Overview

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

Status:
Unknown status
Trial end date:
2018-12-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Wen-hong Zhang
Treatments:
Entecavir
Thymalfasin
Criteria
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