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Study · Randomized controlled trial · 2022

5 results

Safety and efficacy of Thymosin α1 in the treatment of hepatitis B virus-related acute-on-chronic liver failure: a randomized controlled trial.

Chen JF, Chen SR, Lei ZY, Cao HJ, Zhang SQ, Weng WZ, Xiong J, Lin DN, Zhang J, Zheng YB, Gao ZL, Lin BL

Hepatology international26 May 2022Cited by 9 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with HBV-related acute-on-chronic liver failure, 90-day transplantation-free survival was higher with thymosin α1 (75.0%) than with standard medical therapy alone (53.4%; p = 0.030).

    In plain wordsIn people with hepatitis B liver failure, thymosin α1 gave higher 90-day transplant-free survival than standard care alone.

    Outcome
    Increase90-day liver transplantation-free survival
    Study

    n: not reported in source

    Comparator
    Standard medical therapy
    Outcome group
    Mortality · Liver
    Studied dose
    1.6 mg once a day in week 1, then twice a week from week 2 to week 12 · subcutaneous · 12 weeksAs given in this study (human).

    Measurements

    90-day transplantation-free survival
    75%
    Tα1 group
    90-day transplantation-free survival
    53.4%
    SMT group

    Source sentences

    Summary
    The 90-day cumulated liver transplantation free survival rate of the Tα1 group was 75.0% (95% confidence interval 63.2-86.8%) versus 53.4% (95% confidence interval 39.7-67.1%) for the SMT group (p = 0.030).
    2 context sentences
    Summary · context
    From 2017 to 2019, 120 patients with HBV-related ACLF were enrolled in this open-label, randomized, and controlled clinical trial (ClinicalTrial ID: NCT03082885).
    Summary · context
    The experimental group (N = 56) was subcutaneously injected with 1.6 mg of Tα1 once a day for the first week and then twice a week from week 2 to week 12.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with HBV-related acute-on-chronic liver failure, competing-risk analysis found no significant survival difference between thymosin α1 and standard medical therapy.

    In plain wordsIn people with hepatitis B liver failure, a second survival analysis found no clear difference between thymosin α1 and standard care.

    Outcome
    No significant changeSurvival by competing-risk analysis
    Study

    n: not reported in source

    Comparator
    Standard medical therapy
    Outcome group
    Mortality · Liver
    Studied dose
    1.6 mg once a day in week 1, then twice a week from week 2 to week 12 · subcutaneous · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    No significant difference was found in the survival using competitive risk analysis.
    2 context sentences
    Summary · context
    From 2017 to 2019, 120 patients with HBV-related ACLF were enrolled in this open-label, randomized, and controlled clinical trial (ClinicalTrial ID: NCT03082885).
    Summary · context
    The experimental group (N = 56) was subcutaneously injected with 1.6 mg of Tα1 once a day for the first week and then twice a week from week 2 to week 12.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with HBV-related acute-on-chronic liver failure, new infections were less frequent with thymosin α1 than with standard medical therapy (32.1% vs 58.6%, p = 0.005).

    In plain wordsIn people with hepatitis B liver failure, new infections were less common with thymosin α1 than with standard care alone.

    Outcome
    DecreaseIncidence of new infection
    Study

    n: not reported in source

    Comparator
    Standard medical therapy
    Outcome group
    Infection and antimicrobial activity · Infection
    Studied dose
    1.6 mg once a day in week 1, then twice a week from week 2 to week 12 · subcutaneous · 12 weeksAs given in this study (human).

    Measurements

    New infection incidence
    32.1%
    Tα1 group
    New infection incidence
    58.6%
    SMT group

    Source sentences

    Summary
    The incidences of new infection and hepatic encephalopathy in the Tα1 group were much lower than those in the SMT group (32.1% vs 58.6%, p = 0.005; 8.9% vs 24.1%, p = 0.029, respectively).
    2 context sentences
    Summary · context
    From 2017 to 2019, 120 patients with HBV-related ACLF were enrolled in this open-label, randomized, and controlled clinical trial (ClinicalTrial ID: NCT03082885).
    Summary · context
    The experimental group (N = 56) was subcutaneously injected with 1.6 mg of Tα1 once a day for the first week and then twice a week from week 2 to week 12.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with HBV-related acute-on-chronic liver failure, hepatic encephalopathy was less frequent with thymosin α1 than with standard medical therapy (8.9% vs 24.1%, p = 0.029).

    In plain wordsIn people with hepatitis B liver failure, hepatic encephalopathy was less common with thymosin α1 than with standard care alone.

    Outcome
    DecreaseIncidence of hepatic encephalopathy
    Study

    n: not reported in source

    Comparator
    Standard medical therapy
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    1.6 mg once a day in week 1, then twice a week from week 2 to week 12 · subcutaneous · 12 weeksAs given in this study (human).

    Measurements

    Hepatic encephalopathy incidence
    8.9%
    Tα1 group
    Hepatic encephalopathy incidence
    24.1%
    SMT group

    Source sentences

    Summary
    The incidences of new infection and hepatic encephalopathy in the Tα1 group were much lower than those in the SMT group (32.1% vs 58.6%, p = 0.005; 8.9% vs 24.1%, p = 0.029, respectively).
    2 context sentences
    Summary · context
    From 2017 to 2019, 120 patients with HBV-related ACLF were enrolled in this open-label, randomized, and controlled clinical trial (ClinicalTrial ID: NCT03082885).
    Summary · context
    The experimental group (N = 56) was subcutaneously injected with 1.6 mg of Tα1 once a day for the first week and then twice a week from week 2 to week 12.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In patients with HBV-related acute-on-chronic liver failure, mortality from severe infection was lower with thymosin α1 (8.9%) than with standard medical therapy (24.1%; p = 0.029).

    In plain wordsIn people with hepatitis B liver failure, fewer deaths from severe infection occurred with thymosin α1 than with standard care alone.

    Outcome
    DecreaseMortality from severe infection
    Study

    n: not reported in source

    Comparator
    Standard medical therapy
    Outcome group
    Mortality · Infection
    Studied dose
    1.6 mg once a day in week 1, then twice a week from week 2 to week 12 · subcutaneous · 12 weeksAs given in this study (human).

    Measurements

    Mortality from severe infection
    8.9%
    Tα1 group
    Mortality from severe infection
    24.1%
    SMT group

    Source sentences

    Summary
    Mortality from severe infection in the SMT group was higher than in the Tα1 group (24.1% vs 8.9%, p = 0.029).
    2 context sentences
    Summary · context
    From 2017 to 2019, 120 patients with HBV-related ACLF were enrolled in this open-label, randomized, and controlled clinical trial (ClinicalTrial ID: NCT03082885).
    Summary · context
    The experimental group (N = 56) was subcutaneously injected with 1.6 mg of Tα1 once a day for the first week and then twice a week from week 2 to week 12.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 3Current

    9 Oct 2026, 18:17 UTC

    Study results updated

  2. Version 2

    9 Oct 2026, 03:03 UTC

    Study data updated · source update from Europe PMC

  3. Version 1

    9 Oct 2026, 03:02 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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