A Follow-up Study to Evaluate the Long-term Post Treatment Effects of Peginterferon Alfa-2a (PEG-IFN) in Patients With HBeAg Positive Chronic Hepatitis B From the Original Study WV19432(NEPTUNE).
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 383
- 主要终点
- Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion.
研究概览
简要总结
This study is a long-term post-treatment follow-up to study WV19432, which evaluated the efficacy and safety of PEGASYS in patients with HBeAg positive chronic hepatitis B (CHB).Patients who received treatment with PEGASYS, and completed follow-up, are eligible to enter this post-treatment follow-up study. The anticipated time on study was 5 years, and the target sample size is 100-500 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Informed consent for Study WV19432
- •Patients who have completed treatment and follow-up on study WV19432
排除标准
- •As for Study WV19432
研究组 & 干预措施
PEG-IFN 90mcg 24 Wks
Participants received Pegasys (Pegylated interferon alfa-2a [PEG-IFN]) 90 micrograms (mcg) subcutaneously (SC) once a week for 24 weeks in Study WV19432 and entered follow-up (FU) Study MV22430.
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
PEG-IFN 180mcg 24 Wks
Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
PEG-IFN 90mcg 48 Wks
Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
PEG-IFN 180mcg 48 Wks
Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
结局指标
主要结局
Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion.
时间窗: Annually, for up to 5 years
HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe). Missing values were counted as non-response.
Percentage of Participants With HBsAg Loss
时间窗: Annually, for up to 5 years
HBsAg loss is defined as the absence of HBsAg (i.e. a negative result for HBsAg). Missing values were counted as non-response.
次要结局
- Percentage of Participants With HBeAg Loss.(Annually, for up to 5 years)
- Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion.(Annually, for up to 5 years)
- Percentage of Participants With Presence of Anti-Hepatitis B Envelope Antigen (HBe).(Annually, for up to 5 years)
- Percentage of Participants With Presence of Anti-HBs(Annually, for up to 5 years)
- Percentage of Participants With Normalised Alanine Transaminase (ALT)(Annually, for up to 5 years)
- Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 International Unit/Milliliter (IU/mL).(Annually, for up to 5 years)
- Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 International Unit/Milliliter (IU/mL)(Annually, for up to 5 years)
- Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 80 International Unit/Milliliter (IU/mL)(Annually, for up to 5 years)
- Quantitative HBsAg(Annually, for up to 5 years)
- Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B(Up to 5-year FU period)
- Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB)(Up to 5-year FU period)
- Number of Participants With Marked Laboratory Abnormalities(Up to 5-year FU period)