drugset / Trial / NCT03448744

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

NCT03448744

Phase 4 Unknown 240 enrolled Wen-hong Zhang
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2017-10-25
Primary completion
2018-12-30
Completion
2018-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Entecavir Small molecule 0.5 mg Oral
Subject Thymalfasin Peptide 1.6 mg Subcutaneous