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临床试验/CTRI/2011/091/000028
CTRI/2011/091/000028已完成4 期

Efficacy and safety of PEG-Inferon (peginterferon alpha-2b) for the treatment of chronic hepatitis C

Virchow Biotech0 个研究点目标入组 100 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1.Adult male or female between 18-65 years (both years inclusive).
  • 2.Patients with chronic hepatitis C infection.
  • 3.Presence of serum alanine aminotransferase (ALT) levels 1.5 times greater than normal (N <40 IU/litre).
  • 4.Compensated liver disease at the time of baseline visit as defined by Child-Pugh class A.
  • 5.Hemoglobin greater than or equal to 9 g/dL (females),greater than or equal to 10 g/dL (males); platelet count greater than or equal to75 Ã? 109/L; neutrophil count greater than or equal to1.5 Ã? 109/L; thyroid stimulating hormone (TSH) within normal limits (0.35 - 5.50 µIU/mL).
  • 6.Willing to give written informed consent and adhere to study visit schedule.

排除标准

  • 1.Any evidence of other liver diseases HAV, HBV, HDV, alpha 2 anti-trypsin deficiency, Wilson?s disease, primary biliary cirrhosis, alcoholic liver disease or autoimmune liver disease, hemochromatosis.
  • 2.A chronic alcoholic or drug abuse problem or severe psychiatric condition.
  • 3.Pregnant or intent to be pregnant during the study period or nursing mothers.
  • 4.Patients with immune suppression associated with organ transplantation especially liver transplantation.
  • 5.History of hypersensitivity to interferon or its diluents. Significant psychiatric disease especially depression.
  • 6.Severe cardiovascular disease.
  • 7.Patients with human immunodeficiency virus (HIV) infection.

研究者

发起方
Virchow Biotech

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