Clinical trial NCT04196998: Three Types of Nucleotide/Nucleoside Analogues Therapy in Patients With Hepatitis b Virus Related Compensated Cirrhosis
Official title: Study on Therapeutic Effects and Safety of Three Types of Nucleotide/Nucleoside Analogues in Patients With Hepatitis b Virus Related Compensated Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis B
Compensated Cirrhosis
Keywords: hepatitis b virus
compensated cirrhosis
nucleoside
nucleotide
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of decompensated cirrhosis
timeFrame: 144 week
Secondary outcomes:
measure: Ratio of patients with undetectable hepatitis b virus DNA after treatment
timeFrame: 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
measure: Ratio of patients with hepatitis b virus e antigen seroconversion after treatment
timeFrame: 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
measure: Ratio of patients with undetectable hepatitis b virus surface antigen after treatment
timeFrame: 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
measure: Serum calcium
timeFrame: 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
measure: Serum phosphorus
timeFrame: 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
measure: Blood urea nitrogen
timeFrame: 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
measure: Serum creatinine
timeFrame: 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
measure: Estimated glomerular filtration rate
timeFrame: 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Liang Peng, Doctor
role: PRINCIPAL_INVESTIGATOR
References: