Antiviral Efficacy of the Combination Treatment With Poly IC and Entecavir for Chronic Hepatitis B

Chronic Hepatitis B Clinical Trial

Official title:

Comparison of Antiviral Efficacy of Entecavir Monotherapy and Combination Treatment With Poly IC for Chronic Hepatitis B

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02532413
• Other study ID #: 81461130019C5
• Status: Recruiting
• Phase: Phase 4
• First received: July 24, 2015
• Last updated: August 22, 2015
• Start date: July 2015
• Est. completion date: August 2017

Study information

• Verified date: August 2015
• Source: Wuhan Union Hospital, China
• Contact: Xin Zheng, M.D.
• Phone: (00)-86-02785726732
• Email: zheng2015uh[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate antiviral efficacy of the combination treatment with Poly IC and Entecavir and compare with the efficacy of Entecavir mono-therapy for chronic hepatitis B.

Description:

In this study, the patients with chronic HBV infection will be divided into two groups: HBeAg (+) and HBeAg (-) group. Each group will be divided into two subgroups, which are treated with combination treatment of Entecavir and Poly IC and Entecavir monotherapy respectively. All the patients will be followed up for one year. From this study, the investigators want to study if Poly IC can enhance antiviral efficacy of Entecavir for chronic hepatitis B.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: August 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• HBsAg positive for more than 6 months.

• Having been treated wit Entecavir and the level of HBV DNA is under 1000 copies/ml.

• ALT =10×ULN, TB <2ULN .

Exclusion Criteria:

• Previous antiviral treatment for HBV.

• Co infection of HIV, HCV, HEV, HAV, or HAV.

• Evidence of hepatic carcinoma.

• Evidence of autoimmune disease.

• Evidence of thyroid disease.

• History of mental sickness.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Poly IC
Poly IC can induce innate immune responses.It may enhance the antiviral efficacy of Entecavir.
• Entecavir
Entecavir can inhibit the replication of HBV.

Locations

Country	Name	City	State
China	Department of Infectious Disease of Wu Han Union Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with HBsAg serological response	The proportion of patients who achieve HBsAg serological response as assessed by the rate of HBsAg seroconversion.	at week 48 of treatment	No
Secondary	Changes in serum HBV DNA levels	Changes in serum HBV DNA levels during 48 weeks of treatment	at week 4,12,24,36,48,72,96 of treatment	No
Secondary	Biochemical Response (the serum levels of ALT and AST) Biochemical Response	Biochemical response as assessed by the serum levels of ALT, AST, TB, etc.	at week 1,2,4,8,12,16,20,24,36,48,72,96 of treatment	No
Secondary	Proportion of patients with HBeAg serological response	The proportion of patients who achieve HBeAg serological response as assessed by the rate of HBeAg loss or HBeAg seroconversion.	at week 48 of treatment	No