EUCTR2010-023498-20-DE进行中（未招募）不适用
Assessment of the Pharmacokinetics of Boceprevir in Pediatric Subjects with Chronic Hepatitis C Genotype 1 (Phase 1b)
Merck Sharp & Dohme Corp., a subsidiary of Merck and Co., Inc.0 个研究点目标入组 48 人开始时间: 2012年7月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Key Inclusion Criteria:
- •1) Subjects must be 17 to 3 years of age (inclusive) at screening.
- •2) Subjects must have previously documented CHC genotype 1 infection. Subjects with other or mixed genotypes are not eligible. The HCV-RNA result at the Screening visit must confirm genotype 1 infection.
- •3) Subjects may be treatment naïve or have failed previous (peg)interferon/ribavirin treatment, and may be cirrhotic or non-cirrhotic
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 48
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Key Clinical Exclusion Criteria:
- •1) Subjects known to be co-infected with the human immunodeficiency virus (HIV) and hepatitis B virus (HBaAg positive).
- •2) Subjects must not have received treatment with RBV within 90 days or any interferon-alpha within 30 days prior to screening, or currently be receiving antiviral/immunomodulatory treatment for hepatitis C.
- •3) Subjects must not have received previous treatment with a HCV protease inhibitor.
- •Key Laboratory Exclusion Criteria
- •Hematologic criteria (growth factors may not be used to achieve study entry requirements):
- •o Hemoglobin < lower limit of normal range (LLN)
- •o Neutrophils <1500/mm3
- •o Platelets <100,000/mm3
- •Serum albumin < lower limit of normal (LLN) of laboratory reference range.
- •Thyroid-stimulating hormone (TSH) >1.2 x ULN or <0.8 x LLN of laboratory reference range with the following exceptions:
- •o The subject may be enrolled if clinically euthyroid, AND
- •o The euthyroid function is confirmed by thyroxine/triiodothyronine (T4/T3) testing
- •Serum creatinine > ULN of laboratory reference range
研究者
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