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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03920618
Other study ID # PL6
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date December 31, 2023

Study information

Verified date April 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 of three types of nucleotide/nucleoside analogues in treatment of HBV-related acute-on-chronic liver failure.


Description:

Hepatitis b virus (HBV) related acute-on-chronic liver failure (ACLF) is a serious condition with high mortality rate 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 HBV related ACLF. This study is to investigate the clinical efficacy of three types of nucleotide/nucleoside analogues in treatment of HBV related ACLF.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender All
Age group 12 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 55 years old;

3. Serum total bilirubin level > 10 times upper limit of normal;

4. Prothrombin time activity < 40% or prothrombin time international ratio > 1.5;

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.

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 Survival rate in the follow-up Whether patients will survive after treatment is observed in the follow-up. 144 week
Secondary Model for end-stage liver disease (MELD) score is recorded after treatment The calculation of model for end-stage liver disease (MELD) score is: R=0.378ln[serum total bilirubin (mg/dl)]+1.12ln(prothrombin time international normalized ratio)+0.95ln[serum creatinin(mg/dl)]+0.64. The higher the MELD score, the higher the mortality rate. MELD score is recorded after treatment. 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,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
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