Status:
UNKNOWN
Efficacy and Safety of Combination Therapy of Thymalfasin and Entecavir in HBeAg-positive ETV-experienced Patients
Lead Sponsor:
Wen-hong Zhang
Conditions:
Chronic Hepatitis b
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
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 ent...
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-te...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2018
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT03448744
Start Date
October 25 2017
End Date
December 30 2018
Last Update
February 28 2018
Active Locations (1)
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1
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200040