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

Not Applicable

• Conditions: Hepatitis B; Compensated Cirrhosis
• Interventions: Drug: Entecavir; Drug: Tenofovir Disoproxil Fumarate; Drug: Tenofovir alafenamide

• Registration Number: NCT04196998
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-10
• Last Update Submitted: 2019-12-10
• Study First Posted: 2019-12-12
• Last Update Posted: 2019-12-12
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ETV group	Entecavir	50 patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day from baseline to life-long.
TDF group	Tenofovir Disoproxil Fumarate	50 patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to life-long.
TAF group	Tenofovir alafenamide	50 patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day from baseline to life-long.

Primary Outcome Measures

Name	Time	Method
Incidence of decompensated cirrhosis	144 week	Incidence of decompensated cirrhosis is evaluated in the follow-up

Secondary Outcome Measures

Name	Time	Method
Ratio of patients with undetectable hepatitis b virus DNA after treatment	4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week	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.
Ratio of patients with hepatitis b virus e antigen seroconversion after treatment	4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week	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.
Blood urea nitrogen	4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week	Blood urea nitrogen would be tested after treatment
Ratio of patients with undetectable hepatitis b virus surface antigen after treatment	4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week	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.
Serum calcium	4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week	Hypocalcemia would be evaluated after treatment
Serum phosphorus	4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week	Hypophosphatemia would be evaluated after treatment
Serum creatinine	4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week	Serum creatinine would be tested after treatment
Estimated glomerular filtration rate	4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week	Estimated glomerular filtration rate would be evaluated after treatment

Trial Locations

Locations (1)

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