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

W

Wen-hong Zhang

Status and phase

Unknown
Phase 4

Conditions

Chronic Hepatitis b

Treatments

Drug: Thymosin Alpha1
Drug: Entecavir

Study type

Interventional

Funder types

Other

Identifiers

NCT03448744
KY2016-219

Details and patient eligibility

About

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.

Full 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.

Enrollment

240 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • HBsAg positive and anti-HBs negative for more than 6 months
  • Being currently treated with ETV ≥1 years
  • HBeAg positivity and HBV DNA <60IU/mL with HBsAg <1500IU/mL and HBeAg <200S/CO at screening
  • ALT ≤5*ULN and total bilirubin ≤2*ULN
  • Age ≥ 18 yrs but ≤ 55 yrs
  • Written informed consent

Exclusion criteria

  • Patients who have contraindications for Thymosin alpha 1 in accordance with the approved summary of product characteristics
  • Patients with ALT > 5 x ULN or total bilirubin >2*ULN
  • Patients with evidence of hepatocellular carcinoma at screening
  • Patients with Child-Pugh score ≥7 or had a history of hepatic encephalopathy or esophageal pile or ascites
  • Patients with serological evidence of co-infection with hepatitis A virus, hepatitis C, human immunodeficiency virus or hepatitis D virus
  • Patients with a history of excessive drinking: male >40g/d,female >40g/d
  • Pregnant or breast-feeding women
  • A history of liver transplantation or planned for liver transplantation
  • Patients of autoimmune disease
  • Patients with other diseases combined
  • Patients with creatinine >1.5*ULN
  • Investigator considered not proper for participating the trial
  • Patients with other maliginant tumor

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

240 participants in 2 patient groups, including a placebo group

combiantion therapy group
Experimental group
Description:
thymosin alpha 1 (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
Treatment:
Drug: Entecavir
Drug: Thymosin Alpha1
entecavir group
Placebo Comparator group
Description:
ETV (0.5 mg orally, daily) at least for 72 weeks
Treatment:
Drug: Entecavir

Trial contacts and locations

1

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Central trial contact

Yiqi Yu, MD; Ying Yue, MD

Data sourced from clinicaltrials.gov

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