A Randomized, Pilot, Open-Label, Monocenter, Efficacy and Safety Study Examining the Effects of Peginterferon Alfa-2a (Pegasys) With or Without Ribavirin (Copegus) in Patients With Chronic Hepatitis D
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment
研究概览
简要总结
This single-center, randomized, open-label, pilot study is designed to evaluate the efficacy and safety of 48 weeks of treatment with peginterferon alfa-2a alone versus in combination with ribavirin in participants with CHD.
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
- •Positive hepatitis B surface antigen (HBsAg) for the prior 6 months
- •Positive anti-delta for the prior 3 months
- •Positive HDV RNA at Screening
- •Elevated ALT (1 to 10 times upper limit of normal) prior to first dose
- •Chronic, necroinflammatory hepatitis documented within the prior 18 months (non-cirrhotic) or 30 months (cirrhotic)
- •Negative pregnancy and adequate contraceptive use
排除标准
- •Antiviral therapy for CHD within previous 3 months
- •Positive for hepatitis A or C, or human immunodeficiency virus (HIV)
- •Increased risk of metabolic liver disease
- •Decompensated liver disease
- •Elevated bilirubin
- •Poor hematologic or renal function
- •Drug/alcohol abuse within 1 year prior to study
- •History of significant psychiatric, autoimmune, pulmonary, cardiac, oncologic, or thyroid disease
- •Organ transplantation with existing functional graft
- •Retinopathy or other ophthalmologic complication of diabetes or hypertension
- •Inclusion in another investigational trial within previous 12 weeks
研究组 & 干预措施
Group A: Monotherapy with Peginterferon alfa-2a
Participants will receive peginterferon alfa-2a alone, administered over 48 weeks.
干预措施: Peginterferon alfa-2a (Drug)
Group B: Combination with Peginterferon alfa-2a + Ribavirin
Participants will receive combination therapy with peginterferon alfa-2a plus ribavirin, administered over 48 weeks.
干预措施: Peginterferon alfa-2a (Drug)
Group B: Combination with Peginterferon alfa-2a + Ribavirin
Participants will receive combination therapy with peginterferon alfa-2a plus ribavirin, administered over 48 weeks.
干预措施: Ribavirin (Drug)
结局指标
主要结局
Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment
时间窗: Week 96
Normalized ALT was defined as ALT value above the upper limit of normal (ULN) at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). Negative HDV RNA was defined as HDV RNA not detected by polymerase chain reaction (PCR). The number of participants with ALT normalization and negative HDV RNA at Week 96 was reported.
次要结局
- Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment(Week 96)
- Number of Participants With Negative HDV RNA at End of Treatment(Week 48)
- Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment(Week 48)
- Number of Participants With ALT Normalization at 48 Weeks After End of Treatment(Week 96)
- Number of Participants With ALT Normalization at End of Treatment(Week 48)