Phase Ⅲ Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg-positive Chronic Hepatitis B
- Conditions
- Hepatitis B, Chronic
- Interventions
- Registration Number
- NCT02366247
- 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 463 HBeAg-positive patients were recruited from 33 hospitals in China, and randomized to two groups. The combination group received PEG-Tα1 (3.2 mg/ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 48 weeks. The control group received placebo and adefovir. 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
- UNKNOWN
- Sex
- All
- Target Recruitment
- 463
- Chronic hepatitis B for more than 6 months, and didn't accept immunomodulating or anti-viral treatment within 6 months before the trial.
- ALT level > 2 × Upper Limit Normal (ULN).
- Serum bilirubin < 2 × ULN.
- Positive HBeAg and negative HBeAb.
- 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 ≤ 35g/L, or Serum albumin/globulin (A/G) ≤0.9, Neutrophile granulocyte <1.0 E＋09/L, Prothrombin time>ULN＋3 seconds, Cholinesterase<4000U/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.
- Thymosin allergy.
- Pregnant or breast feeding.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo to match PEG-Tα1 Adefovir PEG-Tα1 placebo (1ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 48 weeks PEG-Tα1 PEG-Tα1 PEG-Tα1 (3.2 mg/ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 48 weeks Placebo to match PEG-Tα1 Placebo to match PEG-Tα1 PEG-Tα1 placebo (1ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 48 weeks PEG-Tα1 Adefovir PEG-Tα1 (3.2 mg/ml, once a week, taken subcutaneously) 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 Alanine aminotransferase normalization week 4, 12, 24, 36 and 48 HBeAg seroconversion week 4, 12, 24, 36 and 48 Loss of HBV DNA week 4, 12, 24, 36 and 48
Trial Locations
- Locations (32)
302 Military Hoapital of China
🇨🇳Beijing, Beijing, China
Beijing YouAn Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Southwest Hospital
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The First Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
Shenzhen People's Hospital
🇨🇳Shenzhen, Guangdong, China
Hainan General Hospital
🇨🇳Haikou, Hainan, China
The First Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The Third Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
People's Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
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