Overview

This trial is active, not recruiting.

Condition hepatitis b, chronic
Treatments peg-tα1, placebo to match peg-tα1, adefovir
Phase phase 3
Sponsor Jiangsu Hansoh Pharmaceutical Co., Ltd.
Collaborator Nanjing Medical University
Start date August 2013
End date December 2015
Trial size 463 participants
Trial identifier NCT02366247, HS-20046-3

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
PEG-Tα1 (3.2 mg/ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 48 weeks
peg-tα1 Polyethylene Glycol thymosin alpha1
3.2mg/ml, once a week, taken subcutaneously
adefovir
10 mg, once daily, taken orally for 48 weeks
(Placebo Comparator)
PEG-Tα1 placebo (1ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 48 weeks
placebo to match peg-tα1
1ml, once a week, taken subcutaneously
adefovir
10 mg, once daily, taken orally for 48 weeks

Primary Outcomes

Measure
Loss of HBeAg
time frame: 48 weeks

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title 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 Ⅲ Trial
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Jiangsu Hansoh Pharmaceutical Co., Ltd..