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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03733652
Other study ID # PL3
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 15, 2018
Est. completion date December 31, 2021

Study information

Verified date November 2018
Source Third Affiliated Hospital, Sun Yat-Sen University
Contact Wenxiong Xu, Doctor
Phone +8613760783281
Email xwx1983@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 31, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Intervention

Drug:
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.

Locations

Country Name City State
China Third Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary HBsAg decrease after 48 weeks treatment 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. 48 weeks
Secondary HBsAg clearance after 48 weeks treatment 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. 48 weeks
Secondary Undetectable hepatitis b virus DNA after 48 weeks treatment 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. 48 weeks
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