The efficacy and safety of thymosin alpha-1 in Japanese patients with chronic hepatitis B; results from a randomized clinical trial.

Iino S, Toyota J, Kumada H, Kiyosawa K, Kakumu S, Sata M, Suzuki H, Martins EB

Journal of viral hepatitis1 May 2005Cited by 40 (Europe PMC)

PMID15850471DOI10.1111/j.1365-2893.2005.00633.xPepBankPUB-15850471

Publisher page PubMedAsk about this study

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.

01HumanRandomized controlled trialEfficacy outcome
In Japanese adults with chronic hepatitis B, thymosin alpha‑1 0.8 mg achieved efficacy rates similar to 1.6 mg.
In plain wordsIn Japanese adults with chronic hepatitis B, thymosin alpha‑1 0.8 mg gave similar response rates to the 1.6 mg dose.
Peptide
Thymosin alpha-1
Outcome
No significant changeEfficacy of 0.8 mg dose compared with 1.6 mg
Study
n = 316
Comparator
1.6 mg
Outcome group
Antiviral activity · Liver
Studied dose
0.8 mg · 24 weeksAs given in this study (human).
Source sentences
Summary
Patients in the 0.8-mg treatment group achieved similar efficacy rates
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 316 patients were randomized to receive either 0.8 or 1.6 mg of Talpha1 monotherapy for 24 weeks.
Report a problemFND-1585047104
02HumanRandomized controlled trialSafety outcome
In Japanese adults with chronic hepatitis B given thymosin alpha‑1 0.8 or 1.6 mg, all adverse drug reactions were mild and most involved fluctuation of liver enzymes.
In plain wordsIn Japanese adults with chronic hepatitis B given thymosin alpha‑1, all adverse drug reactions were mild and most involved changes in liver enzyme levels.
Peptide
Thymosin alpha-1
Outcome
Not applicableAdverse drug reactions
Study
n = 316
Outcome group
Adverse events · Whole body
Studied dose
0.8 mg or 1.6 mg · 24 weeksAs given in this study (human).
Source sentences
Summary
All adverse drug reactions were mild and most involved the fluctuation of liver enzymes
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 316 patients were randomized to receive either 0.8 or 1.6 mg of Talpha1 monotherapy for 24 weeks.
Report a problemFND-1585047106
03HumanRandomized controlled trialSafety outcome
In Japanese adults with chronic hepatitis B, adverse event incidence was similar in the 1.6 mg and 0.8 mg thymosin alpha‑1 groups.
In plain wordsIn Japanese adults with chronic hepatitis B, side effects occurred at a similar rate with thymosin alpha‑1 1.6 mg and 0.8 mg.
Peptide
Thymosin alpha-1
Outcome
No significant changeAdverse event incidence, 1.6 mg versus 0.8 mg
Study
n = 316
Comparator
0.8 mg versus 1.6 mg
Outcome group
Adverse events · Whole body
Studied dose
0.8 mg and 1.6 mg · 24 weeksAs given in this study (human).
Source sentences
Summary
Adverse event incidence was similar in the 1.6- and 0.8-mg treatment groups.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 316 patients were randomized to receive either 0.8 or 1.6 mg of Talpha1 monotherapy for 24 weeks.
Report a problemFND-1585047107
04HumanRandomized controlled trialEfficacy outcome
In Japanese adults with chronic hepatitis B, 36.4% of patients given thymosin alpha‑1 1.6 mg had ALT normalization at the end of the 72-week observation period.
In plain wordsIn Japanese adults with chronic hepatitis B, 36.4% of patients given thymosin alpha‑1 1.6 mg had normal liver enzyme levels 12 months after treatment ended.
Peptide
Thymosin alpha-1
Outcome
Not applicableALT normalization at 72 weeks
Study
n: not reported in source
Outcome group
Liver fat and liver function · Liver
Studied dose
1.6 mg · 24 weeksAs given in this study (human).
Measurements
ALT normalization
36.4%
1.6 mg group, week 72
Source sentences
Summary
At the end of the 72-week observation period (12 months after cessation of therapy), 36.4% of patients in the 1.6-mg treatment group achieved normalization of ALT, 30% achieved clearance of HBV-DNA by branched DNA vs 15% by transcription-mediated amplification, and 22.8% achieved clearance of HBe-antigen.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 316 patients were randomized to receive either 0.8 or 1.6 mg of Talpha1 monotherapy for 24 weeks.
