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Study · Randomized controlled trial · n = 97 · 1999

3 results

Thymosin alpha1 treatment of chronic hepatitis B: results of a phase III multicentre, randomized, double-blind and placebo-controlled study.

Mutchnick MG, Lindsay KL, Schiff ER, Cummings GD, Appelman HD, Peleman RR, Silva M, Roach KC, Simmons F, Milstein S, Gordon SC, Ehrinpreis MN

Journal of viral hepatitis1 Sept 1999Cited by 41 (Europe PMC)

PMID10607256 (opens in a new tab)DOI10.1046/j.1365-2893.1999.00181.x (opens in a new tab)PepBankPUB-10607256
Publisher pagePubMedAsk about this study
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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 study3

3 results from studies that gave the peptide. 3 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In HBeAg-positive chronic hepatitis B, complete response occurred in 14% with Talpha1 and 4% with placebo (P = 0.084), a difference that was not significant.

    In plain wordsIn people with chronic hepatitis B, complete response was seen in 14% given thymosin alpha1 and 4% given placebo; the difference was not significant.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeComplete response at month 12
    Study

    n = 97

    Comparator
    Placebo
    Outcome group
    Antiviral activity · Liver
    Studied dose
    1.6 mg twice weekly · 6 monthsAs given in this study (human).

    Measurements

    Complete response
    14%
    Talpha1
    Complete response
    4%
    placebo

    Source sentences

    Summary
    A complete response to treatment, defined as a sustained serum HBV DNA-negative status (two negative results at least 3 months apart) during the 12-month study, with negative HBV DNA and HBeAg values at month 12, was seen in seven (14%) patients given Talpha1 and in two (4%) patients treated with placebo (P = 0.084).
    2 context sentences
    Summary · context
    Forty-nine patients received Talpha1 (1.6 mg) and 48 patients received placebo, twice weekly for 6 months, and were followed-up for an additional 6 months.
    Summary · context
    The aim of this study was to determine the efficacy of Talpha1 in a multicentre, placebo-controlled and double-blind study of 97 patients with serum hepatitis B virus (HBV) DNA- and hepatitis B e antigen (HBeAg)-positive CHB.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In HBeAg-positive chronic hepatitis B, delayed response occurred in 10% with Talpha1 and 8% with placebo; the authors did not confirm efficacy.

    In plain wordsIn people with chronic hepatitis B, delayed response was seen in 10% given thymosin alpha1 and 8% given placebo.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeDelayed response
    Study

    n = 97

    Comparator
    Placebo
    Outcome group
    Antiviral activity · Liver
    Studied dose
    1.6 mg twice weekly · 6 monthsAs given in this study (human).

    Measurements

    Delayed response
    10%
    Talpha1
    Delayed response
    8%
    placebo

    Source sentences

    Summary
    Five (10%) patients given Talpha1 and four (8%) patients given placebo exhibited a delayed response (defined as sustained serum HBV DNA negativity achieved after the 12-month study period with negative HBV DNA and HBeAg values at the last assessment).
    2 context sentences
    Summary · context
    These results do not confirm observations of treatment efficacy reported in other clinical studies.
    Summary · context
    The aim of this study was to determine the efficacy of Talpha1 in a multicentre, placebo-controlled and double-blind study of 97 patients with serum hepatitis B virus (HBV) DNA- and hepatitis B e antigen (HBeAg)-positive CHB.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In HBeAg-positive chronic hepatitis B, sustained loss of HBV DNA with a negative HBeAg occurred in 25% with Talpha1 and 13% with placebo (P < 0.11), a difference that was not significant.

    In plain wordsIn people with chronic hepatitis B, lasting loss of virus DNA was seen in 25% given thymosin alpha1 and 13% given placebo; not significant.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeSustained loss of HBV DNA with negative HBeAg
    Study

    n = 97

    Comparator
    Placebo
    Outcome group
    Antiviral activity · Liver
    Studied dose
    1.6 mg twice weekly · 6 monthsAs given in this study (human).

    Measurements

    Sustained loss of HBV DNA
    25%
    Talpha1
    Sustained loss of HBV DNA
    13%
    placebo

    Source sentences

    Summary
    A total of 12 (25%) patients given Talpha1 and six (13%) patients given placebo showed a sustained loss of HBV DNA with a negative HBeAg value during or following the 12-month study period (P < 0.11).
    2 context sentences
    Summary · context
    These results do not confirm observations of treatment efficacy reported in other clinical studies.
    Summary · context
    The aim of this study was to determine the efficacy of Talpha1 in a multicentre, placebo-controlled and double-blind study of 97 patients with serum hepatitis B virus (HBV) DNA- and hepatitis B e antigen (HBeAg)-positive CHB.

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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