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Study · Randomized controlled trial · n = 16 · 2003

4 results

A pilot study of thymosin alpha1 therapy for chronic hepatitis B patients.

Arase Y, Tsubota A, Suzuki Y, Suzuki F, Kobayashi M, Someya T, Akuta N, Hosaka T, Saitoh S, Ikeda K, Kobayashi M, Kumada H

Internal medicine (Tokyo, Japan)1 Oct 2003Cited by 6 (Europe PMC)

PMID14606705 (opens in a new tab)DOI10.2169/internalmedicine.42.941 (opens in a new tab)PepBankPUB-14606705
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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 study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with chronic hepatitis B, 6 of 16 patients treated with thymosin alpha‑1 were responders at 24 months.

    In plain wordsIn people with chronic hepatitis B treated with thymosin alpha‑1, 6 of 16 responded.

    Peptide
    Thymosin alpha-1
    Outcome
    Not applicableResponse rate (HBeAg clearance, HBV-DNA negativity, normal ALT) at 24 months
    Study

    n = 16

    Outcome group
    Antiviral activity · Infection
    Studied dose
    0.8 mg or 1.6 mg · two weeks six times weekly, then 22 weeks twice weeklyAs given in this study (human).

    Measurements

    response rate
    37.5%
    all patients

    Source sentences

    Summary
    The response rate was 37.5% (6/16).
    2 context sentences
    Summary · context
    Responders were defined as patients having clearance of hepatitis B e antigen by radioimmunoassay and negativity of hepatitis B virus (HBV)-DNA by branched DNA signal amplification and normalization of serum alanine aminotransferase (ALT) 24 months after initiation of Talpha1 therapy.
    Summary · context
    Sixteen patients were randomly assigned into one of two groups, treated with 0.8 mg of Talpha1 (low dose group; n = 8) or 1.6 mg Talpha1 (high dose group; n = 8), administered six times weekly for two weeks, followed by twice weekly for another 22 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with chronic hepatitis B, response did not differ significantly between the 0.8 mg and 1.6 mg thymosin alpha‑1 groups (p = 0.608).

    In plain wordsIn people with hepatitis B, the low and high doses of thymosin alpha‑1 gave no clearly different results.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeResponse difference between low dose and high dose
    Study

    n = 16

    Comparator
    0.8 mg versus 1.6 mg
    Outcome group
    Antiviral activity · Infection
    Studied dose
    0.8 mg or 1.6 mg · two weeks six times weekly, then 22 weeks twice weeklyAs given in this study (human).

    Source sentences

    Summary
    The difference between low and high dose groups was not statistically significant (p = 0.608).
    1 context sentence
    Summary · context
    Sixteen patients were randomly assigned into one of two groups, treated with 0.8 mg of Talpha1 (low dose group; n = 8) or 1.6 mg Talpha1 (high dose group; n = 8), administered six times weekly for two weeks, followed by twice weekly for another 22 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with chronic hepatitis B, thymosin alpha‑1 therapy had a significant effect on response when a transient acute exacerbation occurred (p = 0.0029).

    In plain wordsIn people with hepatitis B given thymosin alpha‑1, response was linked to a temporary flare of liver enzymes during treatment.

    Peptide
    Thymosin alpha-1
    Outcome
    IncreaseTreatment effect in patients with transient acute exacerbation
    Study

    n: not reported in source

    Outcome group
    Antiviral activity · Infection
    Studied dose
    0.8 mg or 1.6 mg · two weeks six times weekly, then 22 weeks twice weeklyAs given in this study (human).

    Source sentences

    Summary
    Talpha1 therapy had a significant effect when, 1) transient acute exacerbation was present (p = 0.0029), 2) the serum HBV-DNA level was < 100 Meq/ml prior to the commencement of Talpha1 therapy (p = 0.0063).
    1 context sentence
    Summary · context
    Sixteen patients were randomly assigned into one of two groups, treated with 0.8 mg of Talpha1 (low dose group; n = 8) or 1.6 mg Talpha1 (high dose group; n = 8), administered six times weekly for two weeks, followed by twice weekly for another 22 weeks.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with chronic hepatitis B, thymosin alpha‑1 therapy had a significant effect on response when serum HBV-DNA was below 100 Meq/ml before treatment (p = 0.0063).

    In plain wordsIn people with hepatitis B given thymosin alpha‑1, response was linked to starting treatment with a low amount of virus.

    Peptide
    Thymosin alpha-1
    Outcome
    IncreaseTreatment effect in patients with pre-treatment HBV-DNA below 100 Meq/ml
    Study

    n: not reported in source

    Outcome group
    Antiviral activity · Infection
    Studied dose
    0.8 mg or 1.6 mg · two weeks six times weekly, then 22 weeks twice weeklyAs given in this study (human).

    Source sentences

    Summary
    Talpha1 therapy had a significant effect when, 1) transient acute exacerbation was present (p = 0.0029), 2) the serum HBV-DNA level was < 100 Meq/ml prior to the commencement of Talpha1 therapy (p = 0.0063).
    1 context sentence
    Summary · context
    Sixteen patients were randomly assigned into one of two groups, treated with 0.8 mg of Talpha1 (low dose group; n = 8) or 1.6 mg Talpha1 (high dose group; n = 8), administered six times weekly for two weeks, followed by twice weekly for another 22 weeks.

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, 08:55 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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