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

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.

Full Title of Study: “Combination Treatment of Polyethylene Glycol Thymosin alpha1 (PEG-Tα1) and Adefovir for Hepatitis B e Antigen (HBeAg) -Positive Chronic Hepatitis B: A Multi-center Randomized, Double-blind, Parallel-controlled Phase II Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2013

Detailed Description

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.

Interventions

  • Drug: PEG-Tα1
    • 1.6 mg/ml, once a week, taken subcutaneously
  • Drug: Placebo to match PEG-Tα1
    • 1ml, once a week, taken subcutaneously
  • Drug: Adefovir
    • 10 mg, once daily, taken orally for 48 weeks

Arms, Groups and Cohorts

  • Experimental: PEG-Tα1
    • PEG-Tα1 (1.6 mg/ml, once a week, taken subcutaneously) for 24 weeks and adefovir (10 mg, once daily, taken orally) for 48 weeks
  • Placebo Comparator: Placebo to match PEG-Tα1
    • PEG-Tα1 placebo (1ml, once a week, taken subcutaneously) for 24 weeks and adefovir (10 mg, once daily, taken orally) for 48 weeks

Clinical Trial Outcome Measures

Primary Measures

  • loss of HBeAg
    • Time Frame: 48 weeks

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jiangsu Hansoh Pharmaceutical Co., Ltd.
  • Collaborator
    • Nanjing Medical University
  • Provider of Information About this Clinical Study
    • Sponsor

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