Efficacy of thymosin alpha-1 and interferon alpha in treatment of chronic viral hepatitis B: a randomized controlled study.

You J, Zhuang L, Cheng HY, Yan SM, Yu L, Huang JH, Tang BZ, Huang ML, Ma YL, Chongsuvivatwong V, Sriplung H, Geater A, Qiao YW, Wu RX

World journal of gastroenterology1 Nov 2006Cited by 32 (Europe PMC)

PMID17075991PMCIDPMC4125683DOI10.3748/wjg.v12.i41.6715PepBankPUB-17075991

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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 study9

9 results from studies that gave the peptide. 9 results from people.

01HumanRandomized controlled trialEfficacy outcome
In HBeAg-positive adults with chronic hepatitis B, the complete response rate at the end of treatment did not differ significantly between thymosin alpha‑1 and interferon alpha (31.0% vs 45.5%, P>0.05).
In plain wordsIn adults with HBeAg-positive chronic hepatitis B, thymosin alpha‑1 and interferon alpha did not differ significantly in complete response at the end of treatment.
Peptide
Thymosin alpha-1
Outcome
No significant changeComplete response at end of treatment
Study
n = 62
Comparator
Interferon alpha
Outcome group
Antiviral activity · Liver
Studied dose
1.6 mg twice a week · subcutaneous · 6 monthsAs given in this study (human).
Measurements
Complete response
31%
T-alpha1 group, end of treatment
Complete response
45.5%
IFN-alpha group, end of treatment
Source sentences
Summary
At the end of treatment, complete response, which was defined as alanine aminotransferase (ALT) normalization and HBV DNA and HBeAg loss, occurred in 9 of 29 (31.0%) patients in the T-alpha1 group and in 15 of 33 (45.5%) patients in the IFN-alpha group (chi2=1.36, P>0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
The patients in group A received subcutaneous injection of 1.6 mg thymosin-alpha1, twice a week (T-alpha1 group) for six months, and the patients in group B received 5 MU interferon alpha (IFN-alpha) each day for fifteen days, then three times weekly (IFN-alpha group) for six months.
Report a problemFND-1707599101
02HumanRandomized controlled trialEfficacy outcome
In HBeAg-positive adults with chronic hepatitis B, the complete response rate after 6 months of follow-up did not differ significantly between thymosin alpha‑1 and interferon alpha (48.3% vs 27.3%, P>0.05).
In plain wordsIn adults with HBeAg-positive chronic hepatitis B, thymosin alpha‑1 and interferon alpha did not differ significantly in complete response after follow-up.
Peptide
Thymosin alpha-1
Outcome
No significant changeComplete response after 6 months of follow-up
Study
n = 62
Comparator
Interferon alpha
Outcome group
Antiviral activity · Liver
Studied dose
1.6 mg twice a week · subcutaneous · 6 monthsAs given in this study (human).
Measurements
Complete response
48.3%
T-alpha1 group, follow-up
Complete response
27.3%
IFN-alpha group, follow-up
Source sentences
Summary
After a follow-up period of six months, a complete response was observed in 14 of 29 (48.3%) patients in the T-alpha1 group and in 9 of 33 (27.3%) patients in the IFN-alpha group (chi2=2.93, P>0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
The patients in group A received subcutaneous injection of 1.6 mg thymosin-alpha1, twice a week (T-alpha1 group) for six months, and the patients in group B received 5 MU interferon alpha (IFN-alpha) each day for fifteen days, then three times weekly (IFN-alpha group) for six months.
Report a problemFND-1707599102
03HumanRandomized controlled trialEfficacy outcome
In HBeAg-positive adults with chronic hepatitis B, the proportion with ALT normalization at the end of follow-up was significantly higher with thymosin alpha‑1 than with interferon alpha, with three-fold higher odds.
In plain wordsIn adults with HBeAg-positive chronic hepatitis B, more people had normal liver enzyme levels after follow-up with thymosin alpha‑1 than with interferon alpha.
Peptide
Thymosin alpha-1
Outcome
IncreaseALT normalization at end of follow-up versus interferon alpha
Study
n = 62
Comparator
Interferon alpha
Outcome group
Liver fat and liver function · Liver
Studied dose
1.6 mg twice a week · subcutaneous · 6 monthsAs given in this study (human).
Source sentences
Summary
By the end of the follow-up period, the proportions of ALT normalization and negative HBV DNA in the T-alpha1 group were significantly higher than those in the IFN-alpha and HC groups. The odds of ALT normalization and negative HBV DNA at the end of the follow-up was three-fold higher in the T-alpha…
1 context sentence(design, population, supporting numbers)
Summary · context
