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Study · Randomized controlled trial · n = 73 · 2026

5 results

Thymosin α1 improves the outcomes of patients with hepatitis B virus-related acute-on-chronic liver failure by restoring immune balance.

Li ZH, Wu LL, Zhu YQ, Hu ZX, Meng SB, Lei ZY, Cao HJ, Wang JL, Chen JF, Zhang J, Lin BL

Immunopharmacology and immunotoxicology26 Mar 2026

PMID41887933 (opens in a new tab)DOI10.1080/08923973.2026.2641686 (opens in a new tab)PepBankPUB-41887933
Publisher pagePubMedAsk about this study
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Summary

BackgroundThymosin α1 (Tα1) has been shown to improve survival in patients with hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF), but its immunomodulatory mechanisms remain unclear. This study investigated how Tα1 restores immune homeostasis to confer a survival benefit in these patients.MethodsIn this open-label, randomized controlled trial (NCT03082885), 73 patients with HBV-ACLF received either standard medical therapy (SMT, n = 38) or SMT plus Tα1 (n = 35). Peripheral blood immune cell subsets were analyzed by flow cytometry and serum cytokine levels were measured by ELISA. Patients were stratified by 90-day transplant-free survival.ResultsPatients who survived at 90 days exhibited a higher proportion of effector T (TE) cells and lower levels of regulatory T cells (Tregs) at baseline compared to non-survivors. Survivors also had significantly higher initial levels of pro-inflammatory cytokines (IL-6, TNF-α, IFN-γ) and lower levels of TGF-β. Over time, survivors showed a gradual decline in inflammatory markers, whereas non-survivors developed a progressive inflammatory storm. Tα1 treatment significantly increased 90-day transplant-free survival and was associated with reduced frequencies of Tregs and CD226low/- Treg subsets at weeks 4-8. Tα1 also moderated the late-stage hyperinflammatory response without compromising early immune activation.ConclusionsTα1 improves clinical outcomes in HBV-ACLF by rebalancing the immune response-mitigating excessive inflammation and preventing immune paralysis by modulating T-cell differentiation and cytokine production, thereby breaking the cycle of hyperinflammation and immunosuppression that characterizes ACLF progression.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

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, adding thymosin alpha‑1 to standard medical therapy increased 90-day transplant-free survival.

    In plain wordsIn people with HBV-related acute-on-chronic liver failure, adding thymosin alpha‑1 to standard care raised 90-day transplant-free survival.

    Peptide
    Thymosin alpha-1
    Outcome
    Increase90-day transplant-free survival
    Study

    n = 73

    Comparator
    Standard medical therapy (SMT) alone
    Outcome group
    Mortality · Liver
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Tα1 treatment significantly increased 90-day transplant-free survival and was associated with reduced frequencies of Tregs and CD226low/- Treg subsets at weeks 4-8.
    1 context sentence
    Summary · context
    In this open-label, randomized controlled trial (NCT03082885), 73 patients with HBV-ACLF received either standard medical therapy (SMT, n = 38) or SMT plus Tα1 (n = 35).
  2. 02HumanRandomized controlled trialMechanism

    In patients with HBV-related acute-on-chronic liver failure, thymosin alpha‑1 was associated with lower regulatory T cell frequencies at weeks 4-8.

    In plain wordsIn people with HBV-related liver failure, thymosin alpha‑1 was linked to fewer regulatory T cells at weeks 4-8.

    Peptide
    Thymosin alpha-1
    Outcome
    DecreaseRegulatory T cell frequency at weeks 4-8
    Study

    n = 73

    Comparator
    Standard medical therapy (SMT) alone
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Tα1 treatment significantly increased 90-day transplant-free survival and was associated with reduced frequencies of Tregs and CD226low/- Treg subsets at weeks 4-8.
    1 context sentence
    Summary · context
    In this open-label, randomized controlled trial (NCT03082885), 73 patients with HBV-ACLF received either standard medical therapy (SMT, n = 38) or SMT plus Tα1 (n = 35).
  3. 03HumanRandomized controlled trialMechanism

    In patients with HBV-related acute-on-chronic liver failure, thymosin alpha‑1 was associated with lower frequencies of CD226 low/- Treg subsets at weeks 4-8.

    In plain wordsIn people with HBV-related liver failure, thymosin alpha‑1 was linked to fewer CD226-low regulatory T cells at weeks 4-8.

    Peptide
    Thymosin alpha-1
    Outcome
    DecreaseCD226 low/- Treg subset frequency at weeks 4-8
    Study

    n = 73

    Comparator
    Standard medical therapy (SMT) alone
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Tα1 treatment significantly increased 90-day transplant-free survival and was associated with reduced frequencies of Tregs and CD226low/- Treg subsets at weeks 4-8.
    1 context sentence
    Summary · context
    In this open-label, randomized controlled trial (NCT03082885), 73 patients with HBV-ACLF received either standard medical therapy (SMT, n = 38) or SMT plus Tα1 (n = 35).
  4. 04HumanRandomized controlled trialMechanism

    In patients with HBV-related acute-on-chronic liver failure, thymosin alpha‑1 moderated the late-stage hyperinflammatory response.

    In plain wordsIn people with HBV-related liver failure, thymosin alpha‑1 reduced the late-stage over-active inflammation.

    Peptide
    Thymosin alpha-1
    Outcome
    DecreaseLate-stage hyperinflammatory response
    Study

    n = 73

    Comparator
    Standard medical therapy (SMT) alone
    Outcome group
    Inflammation markers · Immune and inflammation
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Tα1 also moderated the late-stage hyperinflammatory response without compromising early immune activation.
    1 context sentence
    Summary · context
    In this open-label, randomized controlled trial (NCT03082885), 73 patients with HBV-ACLF received either standard medical therapy (SMT, n = 38) or SMT plus Tα1 (n = 35).
  5. 05HumanRandomized controlled trialMechanism

    In patients with HBV-related acute-on-chronic liver failure, thymosin alpha‑1 did not compromise early immune activation.

    In plain wordsIn people with HBV-related liver failure, thymosin alpha‑1 did not reduce early immune activation.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeEarly immune activation
    Study

    n = 73

    Comparator
    Standard medical therapy (SMT) alone
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Tα1 also moderated the late-stage hyperinflammatory response without compromising early immune activation.
    1 context sentence
    Summary · context
    In this open-label, randomized controlled trial (NCT03082885), 73 patients with HBV-ACLF received either standard medical therapy (SMT, n = 38) or SMT plus Tα1 (n = 35).

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

    10 Oct 2026, 08:19 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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