Stop Progression of Fibrosis by Administration of Intermittent Continuous Treatment With Peginterferon Alfa-2a. Open-label, Randomized Efficacy and Safety Clinical Trial of Intermittent Continuous Treatment With Peginterferon Alfa-2a (PEGASYS) in Patients With HBeAg Negative Hepatitis B Responding to Prior Treatment With Interferon Alfa (SOFIA -LTT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Stable Virological Response
研究概览
简要总结
This 2 arm study will evaluate the efficacy and safety of intermittent treatment with PEGASYS in HBeAg negative patients with chronic hepatitis B who have demonstrated virological and biochemical response after treatment with interferon alfa. After 48 weeks therapy with interferon alfa, and 24 weeks treatment-free follow-up, eligible patients will be randomized into the PEGASYS or the observational group. Those in the PEGASYS group will receive 4 therapeutic cycles of long term intermittent treatment with PEGASYS (135 micrograms sc weekly for 12 weeks, followed by a treatment-free period of 12 weeks) and those in the observational arm will receive no specific antiviral treatment. The anticipated time on study treatment is 1-2 years, and the target sample size is 100 individuals.
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
- •adult patients, >=18 years of age;
- •liver disease consistent with CHB;
- •evidence of chronic HBeAg-negative CHB prior to initial course of interferon alfa;
- •patients who have responded to previous 48 weeks treatment with interferon alfa.
排除标准
- •coinfection with HCV, HDV or HIV;
- •decompensated liver disease, hepatocellular cancer, or evidence of a medical condition associated with chronic liver disease other than viral hepatitis;
- •any other systemic antiviral, antineoplastic or immunomodulatory treatment <=6 months prior to first dose of randomized treatment.
研究组 & 干预措施
PEGASYS
Participants received 4 treatment cycles of continuous intermittent treatment with PEGASYS® (Peginterferon alfa-2a) . Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 micrograms in 0.5 ml solution in prefilled syringes, applied once weekly subcutaneously and followed by 12 weeks period without treatment.
干预措施: PEGASYS [peginterferon alfa-2a] (Drug)
结局指标
主要结局
Percentage of Participants With Stable Virological Response
时间窗: Up to Week 108
Stable virological response is serum Hepatitis B virus deoxyribonucleic acid (HBV DNA) \<20 000 copies/ml during the treatment (after each 12 weeks) and after the follow-up period (24 weeks after the last treatment period).
次要结局
- Mean Change From Baseline in HBsAg Levels(Up to Week 108)
- Mean Change From Baseline in Hematology(Up to Week 108)
- Percentage of Participants With HBV DNA Levels Under the Lower Limit (Serum HBV DNA Level < 300 Copies/ml) For a Significant Quantity(Up to Week 108)
- Mean Change From Baseline in Bilirubin Indirect and Bilirubin Direct(Up to Week 108)
- Mean Change From Baseline in Protein and Indirect Albumin(Up to Week 108)
- Mean Change From Baseline in Blood Glucose(Up to Week 108)
- Mean Change From Baseline in Thyroid Stimulating Hormone (TSH)(Up to Week 108)
- Mean Change From Baseline in Triiodothyronine and Thyroxine(Up to Week 108)
- Percentage of Participants With Loss of Hepatitis B Surface Antigen(Up to Week 108)
- Fibrosis-4 and Aspartate Aminotransferase to Platelet Ratio Index Scores For Change in Liver Fibrosis(Up to Week 108)
- Percentage of Participants With Stable Virological and Biochemical Response(Up to Week 108)
- Percentage of Participants With HBsAg Seroconversion(Up to Week 108)
- Mean Change From Baseline in Hemoglobin(Up to Week 108)
- Mean Change From Baseline in Clinical Chemistry(Up to Week 108)
- Mean Change From Baseline in Blood Urea(Up to Week 108)
- Mean Change From Baseline in Creatinine and Uric Acid(Up to Week 108)