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Study · Randomized controlled trial · n = 109 · 1998

6 results

Combination therapy with thymosin alpha1 and interferon for the treatment of chronic hepatitis C infection: a randomized, placebo-controlled double-blind trial.

Sherman KE, Sjogren M, Creager RL, Damiano MA, Freeman S, Lewey S, Davis D, Root S, Weber FL, Ishak KG, Goodman ZD

Hepatology (Baltimore, Md.)1 Apr 1998Cited by 53 (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 study6

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In chronic hepatitis C, end-of-treatment biochemical response was higher with thymosin alpha1 plus interferon (37.1%) than with interferon alone (16.2%).

    In plain wordsIn people with chronic hepatitis C, thymosin alpha1 plus interferon gave more normal liver enzymes at treatment end than interferon alone (37.1% versus 16.2%).

    Outcome
    IncreaseEnd-of-treatment biochemical response
    Study

    n = 109

    Comparator
    Interferon alone
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    1.6 mg twice weekly · subcutaneous · 26 weeksAs given in this study (human).

    Measurements

    End-of-treatment biochemical response
    37.1%
    IFN/TA1
    End-of-treatment biochemical response
    16.2%
    IFN alone

    Source sentences

    Summary
    End-of-treatment biochemical response was seen in 37.1% of patients treated with combination therapy, 16.2% of patients treated with IFN alone, and 2.7% of untreated controls by intent-to-treat analysis (IFN/TA1 vs. IFN, chi2 = 4.05, P = .04).
    2 context sentences
    Summary · context
    We performed a randomized, double-blind, placebo-controlled trial to compare the biological activity of a combination TA1 and IFN with that seen for IFN alone in patients with chronic hepatitis C infection.
    Summary · context
    One hundred nine patients were randomized for intention to treat and received 1.6 mg of TA1 subcutaneously twice weekly and 3 MU of IFN three times weekly; 3 MU of IFN three times weekly and placebo TA1; or placebo for both agents.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In chronic hepatitis C, HCV RNA clearance was seen in 37.1% with thymosin alpha1 plus interferon and 18.9% with interferon alone.

    In plain wordsIn people with chronic hepatitis C, thymosin alpha1 plus interferon cleared the virus in more people than interferon alone (37.1% versus 18.9%).

    Outcome
    IncreaseHCV RNA clearance
    Study

    n = 109

    Comparator
    Interferon alone
    Outcome group
    Antiviral activity · Liver
    Studied dose
    1.6 mg twice weekly · subcutaneous · 26 weeksAs given in this study (human).

    Measurements

    HCV RNA clearance
    37.1%
    IFN/TA1
    HCV RNA clearance
    18.9%
    IFN alone

    Source sentences

    Summary
    HCV RNA clearance was seen in 37.1% of IFN/TA1-treated patients and 18.9% of IFN-treated subjects.
    2 context sentences
    Summary · context
    We performed a randomized, double-blind, placebo-controlled trial to compare the biological activity of a combination TA1 and IFN with that seen for IFN alone in patients with chronic hepatitis C infection.
    Summary · context
    One hundred nine patients were randomized for intention to treat and received 1.6 mg of TA1 subcutaneously twice weekly and 3 MU of IFN three times weekly; 3 MU of IFN three times weekly and placebo TA1; or placebo for both agents.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In chronic hepatitis C, mean HCV RNA titers were significantly lower than baseline at weeks 8, 16 and 24 with thymosin alpha1 plus interferon but not in the other arms.

    In plain wordsIn people with chronic hepatitis C, virus levels fell below baseline with thymosin alpha1 plus interferon, but not in the interferon-alone or placebo groups.

    Outcome
    DecreaseMean HCV RNA titer versus baseline
    Study

    n = 109

    Comparator
    Baseline
    Outcome group
    Antiviral activity · Liver
    Studied dose
    1.6 mg twice weekly · subcutaneous · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    Mean HCV RNA titers were significantly lower than baseline at weeks 8, 16, and 24 after drug initiation among patients treated with IFN/TA1 but not in the other treatment arms.
    2 context sentences
    Summary · context
    We performed a randomized, double-blind, placebo-controlled trial to compare the biological activity of a combination TA1 and IFN with that seen for IFN alone in patients with chronic hepatitis C infection.
    Summary · context
    One hundred nine patients were randomized for intention to treat and received 1.6 mg of TA1 subcutaneously twice weekly and 3 MU of IFN three times weekly; 3 MU of IFN three times weekly and placebo TA1; or placebo for both agents.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In chronic hepatitis C, histological improvement occurred more often with thymosin alpha1 plus interferon than in the comparison groups.

