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Trial · Interventional

Status unknownPhase 3Registry data

Phase Ⅲ Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg-positive Chronic Hepatitis B

Short name PEG-Tα1

NCTNCT02366247 (opens ClinicalTrials.gov in a new tab)Other idHS-20046-3
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 3
Enrollment
463 participants (actual)
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
Design
Randomized · Quadruple masking
Countries
1 country

China

Start
Aug 2013
Primary completion
Dec 2015 (estimated)
Completion
Feb 2016 (estimated)
First posted
19 Feb 2015 (estimated)
Last update posted
19 Feb 2015 (estimated)
Conditions
Hepatitis B, Chronic

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20132014201520162017
  1. Ph 3

    PEG-Tα1

    NCT02366247

    Aug 2013 to est. Feb 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • PEG-Tα1Drug
  • Placebo to match PEG-Tα1Drug
  • AdefovirDrug

Arms2

  • Experimental

    PEG-Tα1

    PEG-Tα1 (3.2 mg/ml, once a week, taken subcutaneously) 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) and adefovir (10 mg, once daily, taken orally) for 48 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Loss of HBeAg

    Time frame · 48 weeks

Secondary outcomes(3)

  1. Loss of HBV DNA

    Time frame · week 4, 12, 24, 36 and 48

  2. HBeAg seroconversion

    Time frame · week 4, 12, 24, 36 and 48

  3. Alanine aminotransferase normalization

    Time frame · week 4, 12, 24, 36 and 48

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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