Open-label, Multicenter, Trial Evaluating Efficacy and Safety of Peginterferon Alfa-2a (PEGASYS®) in Patients With Chronic Hepatitis D (CHD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 31
- 主要终点
- Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72
研究概览
简要总结
This study evaluated the efficacy and safety of 48-week treatment with pegylated interferon (PEG-IFN) alfa-2a (Pegasys) monotherapy in participants with chronic hepatitis D (CHD). Treatment was followed by 24 weeks of treatment-free follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Positive hepatitis B surface antigen (HBsAg) for at least 6 months prior to screening
- •Positive anti-delta for at least 3 months prior to screening
- •Positive hepatitis D virus (HDV) ribonucleic acid (RNA)
- •A liver biopsy obtained within the past 18 months for non-cirrhotic patients and 30 months for cirrhotic patients demonstrating liver disease consistent with chronic hepatitis D (CHD)
- •Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug
排除标准
- •Antiviral therapy for CHD within the previous 6 months
- •Positive hepatitis A, hepatitis C, or human immunodeficiency virus (HIV)
- •Evidence of decompensated liver disease
- •Other medical condition associated with chronic liver disease
- •Women with ongoing pregnancy or who are breast feeding
研究组 & 干预措施
Pegylated Interferon (PEG-IFN) alfa-2a
Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.
干预措施: Pegylated Interferon (PEG-IFN) alfa-2a (Drug)
结局指标
主要结局
Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72
时间窗: At Week 72
Samples were collected and analyzed for ALT. A normal ALT is a value within the normal range of the assay.
Percentage of Participants With Negative Hepatitis D Virus Ribonucleic Acid (HDV RNA) at Week 72
时间窗: At Week 72
Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay.
次要结局
- Percentage of Participants With Normal ALT at Week 48(At Week 48)
- Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 Copies/Milliliter (mL) at Weeks 48 and 72(At Weeks 48 and 72)
- Percentage of Participants With Negative HDV RNA at Week 48(At Week 48)
- Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels(At Screening and at Weeks 48 and 72)
- Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72(At Weeks 48 and 72)
- Percentage of Participants With Positive Hepatitis B Surface Antibody (HBsAb) at Weeks 48 and 72(At Weeks 48 and 72)