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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
463
Loss of HBeAg
Time frame: 48 weeks
Loss of HBV DNA
Time frame: week 4, 12, 24, 36 and 48
HBeAg seroconversion
Time frame: week 4, 12, 24, 36 and 48
Alanine aminotransferase normalization
Time frame: week 4, 12, 24, 36 and 48
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302 Military Hoapital of China
Beijing, Beijing Municipality, China
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Southwest Hospital
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 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
...and 22 more locations