Three Types of Nucleotide/Nucleoside Analogues Therapy in Patients With Hepatitis b Virus Related Compensated Cirrhosis

Hepatitis B Clinical Trial

Official title:

Study on Therapeutic Effects and Safety of Three Types of Nucleotide/Nucleoside Analogues in Patients With Hepatitis b Virus Related Compensated Cirrhosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04196998
• Other study ID #: XWX2
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 2023

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 hepatitis b virus related compensated cirrhosis.

Description:

Hepatitis b virus infection 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 hepatitis b virus related compensated cirrhosis. This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of hepatitis b virus related compensated cirrhosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2023
• Est. primary completion date: December 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. Hepatitis b virus DNA positive;

4. Cirrhosis or portal hypertension is found through ultrasonography, computed tomography or magnetic resonance imaging;

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

Exclusion Criteria:

1. Complications of decompensated cirrhosis: ascites, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome, etc;

2. Other active liver diseases;

3. Hepatocellular carcinoma or other malignancy;

4. Pregnancy or lactation;

5. Human immunodeficiency virus infection or congenital immune deficiency diseases;

6. Severe diabetes, autoimmune diseases;

7. Other important organ dysfunctions;

8. Using glucocorticoid;

9. Patients can not follow-up;

10. Investigator considering inappropriate.

Related Conditions & MeSH terms

• Compensated Cirrhosis
• Fibrosis
• Hepatitis
• Hepatitis A
• Hepatitis B
• Liver Cirrhosis

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	Incidence of decompensated cirrhosis	Incidence of decompensated cirrhosis is evaluated in the follow-up	144 week
Secondary	Ratio of patients with undetectable hepatitis b virus DNA after treatment	Hepatitis b virus DNA would be tested to know the ratio of patients with undetectable hepatitis b virus DNA at 7 time points after treatment.	4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Secondary	Ratio of patients with hepatitis b virus e antigen seroconversion after treatment	Hepatitis b virus e antigen and e antibody would be tested to know the ratio of patients with hepatitis b virus e antigen seroconversion at 7 time points after treatment.	4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Secondary	Ratio of patients with undetectable hepatitis b virus surface antigen after treatment	Hepatitis b virus surface antigen would be tested to know the ratio of patients with undetectable hepatitis b virus surface antigen at 7 time points after treatment.	4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Secondary	Serum calcium	Hypocalcemia would be evaluated after treatment	4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Secondary	Serum phosphorus	Hypophosphatemia would be evaluated after treatment	4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Secondary	Blood urea nitrogen	Blood urea nitrogen would be tested after treatment	4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Secondary	Serum creatinine	Serum creatinine would be tested after treatment	4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Secondary	Estimated glomerular filtration rate	Estimated glomerular filtration rate would be evaluated after treatment	4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week