Phase II Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg Positive Chronic Hepatitis B
- Conditions
- Hepatitis B, Chronic
- Interventions
- Registration Number
- NCT02366208
- Lead Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo to match PEG-Tα1 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 PEG-Tα1 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 PEG-Tα1 Adefovir 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 Placebo to match PEG-Tα1 Adefovir PEG-Tα1 placebo (1ml, once a week, taken subcutaneously) for 24 weeks and adefovir (10 mg, once daily, taken orally) for 48 weeks
- Primary Outcome Measures
Name Time Method loss of HBeAg 48 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (12)
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
302 Military Hoapital of China
🇨🇳Beijing, Beijing, China
Hainan General Hospital
🇨🇳Haikou, Hainan, China
The Third Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
81 Military Hospital of China
🇨🇳Nanjing, Jiangsu, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
The Second Hospital of Nanjing
🇨🇳Nanjing, Jiangsu, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The Sixth People's Hospital of Shenyang
🇨🇳Shenyang, Liaoning, China
West China Hospital Sichuan University
🇨🇳Chengdu, Sichuan, China