JPRN-UMIN000007704招募中3 期
Efficacy and Safety of Extended Triple Therapy, Peginterferon, Ribavirin and Telaprevir (Telavic) for Genotype1 and High Viral Load Chronic Hepatitis C Patients with IL28B Minor Allele - ESPRiT study
St. Mariaana University School of Medicine0 个研究点目标入组 140 人开始时间: 2012年4月9日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
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
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Patients with HBs antigen positive 2) Pregnant or lactating women, or women who may become pregnant 3) Patients with allergy to telaprevir 4) Patients with severe skin reactions when telaprevir administered 5) Patients with allergy to ribavirin and/or other nucleoside analogs 6) Patients with allergy to IFN 7) Patients with severe heart disease 8) Patients with hemoglobinopathy 9) Patients with contraindicated drugs as below (a)Antiarrhythmics Quinidine Sulfate Bepridil Hydrochloride Hydrate Flecainide Acetate Propafenone Hydrochloride Amiodarone Hydrochloride (b)Ergot derivatives Ergotamine tartrate Dihydroergotamine mesilate Ergometrine maleate Methylergometrine maleate (c)HMG-CoA reductase inhibitors Lovastatin Simbastatin Atorvastatin calcium hydrate (d)PDE5 inhibitors Vardenafil Hydrochloride Hydrate Sildenafil Citrate (for treatment of pulmonary arterial hypertension) Tadalafil (for treatment of pulmonary arterial hypertension) (e)Others Pimozide Triazolam Alfuzosin Blonanserin Colchicine (to patients with liver disorder and/or renal disorder) Rifampicin 10) Patients with renal failure and/or renal dysfunction (=>50mL/min.) 11) Patients with severe psychosis such as severe depression, suicidal ideation or attempt or with history of severe psychosis 12) Patients with autoimmune hepatitis 13) Patients receiving shosaiko-to 14) Patients with history of hypersensitivity to biological products 15) Patients taking other test drugs less than three months before treatment start 16) Patients who were not suitable for this trial judged by the attending doctor
研究者
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