EUCTR2004-000558-22-ES进行中（未招募）1 期
Assessment of the Safety, Efficacy, Tolerability and Pharmacokinetics of PEG-Intron Plus REBETOL for Pediatric Patients with Chronic Hepatitis C
Schering-Plough Research Insitute0 个研究点目标入组 107 人开始时间: 2005年12月9日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 107
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
入选标准
- •-History of chronic hepatitis C as documented either by anti-HCV or HCV RNA
- •positivity at least 6 months prior to Screening 1.
- •-Subjects 3 through 17 years of age (inclusive) at time of Screening 2, of either
- •-Plasma positive for HCV RNA by quantitative RT-PCR, as measured by the
- •sponsor's assay, during Screening 1 visit.
- •-Results of a liver biopsy performed prior to entry to the study are required
- •(except as noted below):
- •Patients who have had a liver biopsy performed prior to consideration for
- •the study (historical liver biopsy) must have the pathology report confirming that the histological diagnosis is consistent with chronic hepatitis (evidence of fibrosis and/or
- •inflammatory activity) and slides from this biopsy must be available
- •for assessment by the study central pathologist
- •If no historical liver biopsy is available,
- •? All subjects with a history of transfusion-associated
- •chronic hepatitis C must have a pretreatment liver biopsy performed.
- •? Subjects 3-11 years old:
- •With a normal ALT level must have a pretreatment liver biopsy
- •With an elevated ALT level within 1 year prior to Screening 1 must
- •have a pretreatment liver biopsy requested of the subject/legal
- •guardian. If refused, the site should discuss the possible inclusion of
- •the subject into the study with the sponsor’s project physician.
- •? Subjects 12-17 years old must have a pretreatment liver biopsy
- •-Compensated liver disease with minimum hematologic, biochemical, and serologic criteria at the Screening 1 and 2 visits.
- •-Thyroid stimulating hormone (TSH), WNL.
- •-Antinuclear antibodies (ANA) =1:160 within 1 year of Screening 1 visit.
- •-Subjects with a history of mild depression and/or behavioral problems may be
- •considered for entry into this study provided that a pretreatment assessment
- •of the subject's affective status supports that the subject is clinically stable.
- •-All subjects must be willing to abstain from alcohol and any other illicit drugs
- •during the study.
- •-Reconfirmation and documentation that sexually active female and male subjects of childbearing potential are practicing adequate contraception.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •All subjects will be excluded from entry if any of the criteria listed below are
- •-Serum ALT level >10 times the upper limit of normal within the 6 months prior
- •to Screening 1 visit.
- •-Any other cause for liver disease other than chronic hepatitis C.
- •-Evidence of decompensated liver disease.
- •-The most recent liver biopsy is normal.
- •-Prior treatment for chronic hepatitis C.
- •-Known coinfection with either HIV or HBV.
- •-Known immunodeficiency disorders requiring immunoglobulin therapy.
- •-Known coagulopathies, including hemophilia, or anticoagulant use.
- •-Known hemoglobinopathies.
- •-Known G6PD deficiency.
- •-Evidence of active or suspected malignancy, or a history of malignancy within
- •the last 5 years.
- •-Subjects with organ transplants.
- •-Subjects with clinically significant retinal abnormalities such as known
- •retinopathy of prematurity or other retinopathies.
- •-Any known pre-existing medical condition that could interfere with the
- •subject's participation in and completion of the study.
- •-Subjects who have a history of pregnancy or who are pregnant and/or breast
- •feeding. Subjects who intend to become pregnant during the study period.
- •Subjects with partners who intend to become pregnant during the study
研究者
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