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Study · Randomized controlled trial · n = 44 · 2000

7 results

A randomized, controlled study of thymosin-alpha1 therapy in patients with anti-HBe, HBV-DNA-positive chronic hepatitis B.

Zavaglia C, Severini R, Tinelli C, Franzone JS, Airoldi A, Tempini S, Bettale G, Ideo G

Digestive diseases and sciences1 Apr 2000Cited by 27 (Europe PMC)

PMID10759236 (opens in a new tab)DOI10.1023/a:1005431323945 (opens in a new tab)PepBankPUB-10759236
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 study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In HBV carriers who were anti-HBe- and HBV-DNA-positive, thymosin-alpha1 treatment had no side effects.

    In plain wordsIn people with chronic hepatitis B, thymosin-alpha1 treatment caused no side effects.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeSide effects
    Study

    n = 44

    Comparator
    No treatment
    Outcome group
    Adverse events · Whole body
    Studied dose
    900 microg/m2 twice a week · six monthsAs given in this study (human).

    Source sentences

    Summary
    Thymosin-alpha1 treatment had no side effects.
    1 context sentence
    Summary · context
    Forty-four chronic hepatitis B virus (HBV) carriers, who were anti-HBe- and HBV-DNA-positive, were randomized, with stratification for the presence of cirrhosis at baseline liver biopsy, to receive either thymosin-alpha1 at a dose of 900 microg/m2 twice a week for six months or no treatment.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In anti-HBe-positive chronic hepatitis B, HBV-DNA negativity with ALT normalization six months after therapy occurred in 14% of treated and 4.5% of control patients; the authors concluded that response rate did not increase.

    In plain wordsIn people with chronic hepatitis B, virus clearance with normal liver enzymes was seen in 14% with thymosin-alpha1 and 4.5% with no treatment.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeHBV-DNA negativity with ALT normalization six months after therapy
    Study

    n = 44

    Comparator
    No treatment
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    900 microg/m2 twice a week · six monthsAs given in this study (human).

    Measurements

    HBV-DNA negative and ALT normalized
    14%
    thymosin-alpha1
    HBV-DNA negative and ALT normalized
    4.5%
    control

    Source sentences

    Summary
    Six months after the end of the therapy, HBV-DNA was negative and ALT had normalized in 14% of treated cases and in 4.5% of control group
    2 context sentences
    Summary · context
    thymosin-alpha1 therapy alone does not increase the response rate
    Summary · context
    Forty-four chronic hepatitis B virus (HBV) carriers, who were anti-HBe- and HBV-DNA-positive, were randomized, with stratification for the presence of cirrhosis at baseline liver biopsy, to receive either thymosin-alpha1 at a dose of 900 microg/m2 twice a week for six months or no treatment.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In anti-HBe-positive chronic hepatitis B, IgM anti-HBc negativity six months after therapy occurred in 14% of treated and 4.5% of control patients.

    In plain wordsIn people with chronic hepatitis B, IgM anti-HBc became negative in 14% with thymosin-alpha1 and 4.5% with no treatment.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeIgM anti-HBc negativity six months after therapy
    Study

    n = 44

    Comparator
    No treatment
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    900 microg/m2 twice a week · six monthsAs given in this study (human).

    Measurements

    IgM anti-HBc negative
    14%
    thymosin-alpha1
    IgM anti-HBc negative
    4.5%
    control

    Source sentences

    Summary
    while IgM anti-HBc was negative (<0.200) in 14% of the treated patients and in 4.5% of the controls.
    1 context sentence
    Summary · context
    Forty-four chronic hepatitis B virus (HBV) carriers, who were anti-HBe- and HBV-DNA-positive, were randomized, with stratification for the presence of cirrhosis at baseline liver biopsy, to receive either thymosin-alpha1 at a dose of 900 microg/m2 twice a week for six months or no treatment.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In anti-HBe-positive chronic hepatitis B, hepatitis flares in the first year did not differ significantly between control (six) and treated patients (five).

    In plain wordsIn people with chronic hepatitis B, the number of hepatitis flares in the first year was not significantly different with thymosin-alpha1 or no treatment.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeHepatitis flares in the first year
    Study

    n = 42

    Comparator
    No treatment
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    900 microg/m2 twice a week · six monthsAs given in this study (human).

    Source sentences

    Summary
    During the first year, there were six flares of hepatitis in the control group and five among the treated patients (P = NS), yielding a per year average of 0.3 and 0.23 flares per patient, respectively.
    1 context sentence
    Summary · context
    Forty-four chronic hepatitis B virus (HBV) carriers, who were anti-HBe- and HBV-DNA-positive, were randomized, with stratification for the presence of cirrhosis at baseline liver biopsy, to receive either thymosin-alpha1 at a dose of 900 microg/m2 twice a week for six months or no treatment.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In anti-HBe-positive chronic hepatitis B, none of the patients became HBsAg negative.

    In plain wordsIn people with chronic hepatitis B, none of the patients lost the hepatitis B surface antigen.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeHBsAg loss
    Study

    n = 42

    Outcome group
    Antiviral activity · Liver
    Studied dose
    900 microg/m2 twice a week · six monthsAs given in this study (human).

    Source sentences

    Summary
    None became HBsAg negative.
    1 context sentence
    Summary · context
    Forty-four chronic hepatitis B virus (HBV) carriers, who were anti-HBe- and HBV-DNA-positive, were randomized, with stratification for the presence of cirrhosis at baseline liver biopsy, to receive either thymosin-alpha1 at a dose of 900 microg/m2 twice a week for six months or no treatment.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In treated patients with anti-HBe-positive chronic hepatitis B, median ALT stayed significantly lower than pretreatment values during treatment and six months of follow-up.

    In plain wordsIn people with chronic hepatitis B given thymosin-alpha1, liver enzyme (ALT) levels stayed lower than before treatment during treatment and six months after.

    Peptide
    Thymosin alpha-1
    Outcome
    DecreaseMedian ALT versus pretreatment
    Study

    n: not reported in source

    Comparator
    Pretreatment values
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    900 microg/m2 twice a week · six monthsAs given in this study (human).

    Source sentences

    Summary
    Among the treated patients, the median ALT levels stayed significantly lower compared to the pretreatment values during the treatment period and six months of follow-up.
    1 context sentence
    Summary · context
    Forty-four chronic hepatitis B virus (HBV) carriers, who were anti-HBe- and HBV-DNA-positive, were randomized, with stratification for the presence of cirrhosis at baseline liver biopsy, to receive either thymosin-alpha1 at a dose of 900 microg/m2 twice a week for six months or no treatment.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In treated patients with anti-HBe-positive chronic hepatitis B, median IgM anti-HBc levels were lower than baseline 4-10 months after treatment started.

    In plain wordsIn people with chronic hepatitis B given thymosin-alpha1, IgM anti-HBc levels were lower than baseline 4-10 months after treatment started.

    Peptide
    Thymosin alpha-1
    Outcome
    DecreaseMedian IgM anti-HBc versus baseline
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    900 microg/m2 twice a week · six monthsAs given in this study (human).

    Source sentences

    Summary
    Among the treated patients, median IgM anti-HBc levels were low with respect to baseline values 4-10 months after treatment started.
    1 context sentence
    Summary · context
    Forty-four chronic hepatitis B virus (HBV) carriers, who were anti-HBe- and HBV-DNA-positive, were randomized, with stratification for the presence of cirrhosis at baseline liver biopsy, to receive either thymosin-alpha1 at a dose of 900 microg/m2 twice a week for six months or no treatment.

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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