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

Jiangsu Hansoh Pharmaceutical Co., Ltd.116 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

116

Conditions

Hepatitis B, Chronic

Interventions

PEG-Tα1DRUG

1.6 mg/ml, once a week, taken subcutaneously

Placebo to match PEG-Tα1DRUG

1ml, once a week, taken subcutaneously

AdefovirDRUG

10 mg, once daily, taken orally for 48 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (12)

302 Military Hoapital of China

Beijing, Beijing Municipality, China

Hainan General Hospital

Haikou, Hainan, China

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Outcomes

Primary Outcomes

loss of HBeAg

Time frame: 48 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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