    In plain wordsIn people with chronic hepatitis C, liver tissue improved more often with thymosin alpha1 plus interferon than with interferon alone or placebo.

    Outcome
    IncreaseHistological improvement (HAI decrease of more than two points)
    Study

    n = 109

    Comparator
    Interferon alone and placebo
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    1.6 mg twice weekly · subcutaneous · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    Histological improvement, as evidenced by a decrease in HAI of more than two points, occurred in the combination therapy arm more frequently than in comparison groups.
    2 context sentences
    Summary · context
    We performed a randomized, double-blind, placebo-controlled trial to compare the biological activity of a combination TA1 and IFN with that seen for IFN alone in patients with chronic hepatitis C infection.
    Summary · context
    One hundred nine patients were randomized for intention to treat and received 1.6 mg of TA1 subcutaneously twice weekly and 3 MU of IFN three times weekly; 3 MU of IFN three times weekly and placebo TA1; or placebo for both agents.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In chronic hepatitis C, cumulative sustained biochemical response was 14.2% with thymosin alpha1 plus interferon and 8.1% with interferon alone.

    In plain wordsIn people with chronic hepatitis C, lasting normal liver enzymes were seen in 14.2% with thymosin alpha1 plus interferon and 8.1% with interferon alone.

    Outcome
    IncreaseCumulative sustained biochemical response
    Study

    n = 109

    Comparator
    Interferon alone
    Outcome group
    Liver fat and liver function · Liver
    Studied dose
    1.6 mg twice weekly · subcutaneous · 26 weeksAs given in this study (human).

    Measurements

    Cumulative sustained biochemical response
    14.2%
    IFN/TA1
    Cumulative sustained biochemical response
    8.1%
    IFN alone

    Source sentences

    Summary
    Cumulative sustained biochemical responses were 14.2% and 8.1% in the IFN/TA1 and IFN arms, respectively, based on an intention-to-treat model.
    2 context sentences
    Summary · context
    We performed a randomized, double-blind, placebo-controlled trial to compare the biological activity of a combination TA1 and IFN with that seen for IFN alone in patients with chronic hepatitis C infection.
    Summary · context
    One hundred nine patients were randomized for intention to treat and received 1.6 mg of TA1 subcutaneously twice weekly and 3 MU of IFN three times weekly; 3 MU of IFN three times weekly and placebo TA1; or placebo for both agents.

Studies that did not test the peptide alone1

In this study, Thymosin alpha-1 was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Thymosin alpha-1.

  1. 06HumanNot a test of Thymosin alpha-1 aloneRandomized controlled trialEfficacy outcome

    In chronic hepatitis C, end-of-treatment biochemical response was 37.1% with thymosin alpha1 plus interferon and 2.7% in untreated controls.

    In plain wordsIn people with chronic hepatitis C, thymosin alpha1 plus interferon gave more normal liver enzymes at the end of treatment than placebo (37.1% versus 2.7%).

    Outcome
    IncreaseEnd-of-treatment biochemical response versus placebo
    Study

    n = 109

    Comparator
    Placebo
    Outcome group
    Liver fat and liver function · Liver

    Measurements

    End-of-treatment biochemical response
    37.1%
    IFN/TA1
    End-of-treatment biochemical response
    2.7%
    untreated controls

    Source sentences

    Summary
    End-of-treatment biochemical response was seen in 37.1% of patients treated with combination therapy, 16.2% of patients treated with IFN alone, and 2.7% of untreated controls by intent-to-treat analysis (IFN/TA1 vs. IFN, chi2 = 4.05, P = .04).
    2 context sentences
    Summary · context
    We performed a randomized, double-blind, placebo-controlled trial to compare the biological activity of a combination TA1 and IFN with that seen for IFN alone in patients with chronic hepatitis C infection.
    Summary · context
    One hundred nine patients were randomized for intention to treat and received 1.6 mg of TA1 subcutaneously twice weekly and 3 MU of IFN three times weekly; 3 MU of IFN three times weekly and placebo TA1; or placebo for both agents.

    In this study, Thymosin alpha-1 was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Thymosin alpha-1.

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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