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临床试验/NCT01726400
NCT01726400已完成不适用

Is Hepcidin a Possible Contributor to Impaired Iron Mobilization and Anaemia in Hepatitis C Patients Treated With Pegylated Interferon Alpha and Ribavirin Therapy? A Pilot Study

Fremantle Hospital and Health Service1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2012年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
Hepcidin levels

研究概览

简要总结

The standard treatment of chronic hepatitis C infection is pegylated interferon alpha combined with ribavirin. Anaemia is a common complication occurring in up to 30% of subjects. Unfortunately, side effects of interferon and ribavirin therapy can require dose reductions, reducing the likelihood of sustained viral response. Recent data shows that interferon alpha may increase hepcidin (a key iron regulator) production, resulting in impaired iron availability for production of red blood cells. In this study, we will evaluate hepcidin levels in 30 patients with Hepatitis C who are treated with interferon containing regimes. If hepcidin plays a role in interferon-induced anaemia, cheap and readily available oral hepcidin inhibitors could be trialled to potentially reduce the impact of interferon alpha induced anaemia.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any patient with hepatitis C eligible for treatment with pegylated interferon alpha containing regimes.

排除标准

  • less than 18 years of age

研究组 & 干预措施

Interferon and ribavirin

Treatment with standard of care pegylated interferon alpha and ribavirin.

干预措施: Pegylated interferon alpha (Drug)

Interferon and ribavirin

Treatment with standard of care pegylated interferon alpha and ribavirin.

干预措施: Ribavirin (Drug)

结局指标

主要结局

Hepcidin levels

时间窗: Measured at -2 weeks, start of treatment and week 3,4,8, 12 and 24.

To measure changes in serum hepcidin levels during pegylated interferon alpha and ribavirin therapy in subjects with chronic hepatitis C infection.

次要结局

  • erythropoiesis markers(Measured at -2 weeks, start of treatment and week 3,4,8, 12 and 24.)
  • heamolysis markers(Measured at -2 weeks, start of treatment and week 3,4,8, 12 and 24.)
  • inosine triphosphatase genetic variants(Baseline)
  • iron metabolism markers(Measured at -2 weeks, start of treatment and week 3,4,8, 12 and 24.)

研究者

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

Dr Marius van Rijnsoever

Medical Registrar

Fremantle Hospital and Health Service

研究点 (1)

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