Combination Treatment of Polyethylene Glycol Thymosin alpha1 (PEG-Tα1) and Adefovir for Hepatitis B e Antigen (HBeAg) -Positive Chronic Hepatitis B: A Multi-center Randomized, Double-blind, Parallel-controlled Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 12
- 主要终点
- loss of HBeAg
研究概览
简要总结
This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1 (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from Hansoh Pharmaceutical of China, in combination with adefovir in HBeAg-positive patients with chronic hepatitis B.
详细描述
A total of 116 HBeAg-positive patients were recruited from 12 hospitals in China, and randomized to two groups. The combination group (n= 57) received PEG-Tα1 (1.6 mg/ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 24 weeks. The control group (n = 59) received placebo and adefovir. Both groups received adefovir continuously for additional 24 weeks. The primary endpoint was the loss of HBeAg at 48 weeks. The secondary endpoints included 1) loss of hepatitis B virus ( HBV) DNA, 2) HBeAg seroconversion and 3) alanine aminotransferase (ALT) normalization etc. at week 4, 12, 24, 36 and 48. The number of CD4＋and CD8＋T cells was also determined during 48 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Chronic hepatitis B for more than 6 months
- •ALT > 2 × Upper Limit Normal (ULN)
- •Serum bilirubin < 2 × ULN.
- •Positive HBeAg and HBV-DNA between 1.00E＋05 IU/ml and 9.99E＋09 IU/ml.
- •Informed Consent Form (ICF) signed.
排除标准
- •Hepatitis A,C,D,E or HIV infection.
- •Autoimmune hepatitis.
- •Hepatic cirrhosis.
- •Serum creatinine > 1.5 × ULN or Ccr < 50 ml/min, Haemoglobin < 110g/L (male) or < 100g/L (female), Platelet< 80 E＋09/L, Serum albumin ≤ 32g/L, or Serum albumin/globulin (A/G) ≤0.9, Neutrophile granulocyte < 1.0 E＋09/L, Prothrombin time>ULN＋3 seconds, Cholinesterase<2500U/L.
- •Hepatitic carcinoma or Alpha Fetal Protein (AFP) > 100ng/ml
- •Patients with other severe diseases combined, which could affect the therapy.
- •Patients accepted other clinical trial within 6 months before the first administrated.
- •Patients accepted immunomodulating or anti-viral treatment within 6 months before the trial.
- •Patients with autoimmune disease.
- •Thymosin allergy.
- •Pregnant or breast feeding.
研究组 & 干预措施
PEG-Tα1
PEG-Tα1 (1.6 mg/ml, once a week, taken subcutaneously) for 24 weeks and adefovir (10 mg, once daily, taken orally) for 48 weeks
干预措施: PEG-Tα1 (Drug)
PEG-Tα1
PEG-Tα1 (1.6 mg/ml, once a week, taken subcutaneously) for 24 weeks and adefovir (10 mg, once daily, taken orally) for 48 weeks
干预措施: Adefovir (Drug)
Placebo to match PEG-Tα1
PEG-Tα1 placebo (1ml, once a week, taken subcutaneously) for 24 weeks and adefovir (10 mg, once daily, taken orally) for 48 weeks
干预措施: Placebo to match PEG-Tα1 (Drug)
Placebo to match PEG-Tα1
PEG-Tα1 placebo (1ml, once a week, taken subcutaneously) for 24 weeks and adefovir (10 mg, once daily, taken orally) for 48 weeks
干预措施: Adefovir (Drug)
结局指标
主要结局
loss of HBeAg
时间窗: 48 weeks
次要结局
- loss of HBV DNA(week 4, 12, 24, 36 and 48)
- HBeAg seroconversion(week 4, 12, 24, 36 and 48)
- alanine aminotransferase normalization(week 4, 12, 24, 36 and 48)