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临床试验/NCT01770223
NCT01770223撤回4 期

An Open Label Study Assessing SVR and Viral Resistance Profile With Boceprevir Plus PEG-IFN Plus Ribavirin Triple Therapy in HCV-1 Infected Patients With Insulin Resistance Who Have Failed PEG-IFN Plus Ribavirin Dual Therapy

Merck Sharp & Dohme LLC0 个研究点开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
主要终点
Number of participants with sustained virologic response (SVR) at 24 weeks after the end of 48 weeks of study treatment

研究概览

简要总结

This study is being done to find out if participants with insulin resistance and hepatitis C virus genotype 1 (HCV GT1) infections who failed dual therapy with peginterferon alfa (PegIFN) + ribavirin (RBV) will benefit from the addition of boceprevir to PegIFN + RBV (triple therapy).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Boceprevir + PegIFN-2b + RBV

Experimental

All participants will start treatment with 4 weeks of PegIFN-2b subcutaneously, 1.5μg/kg per week + RBV capsules orally, at a weight-based dose between 800-1400 mg/day divided into two daily doses (double therapy). Participants without cirrhosis will then continue on the PegIFN-2b and RBV with the addition of boceprevir capsules orally, 800 mg three times per day for 32 weeks (triple therapy), and will transition back to double therapy for the final 12 weeks of treatment (48 total weeks of therapy). Participants with cirrhosis or documented as null responders will receive triple therapy for 44 weeks (48 total weeks of therapy).

干预措施: boceprevir (Drug)

Boceprevir + PegIFN-2b + RBV

Experimental

All participants will start treatment with 4 weeks of PegIFN-2b subcutaneously, 1.5μg/kg per week + RBV capsules orally, at a weight-based dose between 800-1400 mg/day divided into two daily doses (double therapy). Participants without cirrhosis will then continue on the PegIFN-2b and RBV with the addition of boceprevir capsules orally, 800 mg three times per day for 32 weeks (triple therapy), and will transition back to double therapy for the final 12 weeks of treatment (48 total weeks of therapy). Participants with cirrhosis or documented as null responders will receive triple therapy for 44 weeks (48 total weeks of therapy).

干预措施: PegIFN-2b (Biological)

Boceprevir + PegIFN-2b + RBV

Experimental

All participants will start treatment with 4 weeks of PegIFN-2b subcutaneously, 1.5μg/kg per week + RBV capsules orally, at a weight-based dose between 800-1400 mg/day divided into two daily doses (double therapy). Participants without cirrhosis will then continue on the PegIFN-2b and RBV with the addition of boceprevir capsules orally, 800 mg three times per day for 32 weeks (triple therapy), and will transition back to double therapy for the final 12 weeks of treatment (48 total weeks of therapy). Participants with cirrhosis or documented as null responders will receive triple therapy for 44 weeks (48 total weeks of therapy).

干预措施: RBV (Drug)

结局指标

主要结局

Number of participants with sustained virologic response (SVR) at 24 weeks after the end of 48 weeks of study treatment

时间窗: Week 72

次要结局

  • Change from baseline in Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR)(Baseline up to 8 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

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