A Phase IIb, Open Label, Single Arm, Multicenter Study to Evaluate the Effect of 48-weeks PEG-Interferon Alfa-2a (PEG-IFN) Administration on Serum HBsAg in Chronic Hepatitis B, HBeAg-Negative, Genotype D Patients on Treatment With Nucleos(t)Ide Analogues (NAs), Showing Stable HBV DNA Suppression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 13
- 主要终点
- Efficacy: Percent Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at End of the Combination Treatment (Week 48)
研究概览
简要总结
This open-label, single-arm, multicenter study will evaluate the efficacy and safety of adding Pegasys (peginterferon alfa-2a) to nucleos(t)ide analogue (NAs) treatment in participants with HBeAg-negative chronic hepatitis B genotype D showing stable HBV DNA suppression. After a 12-week Lead-in period on treatment with NA, participants with a HBsAg decline <0.5 log10 IU/ml will enter the Add-on period to receive Pegasys 180 mcg subcutaneously weekly for 48 weeks in addition to their current NA treatment. Follow-up will be a further 48 weeks, during which the participants will continue their NA treatment.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants, 18 - 65 years of age
- •Chronic hepatitis B
- •Negative for HBeAg
- •On monotherapy with any nucleos(t)ide analogue (NA) but telbivudine at enrolment, and HBV DNA persistently below 20 IU/ml for at least 12 months
- •HBsAg >100 IU/ml at the beginning of the Lead-in phase, confirmed before addition of Pegasys
- •Showing a steady HBsAg kinetic (HBsAg decrease <0.5 log10 IU/ml from Week -12 to start of the Add-on phase)
- •Negative pregnancy test for women of childbearing potential
- •Women of childbearing potential and fertile males with female partners of childbearing potential must be using reliable contraception during and for 3 months after the Add-on phase
排除标准
- •Coinfection with Hepatitis A virus (HAV), Hepatitis C virus (HCV), Hepatitis D virus (HDV), Human Immunodeficiency virus (HIV)
- •Evidence of decompensated liver disease (Child-Pugh >/=6)
- •History or other evidence of a medical condition associated with chronic liver disease (e.g. hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure)
- •Known hypersensitivity to peginterferon alfa-2a
- •Pregnant of breastfeeding women
- •Evidence of alcohol and/or drug abuse
- •History of severe psychiatric disease, especially depression
- •History of immunologically mediated disease
- •History or evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
- •History or evidence of severe pulmonary disease associated with functional limitations
- •History of severe cardiac disease
- •History of severe seizure disorder or current anticonvulsant use
- •Evidence of an active or suspected cancer or a history of malignancy (other than basocellular carcinoma or in situ cervical carcinoma) within 5 years prior to study entry
- •History of having received any systemic anti-neoplastic (including radiation) or immunomodulatory (including systemic corticosteroids) treatment </= 6 months prior to the first dose or the expectation that such a treatment will be needed at any time during the study
- •History or other evidence of severe retinopathy
研究组 & 干预措施
Pegylated Interferon (Peginterferon) Alfa-2a
Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
干预措施: Pegylated Interferon (Peginterferon) Alfa-2a (Drug)
Pegylated Interferon (Peginterferon) Alfa-2a
Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
干预措施: Nucleos(t)ide Analogues (NA) (Drug)
结局指标
主要结局
Efficacy: Percent Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at End of the Combination Treatment (Week 48)
时间窗: Baseline up to Week 48
Efficacy: Percentage of Participants With Serum Hepatitis B Surface Antigen (HBsAg) Decrease >/= 50% From Baseline at End of the Combination Treatment (Week 48)
时间窗: Baseline and Week 48
Participants who stopped pegylated interferon (PEG-IFN) treatment during the add-on phase due to serum HBsAg loss and HBsAg seroconversion were considered as responders.
次要结局
- Efficacy: Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at Week 24, 72 and 96(Baseline, Week 24, 72 and 96)
- Efficacy: Percentage of Participants With HBsAg Decrease >/=1 log10 IU/ml From Baseline to Week 48(Baseline, Week 48)
- Efficacy: HBsAg Levels According to Interferon-Inducible Protein 10 (IP-10) Serum Levels(Baseline and Week 48)
- Efficacy: Number of Participants With Serum HBsAg Loss at Week 12 That Persisted up to Week 96(Week 12 up to Week 96)
- Efficacy: HBsAg Levels According to Interleukin 28B (IL28B) Genotypes(Baseline and Week 48)
- Safety: Percentage of Participants With Adverse Events (AE)(Baseline up to Week 48)