A Multicenter Open-label Study to Evaluate the Safety and Efficacy of PEG-Intron™ Versus PEGASYS™ in Subjects With HBeAg Positive Chronic Hepatitis B and HBeAg Negative Chronic Hepatitis B Protocol No. MK-4031-376-00 (Also Known as SCH 054031, P08450)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 402
- 主要终点
- Percentage of HBeAg(+) Participants Achieving HBeAg Seroconversion at 24 Weeks Post-treatment
研究概览
简要总结
This study is being done to compare the safety and efficacy of PEG-Intron™ to that of PEGASYS™ in participants with chronic hepatitis B (hepatitis B envelope antigen [HBeAg] positive or negative) who have not previously been treated with interferon.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be able to adhere to dose and visit schedules
- •Hepatitis B surface antigen (HBsAg) positive for at least 6 months
- •Anti-HBs negative
- •Female participants of childbearing potential must agree to use an acceptable
- •method of contraception from at least 2 weeks prior to Day 1 and continue until at least 1 month after last dose of study drug
- •Inclusion Criteria for HBeAg(+) participants:
- •Anti-HBe(-)
- •Inclusion Criteria for HBeAg(-) participants:
- •Anti-HBe(+)
排除标准
- •Co-infection with the human immunodeficiency virus (HIV) or hepatitis C or hepatitis D virus
- •Prior treatment with interferon for hepatitis B
- •Use of nucleoside/nucleotide analogues within 6 months of the screening visit or at any time during the study
- •Use of any investigational drug within 30 days of the screening visit
- •Prior treatment with herbal remedies with known hepatotoxicity. All herbal remedies used for hepatitis B treatment must be discontinued before Day 1
- •Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
- •Diabetic and/or hypertensive with clinically significant ocular examination findings
- •History of stroke or transient ischemic attack
- •Immunologically mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], celiac disease, rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, sarcoidosis, severe psoriasis requiring oral or injected treatment, or symptomatic thyroid disorder)
- •Chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, interstitial lung disease, pulmonary fibrosis, sarcoidosis)
- •Current or history of any clinically significant cardiac abnormalities/dysfunction
- •Any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
- •Myelodysplastic syndromes
- •Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair
- •Pregnant or nursing, or intending to become pregnant during the trial period
研究组 & 干预措施
HBeAg(+) PEG-Intron
HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
干预措施: PEG-Intron™ (Biological)
HBeAg(+) PEGASYS
HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
干预措施: PEGASYS™ (Biological)
HBeAg(-) PEG-Intron
HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
干预措施: PEG-Intron™ (Biological)
HBeAG(-) PEGASYS
HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
干预措施: PEGASYS™ (Biological)
结局指标
主要结局
Percentage of HBeAg(+) Participants Achieving HBeAg Seroconversion at 24 Weeks Post-treatment
时间窗: FU Week 24 (Study Week 72)
Blood samples were drawn to assess the participant's seroconversion status at Follow-up (FU) Week 24. HBeAg seroconversion was defined as loss of HBeAg in HBeAg(+) participants and development of antibody to HBeAg.
Percentage of HBeAg(-) Participants Achieving Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels <2000 IU/mL at 24 Weeks Post-treatment
时间窗: FU Week 24 (Study Week 72)
The Roche COBAS TaqMan HBV-(High Pure System Assay) was used to measure HBV DNA in blood samples of HBeAg(-) participants. The percentage of HBeAg(-) participants with HBV DNA \<2000 IU/mL at 24 weeks post-treatment was reported.
次要结局
- Percentage of HBeAg(+) Participants Achieving the Combined Response of HBeAg Seroconversion and HBV DNA <2000 IU/mL at 24 Weeks Post-treatment(FU Week 24 (Study Week 72))
- Percentage of HBeAg(+) Participants Achieving HBV DNA <2000 IU/mL at 24 Weeks Post-treatment(FU Week 24 (Study Week 72))
- Percentage of HBeAg(+) and HBeAg(-) Participants Achieving Alanine Aminotransferase (ALT) Normalization at 24 Weeks Post-treatment(FU Week 24 (Study Week 72))