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临床试验/NCT02714712
NCT02714712已完成不适用

Influence of Scavenger Receptor Class B Type I (SR-BI) Gene Polymorphisms on Antiviral Treatment Response, and Metabolism in Chronic Hepatitis C Patients

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation0 个研究点目标入组 309 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
309
主要终点
Serum HCV RNA levels

研究概览

简要总结

The scavenger receptor type B class I (SR-BI) is a receptor for high-density lipoproteins (HDL) and one of entry factors for hepatitis C virus (HCV). The investigators aimed to examine the association of single nucleotide polymorphisms (SNPs) of the SCARB1 gene, which encodes SR-BI, with virologic responses to pegylated interferon-based treatment in Asian chronic hepatitis C (CHC) patients.

详细描述

  1. Purpose of study: To examine the impacts of single nucleotide polymorphisms (SNPs) relevant to SR-BI on CHC patients.
  2. Study Design To enroll 400 CHC patients during a 3-year period
  3. Specify objectives of study when collecting extra specimen from participants Collect blood samples for genomic DNA to examine the SR-BI gene polymorphisms.
  4. Expected Endpoints of Treatment Sustained virologic response (SVR) means undetectable serum HCV RNA levels 24 weeks after completion of antiviral therapy.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Naive to IFN treatment and other experimental antiviral or immunosuppressive therapy before enrollment.
  • Serum alanine aminotransferase levels, at least, twice the upper limit of normal on two occasions within the previous 6 months.

排除标准

  • Positive for hepatitis B surface antigen
  • Positive for human immunodeficiency virus antibody
  • Had a known history or evidence of autoimmune liver disease, inheritable disorders, renal insufficiency, malignancy
  • Had a history of daily alcohol consumption greater than 20 gram or active drug abuse.

研究组 & 干预措施

HCV group (Peginterferon alfa-2a)

A total of 156 chronic HCV genotype 1 or 2 patients who received Peginterferon alfa-2a (Peg-IFN alfa-2a) plus ribavirin therapy were consecutively enrolled from the gastroenterological clinics.

干预措施: Peginterferon alfa-2a (Drug)

结局指标

主要结局

Serum HCV RNA levels

时间窗: at 24 weeks after the end of treatment

sustained virologic response

次要结局

  • serum fasting blood glucose levels(at 24 weeks after the end of treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ching-Sheng Hsu

Attending physician

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

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SR-BI and Antiviral Treatment Response in HCV | 临床试验