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Study · Randomized controlled trial · n = 552 · 2012

4 results

Thymosin alpha-1 with peginterferon alfa-2a/ribavirin for chronic hepatitis C not responsive to IFN/ribavirin: an adjuvant role?

Ciancio A, Andreone P, Kaiser S, Mangia A, Milella M, Solà R, Pol S, Tsianos E, De Rosa A, Camerini R, McBeath R, Rizzetto M

Journal of viral hepatitis1 Jan 2012Cited by 14 (Europe PMC)

PMID22233415 (opens in a new tab)DOI10.1111/j.1365-2893.2011.01524.x (opens in a new tab)PepBankPUB-22233415
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 study4

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In hepatitis C patients not responding to peginterferon and ribavirin, sustained viral response rates in the intention-to-treat population were similar with thymosin alpha‑1 and placebo.

    In plain wordsIn hepatitis C patients who had not responded to earlier treatment, adding thymosin alpha‑1 to standard treatment gave a similar cure rate to adding placebo.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeSustained viral response (intention to treat)
    Study

    n = 552

    Comparator
    Placebo plus peginterferon alfa-2a and ribavirin
    Outcome group
    Antiviral activity · Infection
    Studied dose
    1.6 mg twice weekly · subcutaneous · 48 weeksAs given in this study (human).

    Measurements

    SVR rate
    12.7%
    thymosin alpha-1
    SVR rate
    10.5%
    placebo

    Source sentences

    Summary
    SVR rates in the intention to treat population were similar between thymosin alpha-1 and placebo (12.7%vs 10.5%; P = 0.407).
    1 context sentence
    Summary · context
    Patients (n = 552) with hepatitis C infections not responding to the combination of Peginterferon alfa-2a or 2b with ribavirin (RBV)were randomized to receive peginterferon alfa-2a 180 mg/week with RBV 800-1200 mg/daily plus either thymosin alpha-1 1.6 mg SC twice weekly (n = 275) or placebo (n = 277) for 48 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In hepatitis C patients not responding to earlier therapy, adding thymosin alpha‑1 did not increase the on-treatment HCV viral response.

    In plain wordsIn hepatitis C patients who had not responded to earlier treatment, adding thymosin alpha‑1 did not raise the viral response during treatment.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeOn-treatment HCV viral response
    Study

    n = 552

    Comparator
    Placebo plus peginterferon alfa-2a and ribavirin
    Outcome group
    Antiviral activity · Infection
    Studied dose
    1.6 mg twice weekly · subcutaneous · 48 weeksAs given in this study (human).

    Source sentences

    Summary
    The addition of thymosin alpha-1 to the standard of care did not increase the on-treatment HCV viral response.
    1 context sentence
    Summary · context
    Patients (n = 552) with hepatitis C infections not responding to the combination of Peginterferon alfa-2a or 2b with ribavirin (RBV)were randomized to receive peginterferon alfa-2a 180 mg/week with RBV 800-1200 mg/daily plus either thymosin alpha-1 1.6 mg SC twice weekly (n = 275) or placebo (n = 277) for 48 weeks.
  3. 03HumanRandomized controlled trialSafety outcome

    In hepatitis C patients, the incidence of adverse events did not differ significantly between thymosin alpha‑1 and placebo groups.

    In plain wordsIn hepatitis C patients, thymosin alpha‑1 and placebo groups had no significant difference in side effects.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeIncidence of adverse events
    Study

    n = 552

    Comparator
    Placebo plus peginterferon alfa-2a and ribavirin
    Outcome group
    Adverse events · Whole body
    Studied dose
    1.6 mg twice weekly · subcutaneous · 48 weeksAs given in this study (human).

    Source sentences

    Summary
    No significant difference was observed between treatment groups in the incidence of adverse events.
    1 context sentence
    Summary · context
    Patients (n = 552) with hepatitis C infections not responding to the combination of Peginterferon alfa-2a or 2b with ribavirin (RBV)were randomized to receive peginterferon alfa-2a 180 mg/week with RBV 800-1200 mg/daily plus either thymosin alpha-1 1.6 mg SC twice weekly (n = 275) or placebo (n = 277) for 48 weeks.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In hepatitis C patients who completed 48 weeks, the sustained viral response rate was higher with thymosin alpha‑1 than with placebo.

    In plain wordsIn hepatitis C patients who finished 48 weeks, the cure rate was higher with thymosin alpha‑1 added to standard treatment than with placebo added.

    Peptide
    Thymosin alpha-1
    Outcome
    IncreaseSustained viral response among patients completing 48 weeks
    Study

    n = 182

    Comparator
    Placebo plus peginterferon alfa-2a and ribavirin
    Outcome group
    Antiviral activity · Infection
    Studied dose
    1.6 mg twice weekly · subcutaneous · 48 weeksAs given in this study (human).

    Measurements

    SVR rate
    41%
    thymosin alpha-1 completers
    SVR rate
    26.3%
    placebo completers

    Source sentences

    Summary
    Among patients who completed all 48 weeks of therapy, the SVR rate was significantly higher in the thymosin alpha-1 group at 41.0% (34/83) compared with 26.3% (26/99) in the placebo group (P = 0.048).
    1 context sentence
    Summary · context
    Patients (n = 552) with hepatitis C infections not responding to the combination of Peginterferon alfa-2a or 2b with ribavirin (RBV)were randomized to receive peginterferon alfa-2a 180 mg/week with RBV 800-1200 mg/daily plus either thymosin alpha-1 1.6 mg SC twice weekly (n = 275) or placebo (n = 277) for 48 weeks.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3NCT01178996

Thymosin Alpha-1 in Combination With Peg-Interferon Alfa- 2a and Ribavirin for the Therapy of Chronic Hepatitis C Nonresponsive to the Combination of IFN and Ribavirin.

sigma-tau i.f.r. S.p.A.n = 552Dec 2004 to Jul 2009

Chronic Hepatitis C

Trial pageClinicalTrials.govUpdated 10 Aug 2010

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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