Three Types of Nucleotide/Nucleoside Analogues Therapy in Patients With Chronic Hepatitis b

Chronic Hepatitis b Clinical Trial

Official title:

Study on Therapeutic Effects and Safety of Three Types of Nucleotide/Nucleoside Analogues in Patients With Chronic Hepatitis b

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04195074
• Other study ID #: PL8
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

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

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