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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04196998
Other study ID # XWX2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
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 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.

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 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
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