The patients in group A received subcutaneous injection of 1.6 mg thymosin-alpha1, twice a week (T-alpha1 group) for six months, and the patients in group B received 5 MU interferon alpha (IFN-alpha) each day for fifteen days, then three times weekly (IFN-alpha group) for six months.
Report a problemFND-1707599105
04HumanRandomized controlled trialEfficacy outcome
In HBeAg-positive adults with chronic hepatitis B, the proportion with negative HBV DNA at the end of follow-up was significantly higher with thymosin alpha‑1 than with interferon alpha, with three-fold higher odds.
In plain wordsIn adults with HBeAg-positive chronic hepatitis B, more people had no detectable HBV DNA after follow-up with thymosin alpha‑1 than with interferon alpha.
Peptide
Thymosin alpha-1
Outcome
IncreaseNegative HBV DNA at end of follow-up versus interferon alpha
Study
n = 62
Comparator
Interferon alpha
Outcome group
Antiviral activity · Liver
Studied dose
1.6 mg twice a week · subcutaneous · 6 monthsAs given in this study (human).
Source sentences
Summary
By the end of the follow-up period, the proportions of ALT normalization and negative HBV DNA in the T-alpha1 group were significantly higher than those in the IFN-alpha and HC groups. The odds of ALT normalization and negative HBV DNA at the end of the follow-up was three-fold higher in the T-alpha…
1 context sentence(design, population, supporting numbers)
Summary · context
The patients in group A received subcutaneous injection of 1.6 mg thymosin-alpha1, twice a week (T-alpha1 group) for six months, and the patients in group B received 5 MU interferon alpha (IFN-alpha) each day for fifteen days, then three times weekly (IFN-alpha group) for six months.
Report a problemFND-1707599106
05HumanRandomized controlled trialSafety outcome
In adults with chronic hepatitis B, thymosin alpha‑1 was well tolerated by all patients and no side effects appeared in the thymosin alpha‑1 group.
In plain wordsIn adults with chronic hepatitis B, all patients given thymosin alpha‑1 tolerated it well and none reported side effects.
Peptide
Thymosin alpha-1
Outcome
No significant changeTolerability and side effects
Study
n = 29
Outcome group
Adverse events · Liver
Studied dose
1.6 mg twice a week · subcutaneous · 6 monthsAs given in this study (human).
Source sentences
Summary
T-alpha1 was well tolerated by all patients, and no side effects appeared in T-alpha1 group.
1 context sentence(design, population, supporting numbers)
Summary · context
The patients in group A received subcutaneous injection of 1.6 mg thymosin-alpha1, twice a week (T-alpha1 group) for six months, and the patients in group B received 5 MU interferon alpha (IFN-alpha) each day for fifteen days, then three times weekly (IFN-alpha group) for six months.
Report a problemFND-1707599109
06HumanNon-randomized trialEfficacy outcome
In HBeAg-positive adults with chronic hepatitis B, the complete response rate at the end of follow-up was significantly higher with thymosin alpha‑1 than in the untreated historical control group (14 of 29 vs 1 of 30, P<0.001).
In plain wordsIn adults with HBeAg-positive chronic hepatitis B, complete response after follow-up was more frequent with thymosin alpha‑1 than in an untreated historical group.
Peptide
Thymosin alpha-1
Outcome
IncreaseComplete response versus historical control at end of follow-up
Study
n = 59
Comparator
Historical control (untreated)
Outcome group
Antiviral activity · Liver
Studied dose
1.6 mg twice a week · subcutaneous · 6 monthsAs given in this study (human).
Source sentences
Summary
Compared with the results observed in the historical control (HC) group untreated with IFN-alpha which was followed up for 12 mo, the rate of complete response was significantly higher in IFN-alpha group at the end of therapy (1 of 30 vs 15 of 33, chi2=14.72, P<0.001) and in the T-alpha1 group at th…
2 context sentences(design, population, supporting numbers)
Summary · context
The results between two groups treated with and the group untreated with IFN-alpha which was followed up for 12 mo (historical control group consisting of 30 patients) were compared, and three groups were comparable between each other (P>0.05) at baseline (age, sex, clinical history, biochemical, an…
Summary · context
The patients in group A received subcutaneous injection of 1.6 mg thymosin-alpha1, twice a week (T-alpha1 group) for six months, and the patients in group B received 5 MU interferon alpha (IFN-alpha) each day for fifteen days, then three times weekly (IFN-alpha group) for six months.
Report a problemFND-1707599103
07HumanNon-randomized trialEfficacy outcome
