跳至主要内容
临床试验/NCT00487318
NCT00487318已完成2 期

A Randomized Controlled Trial of Adding Fluvastatin to Standard Medical Treatment (SMT) and a Pilot Trial of Rosuvastatin and Other Statins With SMT, for Patients Infected With Chronic Hepatitis C Who Are Naive to Therapy.

Bader, Ted, M.D.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2007年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Sustained Viral response

研究概览

简要总结

Hypothesis: addition of fluvastatin will increase the cure rate of standard anti-HCV therapy. Summary: This trial is limited to veterans in Oklahoma who qualify for care with the Veterans Administration. It is a randomized control format including genotypes 1 and 3. There will also be pilot arms for HCV carriers who present for screening already on a statin, who will be allowed to stay on their current statin or switched to another statin. In all ways, standard therapy as noted on pegylated interferon and ribavirin will be given per FDA package insert.

研究设计

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

入选标准

  • Not previously treated.
  • Off alcohol and marijuana for 6 months
  • HCV RNA positive

排除标准

  • HIV positive
  • Advanced liver disease
  • Advanced cardiopulmonary disease
  • Chronic renal failure

研究组 & 干预措施

Arm 1 Plus statin

Experimental

The addition of fluvastatin or rosuvastatin or other statins to the standard of care of peginterferon and ribavirin.

干预措施: fluvastatin (Drug)

2

Active Comparator

Administration of the standard of care for hepatitis C of peginterferon and ribavirin.

干预措施: standard of care (Drug)

结局指标

主要结局

Sustained Viral response

时间窗: 72 weeks

次要结局

  • Viral load at 4, 12 and 24 weeks(24 weeks)

研究者

发起方
Bader, Ted, M.D.
申办方类型
Indiv
责任方
Principal Investigator
主要研究者

Ted Bader, MD

Director of Liver Diseases, VA Medical Center

Bader, Ted, M.D.

研究点 (1)

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