Optimal Treatment for Poor Efficacy of Entecavir in Chronic Hepatitis B Patients

Not Applicable

• Conditions: Chronic Hepatitis b; Efficacy, Self
• Interventions: Drug: Interferon Alfa 2a

• Registration Number: NCT03733652
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary

There are chronic hepatitis B patients with poor antiviral efficacy of entecavir in clinical practice. Tenofovir or interferon alfa is the optimal choice right now. The aim of this study is to investigate the therapeutic effect of using tenofovir of interferon alfa in these patients.

Detailed Description

There are chronic hepatitis B patients with poor antiviral efficacy of entecavir in clinical practice. Poor efficacy is defined as hepatitis b virus DNA is still positive and decreases \> 2 lg from baseline. Sequential therapy by using tenofovir or interferon alfa is the optimal choice right now. 100 patients with poor antiviral efficacy of entecavir will be recruited in this study. They are randomly divided into tenofovir group or interferon alfa group. The aim of this study is to investigate the therapeutic effect of using tenofovir of interferon alfa in these patients.

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2018-11-06
• Study First Posted: 2018-11-07
• Study Start: 2018-11-15
• Last Update Submitted: 2018-11-20
• Last Update Posted: 2018-11-23
• Primary Completion: 2021-09-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Hepatitis b virus DNA or HBsAg positive for over half a year;
2. Age from 18 to 65;
3. With poor efficacy of entecavir: Hepatitis b virus DNA is still positive at 24 weeks, and decrease > 2 lg from baseline .
4. Not be treated with interferon alfa ever before.

Exclusion Criteria

1. Other active liver diseases;
2. Cirrhosis, hepatocellular carcinoma or other malignancy;
3. Pregnancy or lactation;
4. Human immunodeficiency virus infection or congenital immune deficiency diseases;
5. Severe diabetes, autoimmune diseases;
6. Other important organ dysfunctions;
7. Patients can not follow-up.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interferon alfa	Interferon Alfa 2a	Patents are treated with interferon alfa 2a 180μg hypodermic injection once per week for 48 weeks. Then, interferon alfa 2a will be stopped if there is HBsAg clearance. Else, oral tenofovir 300mg once per day will be used if HBsAg is positive.

Primary Outcome Measures

Name	Time	Method
HBsAg decrease after 48 weeks treatment	48 weeks	The patients recruited will be treated with tenofovir or interferon alfa. After 48 weeks treatment, level of HBsAg will be tested again. The investigators want to know the rate of patients with HBsAg level that decreases more than 2 lg from baseline.

Secondary Outcome Measures

Name	Time	Method
HBsAg clearance after 48 weeks treatment	48 weeks	The patients recruited would be treated with tenofovir or interferon alfa. After 48 weeks treatment, level of HBsAg will be tested again. The investigators want to know the rate of patients with HBsAg clearance which is lower than 0.05 IU/ml.
Undetectable hepatitis b virus DNA after 48 weeks treatment	48 weeks	The patients recruited would be treated with tenofovir or interferon alfa. After 48 weeks treatment, level of hepatitis b virus DNA will be tested again. The investigators want to know the rate of patients with undetectable hepatitis b virus DNA which is lower than 20 IU/ml.

Trial Locations

Locations (1)

Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China