Report a problemFND-1585047101
05HumanRandomized controlled trialEfficacy outcome
In Japanese adults with chronic hepatitis B, HBV-DNA clearance with thymosin alpha‑1 1.6 mg at 72 weeks was 30% by branched DNA and 15% by transcription-mediated amplification.
In plain wordsIn Japanese adults with chronic hepatitis B, HBV DNA cleared in 30% of those given thymosin alpha‑1 1.6 mg by one test, 15% by another.
Peptide
Thymosin alpha-1
Outcome
Not applicableHBV-DNA clearance at 72 weeks
Study
n: not reported in source
Outcome group
Antiviral activity · Liver
Studied dose
1.6 mg · 24 weeksAs given in this study (human).
Measurements
HBV-DNA clearance
30%
1.6 mg, branched DNA, week 72
HBV-DNA clearance
15%
1.6 mg, transcription-mediated amplification, week 72
Source sentences
Summary
At the end of the 72-week observation period (12 months after cessation of therapy), 36.4% of patients in the 1.6-mg treatment group achieved normalization of ALT, 30% achieved clearance of HBV-DNA by branched DNA vs 15% by transcription-mediated amplification, and 22.8% achieved clearance of HBe-antigen.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 316 patients were randomized to receive either 0.8 or 1.6 mg of Talpha1 monotherapy for 24 weeks.
Report a problemFND-1585047102
06HumanRandomized controlled trialEfficacy outcome
In Japanese adults with chronic hepatitis B, 22.8% of patients given thymosin alpha‑1 1.6 mg achieved HBe-antigen clearance at the end of the 72-week observation period.
In plain wordsIn Japanese adults with chronic hepatitis B, 22.8% of those given thymosin alpha‑1 1.6 mg cleared HBe-antigen 12 months after treatment ended.
Peptide
Thymosin alpha-1
Outcome
Not applicableHBe-antigen clearance at 72 weeks
Study
n: not reported in source
Outcome group
Antiviral activity · Liver
Studied dose
1.6 mg · 24 weeksAs given in this study (human).
Measurements
HBe-antigen clearance
22.8%
1.6 mg group, week 72
Source sentences
Summary
At the end of the 72-week observation period (12 months after cessation of therapy), 36.4% of patients in the 1.6-mg treatment group achieved normalization of ALT, 30% achieved clearance of HBV-DNA by branched DNA vs 15% by transcription-mediated amplification, and 22.8% achieved clearance of HBe-antigen.
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 316 patients were randomized to receive either 0.8 or 1.6 mg of Talpha1 monotherapy for 24 weeks.
Report a problemFND-1585047103
07HumanRandomized controlled trialEfficacy outcome
In Japanese adults with chronic hepatitis B and advanced fibrosis, 1.6 mg thymosin alpha‑1 gave a significantly better response rate than 0.8 mg (intragroup analysis; patients not stratified by liver biopsy).
In plain wordsIn Japanese adults with chronic hepatitis B and advanced fibrosis, the 1.6 mg dose gave a better response rate than the 0.8 mg dose.
Peptide
Thymosin alpha-1
Outcome
IncreaseResponse in patients with advanced fibrosis, 1.6 mg versus 0.8 mg
Study
n: not reported in source
Comparator
0.8 mg
Outcome group
Antiviral activity · Liver
Studied dose
1.6 mg · 24 weeksAs given in this study (human).
Source sentences
Summary
patients with advanced fibrosis demonstrated a significantly better response rate when treated with 1.6 mg of Talpha1 monotherapy vs 0.8 mg (as determined by intragroup analysis; patients were not stratified by liver biopsy).
1 context sentence(design, population, supporting numbers)
Summary · context
A total of 316 patients were randomized to receive either 0.8 or 1.6 mg of Talpha1 monotherapy for 24 weeks.
Report a problemFND-1585047105

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

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