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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04195074
Other study ID # PL8
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date December 31, 2024

Study information

Verified date December 2019
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

This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of chronic hepatitis b


Description:

Chronic hepatitis b (CHB) remains a serious public health problem in China. Nucleotide/nucleoside analogues are used for anti-virus treatment in these patients. Entecavir, Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide are first line drug in China. But there still lacks of data of Tenofovir Alafenamide in treatment of CHB. This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of CHB.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

1. Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year;

2. Age from 18 to 65 years old;

3. HBeAg-positive: HBV DNA=20000IU/ml,HBeAg-negative: HBV DNA=2000IU/ml;

4. ALT=2×ULN;

5. Do not receive nucleotide/nucleoside analogues treatment in the past half year.

Exclusion Criteria:

1. Other active liver diseases;

2. 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. Using glucocorticoid;

8. Patients can not follow-up;

9. Investigator considering inappropriate.

Study Design


Intervention

Drug:
Entecavir
Patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day.
Tenofovir Disoproxil Fumarate
Patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day.
Tenofovir Alafenamide
Patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day.

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 Rate of renal function decline Renal function indicators mainly include blood urea nitrogen, serum creatine and estimated glomerular filtration rate, and the rate of renal function decline would be evaluated. 144 week
Primary Rate of hypercalcemia The serum calcium would be detected to know the ratio of patients with hypercalcemia. 144 week
Secondary hepatitis b virus(HBV) DNA undetectable rate Hepatitis b virus DNA would not be detected if it below the upper limit of test value. 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Secondary hepatitis b e antigen loss rate Hepatitis b e antigen would be tested to know the ratio of patients with negative hepatitis B e antigen. 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Secondary hepatitis b s antigen loss rate Hepatitis b s antigen become negative and quantitative analysis below the upper limit of test value. 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Secondary hepatitis b e antigen seroconversion rate hepatitis b e antibody would be tested to know the ratio of patients with positive hepatitis B e antibody 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
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