Phase II Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg Positive Chronic Hepatitis B
Phase II Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg Positive Chronic Hepatitis B
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 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.
Inclusion Criteria:

 -  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.

 Exclusion Criteria:

 -  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.