In HBeAg-positive adults with chronic hepatitis B, the proportion with ALT normalization at the end of follow-up was significantly higher with thymosin alpha‑1 than in the untreated historical control group.
In plain wordsIn adults with HBeAg-positive chronic hepatitis B, more people had normal liver enzymes after follow-up with thymosin alpha‑1 than in untreated historical controls.
Peptide
Thymosin alpha-1
Outcome
IncreaseALT normalization at end of follow-up versus historical control
Study
n = 59
Comparator
Historical control (untreated)
Outcome group
Liver fat and liver function · Liver
Studied dose
1.6 mg twice a week · subcutaneous · 6 monthsAs given in this study (human).
Source sentences
Summary
By the end of the follow-up period, the proportions of ALT normalization and negative HBV DNA in the T-alpha1 group were significantly higher than those in the IFN-alpha and HC groups.
2 context sentences(design, population, supporting numbers)
Summary · context
The results between two groups treated with and the group untreated with IFN-alpha which was followed up for 12 mo (historical control group consisting of 30 patients) were compared, and three groups were comparable between each other (P>0.05) at baseline (age, sex, clinical history, biochemical, an…
Summary · context
The patients in group A received subcutaneous injection of 1.6 mg thymosin-alpha1, twice a week (T-alpha1 group) for six months, and the patients in group B received 5 MU interferon alpha (IFN-alpha) each day for fifteen days, then three times weekly (IFN-alpha group) for six months.
Report a problemFND-1707599107
08HumanNon-randomized trialEfficacy outcome
In HBeAg-positive adults with chronic hepatitis B, the proportion with negative HBV DNA at the end of follow-up was significantly higher with thymosin alpha‑1 than in the untreated historical control group.
In plain wordsIn adults with HBeAg-positive chronic hepatitis B, more people had no detectable HBV DNA after follow-up with thymosin alpha‑1 than in untreated historical controls.
Peptide
Thymosin alpha-1
Outcome
IncreaseNegative HBV DNA at end of follow-up versus historical control
Study
n = 59
Comparator
Historical control (untreated)
Outcome group
Antiviral activity · Liver
Studied dose
1.6 mg twice a week · subcutaneous · 6 monthsAs given in this study (human).
Source sentences
Summary
By the end of the follow-up period, the proportions of ALT normalization and negative HBV DNA in the T-alpha1 group were significantly higher than those in the IFN-alpha and HC groups.
2 context sentences(design, population, supporting numbers)
Summary · context
The results between two groups treated with and the group untreated with IFN-alpha which was followed up for 12 mo (historical control group consisting of 30 patients) were compared, and three groups were comparable between each other (P>0.05) at baseline (age, sex, clinical history, biochemical, an…
Summary · context
The patients in group A received subcutaneous injection of 1.6 mg thymosin-alpha1, twice a week (T-alpha1 group) for six months, and the patients in group B received 5 MU interferon alpha (IFN-alpha) each day for fifteen days, then three times weekly (IFN-alpha group) for six months.
Report a problemFND-1707599108
09HumanNon-randomized trialEfficacy outcome
In adults with chronic hepatitis B, the AUC of negative HBV DNA and HBeAg was 34%, 17%, 31% and 19% smaller in the thymosin alpha‑1 and interferon alpha groups than in the historical control group.
In plain wordsIn adults with chronic hepatitis B, the area-under-curve measure for negative HBV DNA and HBeAg was smaller in treated groups than in untreated historical controls.
Peptide
Thymosin alpha-1
Outcome
DecreaseAUC of negative HBV DNA and HBeAg versus historical control
Study
n: not reported in source
Comparator
Historical control (untreated)
Outcome group
Antiviral activity · Liver
Studied dose
1.6 mg twice a week · subcutaneous · 6 monthsAs given in this study (human).
Source sentences
Summary
In T-alpha1 and IFN-alpha treatment groups, the area under (the plasma concentration time) curve (AUC) of negative HBV DNA and HBeAg was 34%, 17%, 31% and 19% smaller than that in the HC group.
1 context sentence(design, population, supporting numbers)
Summary · context
The patients in group A received subcutaneous injection of 1.6 mg thymosin-alpha1, twice a week (T-alpha1 group) for six months, and the patients in group B received 5 MU interferon alpha (IFN-alpha) each day for fifteen days, then three times weekly (IFN-alpha group) for six months.
Report a problemFND-1707599104

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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