EUCTR2010-024260-17-CZ进行中（未招募）1 期
A Phase 3 Study to Assess the Efficacy and Safety of Boceprevir in Combination with Peginterferon alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1 - A Study in Pediatric Subjects with Hepatitis C to Study the Effects of Boc/ Peg/ Riba
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 190
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
- •1. Age =3 years and <18 years on the day of initiation of treatment (Day 1).
- •2. Weight =10 kg and =125 kg.
- •3. Body surface area (BSA) =0.46 m2 and =2.5 m2.
- •4. Each subject must have a liver biopsy with histology consistent with CHC and no other etiology within 2 years of the screening visit. If a previous liver biopsy is not available, the liver biopsy may be obtained during the screening period. The pathology report must be available at the study site.
- •5. Part A: Treatment naïve, non-cirrhotic pediatric subject with CHC genotype 1 (mixed genotypes are not eligible).
- •6. Part B: Pediatric subject with CHC genotype 1 (mixed genotypes are not eligible) who:
- •a) failed previous (peg)interferon/RBV treatment (null responder, partial responder, relapser, or other”) and is non-cirrhotic,
- •b) is cirrhotic regardless of whether treatment naïve or a treatment failure.
- •7. Part C: Subject must have completed the required post-treatment follow-up in Part A or Part B.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 190
- •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
- •1. Subject is known to be co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive).
- •2. Subject exhibits evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
- •3. Part A: Subject received any prior hepatitis C treatment, including herbal remedies with known hepatotoxicity but excluding study treatment received in the boceprevir pediatric Phase 1 single dose PK study (P07614).
- •4. Part B: Subject received treatment with RBV within 90 days or any (peg)interferon within 30 days prior to screening.
- •5. Part B: Subject received previous treatment with a HCV protease inhibitor but excluding study treatment received in the boceprevir pediatric Phase 1 single dose PK study (P07614).
- •6. Part B: Subject required discontinuation of previous (peg)interferon/RBV therapy for an AE considered by the investigator to be related to (peg)interferon and/or RBV.
- •7. Part B: Subject is currently taking any antiviral/immunomodulatory treatment for HCV but excluding study treatment received in the boceprevir pediatric Phase 1 single dose PK study (P07614).
- •KEY LABORATORY EXCLUSION CRITERIA:
- •1.Hemoglobin is not within normal limits of the laboratory reference range for the subject's age
- •2.Neutrophils <1500/mm3
- •3.Platelets <100,000/mm3
- •4.Direct bilirubin >1.5 x upper limit of normal (ULN) of the laboratory reference range. Total bilirubin >1.6 mg/dL, unless the subject has a history of Gilbert’s disease. If Gilbert’s disease is the proposed etiology, this must be documented.
- •5.Serum albumin 6. Thyroid-stimulating hormone (TSH) >1.2 x ULN or <0.8 x LLN of laboratory reference range with the following exceptions:
- •a. The subject may be enrolled if clinically euthyroid, b. The euthyroid function is confirmed by thyroxine (T4) testing.
- •7.Serum creatinine >ULN of laboratory reference range.
- •8. Serum glucose:
- •a. For subjects not previously diagnosed with non-insulin dependent diabetes: =140 mg/dL (nonfasting) unless hemoglobin A1c subtype (HbA1c) =7%.
- •b. For subjects previously diagnosed with non-insulin dependent diabetes: HbA1c >8.5%.
- •9.Prothrombin time (PT) values >10% above laboratory reference range.
- •10.Alpha fetoprotein (AFP) for subjects with cirrhosis only:
- •a. AFP >100 ng/mL OR
- •b. AFP is between 50 ng/mL to 100 ng/mL, a liver ultrasound is required. Subjects with findings suspicious for hepatocellular carcinoma will be excluded.
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