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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02366208

Acronym

PEG-Tα1

Enrollment

116

Registered

2015-02-19

Start date

2011-05-31

Completion date

2013-08-31

Last updated

2015-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

Keywords

Polyethylene Glycol Thymosin alpha1, Adefovir, Hepatitis B e Antigens positive

Brief 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.

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

DRUGPEG-Tα1

1.6 mg/ml, once a week, taken subcutaneously

DRUGPlacebo to match PEG-Tα1

1ml, once a week, taken subcutaneously

DRUGAdefovir

10 mg, once daily, taken orally for 48 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
loss of HBeAg	48 weeks

Secondary

Measure	Time frame
loss of HBV DNA	week 4, 12, 24, 36 and 48
HBeAg seroconversion	week 4, 12, 24, 36 and 48
alanine aminotransferase normalization	week 4, 12, 24, 36 and 48

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026