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Protocol Reference
Thymosin alpha-1 (thymalfasin)

Thymosin alpha-1 — hepatitis B trial protocols as reported

Summarise the administration schedules reported in randomised trials and meta-analyses of chronic hepatitis B.

Clinical TrialsReviewed September 1, 2026

Research Context

Source of this information
Thymalfasin is approved in several countries outside the United States for this indication, so published protocols exist.
Evidence level
Grade B — randomised trials and meta-analyses with variable methodological quality
Population studied
Adults with chronic hepatitis B in the trials summarised by published meta-analyses.
Duration studied
Commonly six months of treatment with follow-up in the reported trials.
Route reported
Subcutaneous injection, typically twice weekly in reported trials

Protocol as Reported

  • 01Reported trials administered a fixed subcutaneous dose twice weekly over approximately six months.
  • 02Virological and biochemical response were assessed during treatment and at follow-up after treatment ended.
  • 03Some trials combined thymalfasin with antiviral therapy; others compared it with interferon.

Adverse Events Reported

  • Injection-site reactions were the most frequently reported effect.
  • Rash and transient laboratory abnormalities have been reported.
  • Immune stimulation is a theoretical concern in autoimmune disease.

Limitations

  • Trial quality and reporting standards vary considerably between regions.
  • The compound is not FDA approved in the United States, so no US label defines a protocol.
  • Protocols for immune indications do not transfer to wellness or performance use.

Sources

  • Systematic review

    Thymosin alpha-1 in chronic hepatitis B: meta-analysis of randomised trials

    View Study
  • Regulatory document

    Registered thymalfasin trials

    View Clinical Trial
Read the full Thymosin Alpha-1 research guide
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