EUCTR2010-023498-20-GB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) - PO7614 PK of Boceprevir in CHC Paediatric Patients
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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
- •1. Subjects and/or legal guardian must provide written informed consent for the trial. 2. Subjects must be able to adhere to dose and visit schedules. 3. Subjects must have chronic Hepatitis C genotype 1 infection. 4. Pediatric subject with CHC genotype 1 who a) is treatment naive, OR b) failed previous (peg)interferon/Ribavirin treatment (e.g. null responder, partical responder, or relapser) 5. Subjects may be cirrhotic or non-cirrhotic 6. Subject who is a treatment failure must have completed at least 12 weeks of uninterrupted therapy with (peg)interferon/Ribavirin 7. Male and female subjects must be between the ages of 17 and 3 years (inclusive) and have a body mass index of between 18 and 32, inclusive. 8. Subjects must weigh between 10 kg and 90 kg at screening and baseline. 9. Vital sign measurements must be within an acceptable range. 10. Female subjects of childbearing potential, who are not surgically sterilized, must be willing to use medically accepted method(s) of contraception for 3 months prior to the screening period, during the screening and study period and for 2 months after stopping the trial medication or abstain from sexual intercourse. Nonvasectomized men must agree to use a condom with spermicide or abstain from sexual intercourse during the trial and for 3 months after stopping study medication.
- •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 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •A subject meeting any of the following exclusion criteria is not eligible to participate in the study. 1. Subject is coinfected with HIV or Hepatitis B virus. 2. Subject received any prior hepatitis C treatment with known hepatotoxicy including herbal remedies with known hepatotoxicity. 3. Subject received treatment with ribavirin within 90 days or any interferon-alpha within 30 days prior to screening. 4. Subject received previous treatment with a HCV protease inhibitor. 5. Subject required discontinuation of previous (peg)interferon/ribavirin therapy for an AE considered by the investigator to be related to (peg)interferon and/or ribavirin. 6. Subject is currently taking any antiviral/immunomodulatory treatment for hepatitis C. 7. The subject has used any investigational drugs within 30 days of enrolment into this study. 8. The subject is participating in a clinical trial within 30 days of enrolment or is planning to participate in another clinical trial during participation in this study. 9. Subject has evidence of decompensated liver disease. 10. The subject has a history of diabetes, hypertension or birth prior to 32 weeks gestation with clinically significant ocular examination findings or any other clinically significant preexisting medical condition that would affect participation in the study. 11. Preexisting clinically significant psychiatric conditions or personality disorders that in the opinion of the Investigator and Sponsor, affects the subject's ability to participate in the trial. 12. Substance abuse any time prior to entry into the study. 13. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug or interfer with the subject's participation and completion of the study. 14. Subject has a history of infectious disease within 4 weeks prior to drug administration that will affect participation in the study. 15. Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin). 16. The female subject is pregnant or breastfeeding. The female subject intends to become pregnant during or 3 months after the ending of the study or the male subjects intends to father a child during or 3 months after the ending of the study. 17. The subject had a lifethreateningserious adverse event during the screening period. Key Clinical Laboratory Criteria: 1. Haematologic criteria (growth factors may not be used to achieve study entry requirements): o Haemoglobin < lower limit of normal range (LLN) o Neutrophils <1500/mm3 o Platelets <100,000/mm3 2. Serum albumin < lower limit of normal (LLN) of laboratory reference range. 3. Serum creatinine > ULN of laboratory reference range 4. Thyroidstimulating hormone (TSH) >1.2 x ULN or <0.8 x LLN of laboratory reference range with the following exceptions: o The subject may be enroled if clinically euthyroid, AND o The euthyroid function is confirmed by thyroxine/triiodothyronine (T4/T3) testing
研究者
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终止
1 期
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