EUCTR2012-000070-28-ES
进行中（未招募）
1 期
A Phase 2, Open-Label Study of Daclatasvir (BMS-790052) and TMC435 in Combination With or Without Ribavirin (RBV) For Treatment-Naive Subjects or Null Responders to Prior Peginterferon Alfa (PegIFN)/RBV Therapy with Genotype 1 Chronic Hepatitis C+Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, dated 14-May-12)
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Chronic Hepatitis C
- 发起方
- Bristol-Myers Squibb International Corporation
- 入组人数
- 230
- 状态
- 进行中（未招募）
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •? HCV Genotype 1a or 1b;
- •? Males and females, ? 18 years of age;
- •? HCV RNA \> 10,000 IU/mL;
- •? Subjects with compensated cirrhosis are permitted.
- •? Advanced fibrosis (F3/F4\) is capped at approximately 35% of the total treated population with a minimum of 20% F4 subjects.
- •? If no cirrhosis, a liver biopsy within 3 years prior to enrollment is required
- •? If cirrhosis is present, any prior liver biopsy is sufficient
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
排除标准
- •Target Disease Exceptions
- •? Liver or any other transplant (other than cornea and hair):
- •? Evidence of a medical condition contributing to chronic liver disease other than HCV;
- •? Current or known history of cancer, (except situ carcinoma or adequately tx basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
- •? Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy;
- •? Subjects infected with HIV or HBV;
- •? Gastrointestinal disease impacting absorption of study drug;
- •? Uncontrolled diabetes or hypertension;
- •Medication related
- •? Prior treatment of HCV with HCV direct acting agent (DAA);
结局指标
主要结局
未指定
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