NCT01590225撤回3 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Participants Achieving SVR at Follow-Up Week 24 in Study Part B
研究概览
简要总结
This is a three-part (Part A, Part B, and Part C), open-label, multicenter study of boceprevir in pediatric participants with chronic hepatitis C (CHC) genotype 1 (GT1). In Part A and Part B, efficacy and safety will be evaluated in participants with CHC GT1 who are non-cirrhotic, treatment naïves (Part A) or who are non-cirrhotic, treatment failures to (peg)interferon/ribavirin or who are cirrhotics (whether treatment naïve or treatment failure) (Part B). Part C is long-term follow up and no study treatment will be administered during this period, but participants who do not achieve viral clearance will be allowed to receive other treatments for CHC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CHC GT1 infection for at least 6 months with with HCV-RNA ≥10,000 IU/mL.
- •Treatment naive, non-cirrhotic participants will be eligible for inclusion in Study Part A
- •Non-cirrhotic subjects who failed previous (peg)interferon/ribavirin treatment for CHC and cirrhotics, whether treatment naive or treatment failure, will be eligible for inclusion in Study Part B
- •To participate in Study Part C, participants must have completed the required post-treatment follow-up in Study Part A or Part B
- •Weight ≥ 10 kg to ≤ 125 kg
- •Body surface area (BSA) ≥0.46 m^2 and ≤2.5 m^2
- •Previous liver biopsy with histology consistent with chronic hepatitis C and no other etiology within 2 years of the screening visit
- •Participants with bridging fibrosis or cirrhosis must have an ultrasound within 6 months of the screening visit or between the screening visit and Day 1 with no findings suspicious for hepatocellular carcinoma
- •Participant must be able to adhere to dose and visit schedules
排除标准
- •Known co-infection with the the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive)
- •For Study Part A, participant received any prior hepatitis C treatment, including herbal remedies, with known hepatotoxicity
- •For Study Part B, participant received treatment with ribavirin within 90 days or any interferon alpha within 30 days prior to screening
- •For Study Part B, participant received previous treatment with a hepatitis C virus protease inhibitor (excepting participants in study P07614, Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1)
- •For Study Part B, participant required discontinuation of previous (peg)interferon/ribavirin therapy for an adverse event considered by the investigator to be related to (peg)interferon and/or ribavirin
- •For Study Part B, participant is currently taking any antiviral/immunomodulatory treatment for hepatitis C
- •Participant has taken any investigational drugs, except boceprevir
- •Participant has received any of the following medication(s) within 2 weeks prior to the Day 1 visit: midazolam, pimozide, amiodarone, flecainide,
- •propafenone, quinidine, and ergot derivatives (dihydroergotamine, ergonovine,
- •ergotamine, methylergonovine)
- •Participation in any other clinical trial within 30 days of enrollment or
- •intent to participate in another clinical trial during participation in the current study
- •Evidence of decompensated liver disease
- •Child Pugh score >6 (class B and C)
- •History of diabetes or hypertension or was born prior to 32 weeks
- •of gestation and has clinically significant ocular examination findings
- •Pre-existing clinically significant psychiatric condition(s)
- •Clinical diagnosis of substance abuse
- •Any pre-existing medical condition that could interfere with participation in and completion of the study
- •Evidence of active or suspected malignancy
- •Females who are pregnant, nursing, or intend to become pregnant during
- •the study period
- •Allergy or sensitivity to the investigational products or excipients
研究组 & 干预措施
Part A: boceprevir + peginterferon alpha-2b + ribavirin
Experimental
干预措施: Boceprevir (Drug)
Part A: boceprevir + peginterferon alpha-2b + ribavirin
Experimental
干预措施: Peginterferon alpha-2b (Drug)
Part A: boceprevir + peginterferon alpha-2b + ribavirin
Experimental
干预措施: Ribavirin (Drug)
Part B: boceprevir + peginterferon alpha-2b + ribavirin
Experimental
干预措施: Boceprevir (Drug)
Part B: boceprevir + peginterferon alpha-2b + ribavirin
Experimental
干预措施: Peginterferon alfa-2b (Drug)
Part B: boceprevir + peginterferon alpha-2b + ribavirin
Experimental
干预措施: Ribavirin (Drug)
结局指标
主要结局
Participants Achieving SVR at Follow-Up Week 24 in Study Part B
时间窗: Follow-Up Week 24
Time to Viral Relapse in Study Part C
时间窗: Follow-Up Week 24 to 5 Years
Participants Achieving Sustained Viral Response (SVR) at Follow-Up Week 24 in Study Part A
时间窗: Follow-Up Week 24
次要结局
- Proportion of Participants With Undetectable HCV-RNA in Study Part B(Week 24, End of Treatment, Follow-Up Week 12)
- Proportion of Participants With Undetectable HCV-RNA Who Also Achieved SVR in Study Part B(Follow-Up Week 12)
- Number of Participants Experiencing Treatment-Emergent Adverse Events (AEs) in Study Part A(Week 1 to Follow-Up Visit 24)
- Participants Discontinuing Treatment Due to AEs in Study Part A(Week 1 to Follow-Up Week 24)
- Change from Baseline in Participant Laboratory Values in Study Part A(Baseline to Follow-Up Week 24)
- Number of Participants Experiencing SAEs in Study Part B(Week 1 to Follow-Up Week 24)
- Proportion of Participants With Alanine Aminotransferase (ALT) Normalization in Study Part A(Week 2, Week 4, Week 8, Week 12)
- Number of Participants Discontinuing From Study Treatment Due to AEs in Study Part B(Week 1 to Follow-Up Week 24)
- Participants With Early Virologic Response in Study Part A(Week 2, Week 4, Week 8, Week 12)
- Proportion of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) in Study Part A(Week 12, End of Treatment, Follow-Up Week 24)
- Proportion of Participants With Undetectable HCV-RNA Who Also Achieved SVR in Study Part A(Follow-Up Week 12)
- Proportion of Participants With Alanine Aminotransferase (ALT) Normalization in Study Part B(Week 2, Week 4, Week 8, Week 12)
- Number of Participants Experiencing Treatment-Emergent Treatment-Related AEs in Study Part A(Week 1 to Follow-Up Week 24)
- Number of Participants Experiencing Serious AEs (SAEs) in Study Part A(Week 1 to Follow-Up Week 24)
- Change From Baseline in Participant Vital Signs in Study Part A(Baseline to Follow-Up Week 24)
- Number of Participants Experiencing AEs in Study Part B(Week 1 to Follow-Up Week 24)
- Change from Baseline in Participant Laboratory Values in Study Part B(Week 1 to Follow-Up Week 24)
- Change From Baseline in Participant Vital Signs in Study Part B(Week 1 to Follow-Up Week 24)
研究者
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