Trial | NCT02366208  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    116
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 Started
May 31
2011
Primary Completion
Jun 30
2013
Study Completion
Aug 31
2013
Last Update
Feb 19
2015
Estimate

Drug PEG-Tα1

1.6 mg/ml, once a week, taken subcutaneously

  • Other names: Polyethylene Glycol Thymosin alpha1

Drug Placebo to match PEG-Tα1

1ml, once a week, taken subcutaneously

Drug Adefovir

10 mg, once daily, taken orally for 48 weeks

PEG-Tα1 Experimental

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 to match PEG-Tα1 Placebo Comparator

PEG-Tα1 placebo (1ml, once a week, taken subcutaneously) for 24 weeks and adefovir (10 mg, once daily, taken orally) for 48 weeks

Criteria 

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.
No Results Posted