence of Human T Leukemia Virus (HTLV) infection
  • Taking immunosuppressive drugs in the 6 months prior to surgery
  • A person deprived of liberty by judicial or administrative decision

结局指标

主要结局

Identification of biomarkers of liver fibrosis

时间窗: Baseline

Frequency of cell receptors (CD4, CD8, NK, MAIT, etc.) in whole blood and liver (measured by FACS). A comparison will be made in each of the 3 groups (F0-F1, F2-F3, F4) and between the three groups.

次要结局

  • Evaluation of anti-fibrotic properties of biomarkers(Baseline)
  • Transcription factors(Baseline)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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