- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02532413
Antiviral Efficacy of the Combination Treatment With Poly IC and Entecavir for Chronic Hepatitis B
Comparison of Antiviral Efficacy of Entecavir Monotherapy and Combination Treatment With Poly IC for Chronic Hepatitis B
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Xin Zheng, M.D.
- Phone Number: (00)-86-02785726732
- Email: zheng2015uh@163.com
Study Contact Backup
- Name: Jin Tian, M.S.
- Phone Number: (00)-86-02785726132
- Email: tjxhtj@126.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430022
- Recruiting
- Department of Infectious Disease of Wu Han Union Hospital
-
Contact:
- Xin Zheng, M.D.
- Phone Number: (00)-86-02785726732
- Email: zheng2015uh@163.com
-
Contact:
- Jin Tian, M.S.
- Phone Number: (00)-86-02785726132
- Email: tjxhtj@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HBeAg(+):Poly IC+Entecavir
45 subjects(HBeAg-positive chronic hepatitis B). Combination therapy will last 24 weeks from 0 week. Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks. Drug: PolyIC 2mg,im,qod,duration:from 0 week to 24th week |
Poly IC can induce innate immune responses.It may enhance the antiviral efficacy of Entecavir.
Other Names:
Entecavir can inhibit the replication of HBV.
Other Names:
|
Active Comparator: HBeAg(+):Entecavir
45 subjects(HBeAg-positive chronic hepatitis B).
Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks.
|
Entecavir can inhibit the replication of HBV.
Other Names:
|
Experimental: HBeAg(-):Poly IC+Entecavir
45 subjects(HBeAg-negative chronic hepatitis B). Combination treatment will last 24 weeks from 0 week. Drug: Enticavir 0.5mg, P.O.,qd, duration:48 weeks. Drug: PolyIC 2mg,im,qod,duration:from 0 week to 24th week |
Poly IC can induce innate immune responses.It may enhance the antiviral efficacy of Entecavir.
Other Names:
Entecavir can inhibit the replication of HBV.
Other Names:
|
Active Comparator: HBeAg(-):Entecavir
45 subjects(HBeAg-negative chronic hepatitis B).
Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks.
|
Entecavir can inhibit the replication of HBV.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients with HBsAg serological response
Time Frame: at week 48 of treatment
|
The proportion of patients who achieve HBsAg serological response as assessed by the rate of HBsAg seroconversion.
|
at week 48 of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in serum HBV DNA levels
Time Frame: at week 4,12,24,36,48,72,96 of treatment
|
Changes in serum HBV DNA levels during 48 weeks of treatment
|
at week 4,12,24,36,48,72,96 of treatment
|
Biochemical Response (the serum levels of ALT and AST) Biochemical Response
Time Frame: at week 1,2,4,8,12,16,20,24,36,48,72,96 of treatment
|
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
|
Proportion of patients with HBeAg serological response
Time Frame: at week 48 of treatment
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Liang D Yang, M.D., Huanzhong University of Science and Technology
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Hepatitis, Chronic
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Immunologic Factors
- Interferon Inducers
- Entecavir
- Poly I-C
Other Study ID Numbers
- 81461130019C5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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