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Thymosin-alpha-1

Thymalfasin, Zadaxin, Thymosin α1

Quick Stats
Studies 759
Trials 63
Unknown PHASE4 INTERVENTIONAL NCT03448744

Efficacy and Safety of Combination Therapy of Thymalfasin and Entecavir in HBeAg-positive ETV-experienced Patients

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This is a multicenter, randomized, open-label control trial of two arms conducted at 10 centres in China.The aim was to investigate whether sequential combination therapy with Thymosin alpha 1 and entecavir is superior to continuous ETV monotherapy in HBeAg-positive chronic hepatitis B patients with previous long-term entecavir therapy (≥ 2 years), and to select the optimal patients who may benefit from sequential combination therapy.

Detailed Description

To investigate whether sequential combination therapy with Thymosin alpha 1 and entecavir is superior to continuous ETV monotherapy in HBeAg-positive chronic hepatitis B patients with previous long-term entecavir therapy (≥ 1 years), and to select the optimal patients who may benefit from sequential combination therapy.

Interventions

Name: Thymosin Alpha1
Type: DRUG
Description: Thymosin Alpha1 (1.6 mg subcutaneously injection twice a week) plus ETV (0.5 mg orally, daily) for 24 weeks, and followed by continuous ETV for at least 48 weeks
Name: Entecavir
Type: DRUG
Description: ETV (0.5 mg orally, daily) for 72 weeks

Primary Outcomes

Measure: HBeAg seroconversion rate at week 72
TimeFrame: week 72
Description: HBeAg seroconversion rate at week 72

Trial Information

NCT ID

NCT03448744

Status

Unknown

Study Type

INTERVENTIONAL

Phases

PHASE4

Sponsor

Wen-hong Zhang

Last Updated

December 15, 2025