A randomized controlled trial of thymosin-alpha1 versus interferon alfa treatment in patients with hepatitis B e antigen antibody--and hepatitis B virus DNA--positive chronic hepatitis B.

Andreone P, Cursaro C, Gramenzi A, Zavagliz C, Rezakovic I, Altomare E, Severini R, Franzone JS, Albano O, Ideo G, Bernardi M, Gasbarrini G

Hepatology (Baltimore, Md.)1 Oct 1996Cited by 56 (Europe PMC)

PMID8855175DOI10.1002/hep.510240404PepBankPUB-08855175

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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 study5

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

01HumanRandomized controlled trialEfficacy outcome
In anti-HBe-positive chronic hepatitis B, complete response at end of treatment was 29.4% with T-alpha1 and 43.8% with interferon alfa, not a significant difference.
In plain wordsIn people with chronic hepatitis B, complete response at the end of treatment was 29.4% with thymosin-alpha1 and 43.8% with interferon, not a significant difference.
Peptide
Thymosin alpha-1
Outcome
No significant changeComplete response at end of treatment
Study
n = 33
Comparator
Interferon alfa
Outcome group
Antiviral activity · Liver
Studied dose
900 microg/m2 twice weekly · 6 monthsAs given in this study (human).
Measurements
Complete response
29.4%
T-alpha1
Complete response
43.8%
IFN-alpha
Source sentences
Summary
At the end of treatment, complete response (defined as ALT normalization and HBV-DNA loss) occurred in 5 of 17 (29.4%) in the T-alpha1 group and in 7 of 16 (43.8%) in the IFN-alpha group (P = not significant).
1 context sentence(design, population, supporting numbers)
Summary · context
Thirty-three patients were randomly assigned to receive either T-alpha1 900 microg/m2 body surface area twice weekly (17 patients) or 5 MU of interferon alfa (IFN-alpha) three times weekly (16 patients) for 6 months.
Report a problemFND-0885517501
02HumanRandomized controlled trialEfficacy outcome
In anti-HBe-positive chronic hepatitis B, complete response after 6 months of follow-up was 41.2% with T-alpha1 and 25% with interferon alfa, not a significant difference.
In plain wordsIn people with chronic hepatitis B, complete response 6 months after treatment was 41.2% with thymosin-alpha1 and 25% with interferon, not a significant difference.
Peptide
Thymosin alpha-1
Outcome
No significant changeComplete response after 6 months of follow-up
Study
n = 33
Comparator
Interferon alfa
Outcome group
Antiviral activity · Liver
Studied dose
900 microg/m2 twice weekly · 6 monthsAs given in this study (human).
Measurements
Complete response
41.2%
T-alpha1
Complete response
25%
IFN-alpha
Source sentences
Summary
After a follow-up period of 6 months, a complete response was observed in 7 of 17 (41.2%) in the T-alpha1 group and in 4 of 16 (25%) in the IFN-alpha group (P = n.s.).
1 context sentence(design, population, supporting numbers)
Summary · context
Thirty-three patients were randomly assigned to receive either T-alpha1 900 microg/m2 body surface area twice weekly (17 patients) or 5 MU of interferon alfa (IFN-alpha) three times weekly (16 patients) for 6 months.
Report a problemFND-0885517502
03HumanRandomized controlled trialSafety outcome
In anti-HBe-positive chronic hepatitis B, T-alpha1 was well tolerated by all patients, unlike interferon alfa.
In plain wordsIn people with chronic hepatitis B, thymosin-alpha1 was well tolerated by all patients, unlike interferon.
Peptide
Thymosin alpha-1
Outcome
No significant changeTolerability versus interferon alfa
Study
n = 33
Comparator
Interferon alfa
Outcome group
Adverse events · Whole body
Studied dose
900 microg/m2 twice weekly · 6 monthsAs given in this study (human).
Source sentences
Summary
Unlike IFN-alpha, T-alpha1 was well tolerated by all patients.
1 context sentence(design, population, supporting numbers)
Summary · context
Thirty-three patients were randomly assigned to receive either T-alpha1 900 microg/m2 body surface area twice weekly (17 patients) or 5 MU of interferon alfa (IFN-alpha) three times weekly (16 patients) for 6 months.
Report a problemFND-0885517504
04HumanRandomized controlled trialSafety outcome
In anti-HBe-positive chronic hepatitis B, the only side effect with T-alpha1, reported by some patients, was local discomfort at injection sites.
In plain wordsIn people with chronic hepatitis B, the only side effect of thymosin-alpha1, seen in some, was discomfort where the injection was given.
Peptide
Thymosin alpha-1
Outcome
Not applicableLocal discomfort at injection sites
Study
n = 33
Outcome group
Adverse events · Whole body
Studied dose
900 microg/m2 twice weekly · 6 monthsAs given in this study (human).
Source sentences
Summary
The only side effect, reported by some, was local discomfort at injection sites.
1 context sentence(design, population, supporting numbers)
Summary · context
Thirty-three patients were randomly assigned to receive either T-alpha1 900 microg/m2 body surface area twice weekly (17 patients) or 5 MU of interferon alfa (IFN-alpha) three times weekly (16 patients) for 6 months.
Report a problemFND-0885517505
05HumanNon-randomized trialEfficacy outcome
In anti-HBe-positive chronic hepatitis B, complete response at end of follow-up was significantly higher with T-alpha1 (7 of 17) than in 15 never-treated patients (1 of 15).
In plain wordsIn people with chronic hepatitis B, complete response was more common with thymosin-alpha1 (7 of 17) than in untreated patients (1 of 15).
Peptide
Thymosin alpha-1
Outcome
IncreaseComplete response at end of follow-up versus never-treated patients
Study
n = 32
Comparator
Patients never treated with IFN-alpha
Outcome group
Antiviral activity · Liver
Studied dose
900 microg/m2 twice weekly · 6 monthsAs given in this study (human).
Source sentences
Summary
Compared with the results observed in a group of 15 patients never treated with IFN-alpha and followed for 12 months
2 context sentences(design, population, supporting numbers)
Summary · context
in the T-alpha1 group at the end of follow-up (1 of 15 vs. 7 of 17, respectively; P < .05
Summary · context
Thirty-three patients were randomly assigned to receive either T-alpha1 900 microg/m2 body surface area twice weekly (17 patients) or 5 MU of interferon alfa (IFN-alpha) three times weekly (16 patients) for 6 months.
Report a problemFND-0885517503

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 1/2NCT02646189

Therapeutic Safety and Efficacy of REP 2139 (REP 9AC') in HBV Infected Patients

Replicor Inc.n = 12Aug 2011 to Aug 2013

Hepatitis B, Chronic

Trial page ClinicalTrials.govUpdated 5 Jan 2016

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.

Version 3Current
9 Oct 2026, 18:17 UTC
Study results updated
Version 2
9 Oct 2026, 03:03 UTC
Study data updated · source update from Europe PMC
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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