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

Chronic Hepatitis b Clinical Trial

Official title:

A Multicenter, Randomized, Open-label Control Study to Evaluate Efficacy and Safety of Combination Therapy of Thymalfasin and Entecavir in HBeAg-positive ETV-experienced Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03448744
• Other study ID #: KY2016-219
• Status: Recruiting
• Phase: Phase 4
• First received: February 22, 2018
• Last updated: February 22, 2018
• Start date: October 25, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: February 2018
• Source: Huashan Hospital
• Contact: Yiqi Yu, MD
• Phone: +86-21-52888123
• Email: yyq19890619[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Thymosin Alpha1
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
• Entecavir
ETV (0.5 mg orally, daily) for 72 weeks

Locations

Country	Name	City	State
China	Huashan Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Wen-hong Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBeAg seroconversion rate at week 72	HBeAg seroconversion rate at week 72	week 72
Secondary	HBeAg seroconversion rate at week 48	HBeAg seroconversion rate at week 48	week 48
Secondary	HBsAg loss at week 48	HBsAg loss at week 48	week 48
Secondary	HBsAg loss at week 72	HBsAg loss at week 72	week 72
Secondary	HBsAg seroconversion at week 72	HBsAg seroconversion at week 72	week 72
Secondary	HBsAg seroconversion at week 48	HBsAg seroconversion at week 48	week 48
Secondary	HBsAg decline during the clinical trial	HBsAg decline during the clinical trial	week 12, weeek 24, week 36, week 48 and week 72
Secondary	ALT normalization rate at week 72	ALT normalization rate at week 72	week 72
Secondary	ALT normalization rate at week 48	ALT normalization rate at week 48	week 48
Secondary	Rate of HBV DNA <20IU/mL at week 72	Rate of HBV DNA <20IU/mL at week 72	week 72
Secondary	Rate of HBV DNA <20IU/mL at week 48	Rate of HBV DNA <20IU/mL at week 48	week 48