NCT01651403进行中（未招募）3 期
A Randomized, Double-Blind Evaluation of the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Patients With Chronic Hepatitis B Infection
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 21
- 主要终点
- Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Failure Approach)
研究概览
简要总结
The primary objective of this study is to evaluate the antiviral efficacy of tenofovir disoproxil fumarate (tenofovir DF; TDF) versus placebo in pediatric population (aged 2 to < 12 years at the time of enrollment) with chronic hepatitis B (CHB) infection.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female, 2 to < 12 years of age
- •Weight ≥ 10 kg
- •Chronic HBV infection ≥ 6 months
- •Hepatitis B e antigen (HBeAg)-positive or HBeAg-negative
- •HBV Viral Load ≥ 100,000 copies/mL
- •Alanine aminotransferase (ALT) ≥ 1.5 x the upper limit of the normal range (ULN) at screening
- •Creatinine Clearance ≥ 80 mL/min/1.73m^2
- •Absolute neutrophil count (ANC) ≥ 1,500/mm^3, hemoglobin ≥ 10 g/dL
- •Negative pregnancy test at screening
- •No prior tenofovir DF therapy (participants may have received prior interferon-alfa and/or other oral anti-HBV nucleoside/nucleotide therapy; participants must have discontinued interferon-alfa therapy ≥ 6 months prior to screening; participants experienced on other anti-HBV nucleoside/nucleotide therapy must have discontinued therapy ≥ 16 weeks prior to screening to avoid flare if randomized to the placebo arm)
排除标准
- •Pregnant or lactating
- •Decompensated liver disease
- •Received interferon therapy within 6 months of screening
- •Received anti-HBV nucleoside/nucleotide therapy within 16 weeks of screening
- •Alpha-fetoprotein levels > 50 ng/mL
- •Evidence of hepatocellular carcinoma (HCC)
- •Co-infection with human immunodeficiency virus (HIV), acute hepatitis A virus (HAV), hepatitis C virus (HCV), or hepatitis D virus (HDV)
- •Chronic liver disease not due to HBV
- •History of significant renal, cardiovascular, pulmonary, neurological or bone disease
- •Long term non-steroidal, anti-inflammatory drug therapy
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Tenofovir DF (Blinded Randomized Treatment)
Experimental
Participants will receive tenofovir disoproxil fumarate (tenofovir DF; TDF) for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3).
干预措施: Tenofovir DF (Drug)
Placebo to match TDF (Blinded Randomized Treatment)
Placebo Comparator
Participants will receive TDF placebo for 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3).
干预措施: TDF Placebo (Drug)
Tenofovir DF (Open-label Treatment)
Experimental
Following 72 weeks (protocol amendment 2) or 48 weeks (protocol amendment 3) of blinded randomized treatment, participants will switch to open-label TDF treatment for an additional 120 weeks (protocol amendment 2) or 144 weeks (protocol amendment 3).
干预措施: Tenofovir DF (Drug)
Tenofovir DF (Open-label Extension Phase)
Experimental
Following the completion of study at Week 192, participants may have the option to receive open-label TDF until it is commercially available in that country for treatment of chronic HBV in participants of their age and weight.
干预措施: Tenofovir DF (Drug)
结局指标
主要结局
Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Failure Approach)
时间窗: Week 48
Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Excluded Approach)
时间窗: Week 48
次要结局
- Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48(Week 48)
- Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 48, Based on the American Association for the Study of Liver Diseases (AASLD) Normal Range(Week 48)
- Percentage of Participants With Normal ALT at Week 192, Based on the AASLD Normal Range(Week 192)
- Percentage of Participants With Normal ALT at Week 48, Based on the Central Lab Normal Range(Week 48)
- Percentage of Participants With Normal ALT at Week 192, Based on the Central Lab Normal Range(Week 192)
- Percentage of Participants With Normalized ALT at Week 48, Based on the AASLD Normal Range(Week 48)
- Percentage of Participants With Normalized ALT at Week 192, Based on the AASLD Normal Range(Week 192)
- Percentage of Participants With Normalized ALT at Week 48, Based on the Central Lab Normal Range(Week 48)
- Percentage of Participants With Normalized ALT at Week 192, Based on the Central Lab Normal Range(Week 192)
- Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on AASLD Normal Range) at Week 48(Week 48)
- Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on AASLD Normal Range) at Week 192(Week 192)
- Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on Central Lab Normal Range) at Week 48(Week 48)
- Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on Central Lab Normal Range) at Week 192(Week 192)
- Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 48(Week 48)
- Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 192(Week 192)
- Percentage of Participants With HBsAg Loss at Week 48(Week 48)
- Percentage of Participants With HBsAg Loss at Week 192(Week 192)
- Percentage of Participants With HBsAg Seroconversion at Week 48(Week 48)
- Percentage of Participants With HBsAg Seroconversion at Week 192(Week 192)
- Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 48(Baseline; Week 48)
- Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 96(Baseline; Week 96)
- Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 144(Baseline; Week 144)
- Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 192(Baseline; Week 192)
- Percentage of Participants With ≥ 4% Decrease From Baseline in Spine Bone Mineral Density (BMD) at Week 48(Baseline; Week 48)
- Percentage of Participants With ≥ 4% Decrease From Baseline in Spine BMD at Week 192(Baseline; Week 192)
- Percent Change From Baseline in BMD of Spine at Week 48(Baseline; Week 48)
- Percent Change From Baseline in BMD of Spine at Week 192(Baseline; Week 192)
研究者
研究点 (21)
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