Phase Ⅲ Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg-positive Chronic Hepatitis B

• Status: Unknown status
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Collaborator: Nanjing Medical University
• Treatments: Adefovir; Adefovir dipivoxil; Thymalfasin

Criteria

Inclusion Criteria:

• 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.

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 ≤ 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.