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Three Types of Nucleotide/Nucleoside Analogues Treatment in HBV Related ACLF (HBV)

Primary Purpose

Hepatitis B, Acute-On-Chronic Liver Failure

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Entecavir
Tenofovir Disoproxil Fumarate
Tenofovir Alafenamide
Sponsored by
Third Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B focused on measuring hepatitis b virus, acute-on-chronic liver failure, nucleotide, nucleoside

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Third Affiliated Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

ETV group

TDF group

TAF group

Arm Description

50 patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day from baseline to life-long.

50 patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to life-long.

50 patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day from baseline to life-long.

Outcomes

Primary Outcome Measures

Survival rate in the follow-up
Whether patients will survive after treatment is observed in the follow-up.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 16, 2019
Last Updated
April 17, 2019
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03920618
Brief Title
Three Types of Nucleotide/Nucleoside Analogues Treatment in HBV Related ACLF
Acronym
HBV
Official Title
Study on Three Types of Nucleotide/Nucleoside Analogues Treatment in Patients With Hepatitis b Virus Related Acute-on-chronic Liver Failure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Acute-On-Chronic Liver Failure
Keywords
hepatitis b virus, acute-on-chronic liver failure, nucleotide, nucleoside

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ETV group
Arm Type
Active Comparator
Arm Description
50 patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day from baseline to life-long.
Arm Title
TDF group
Arm Type
Active Comparator
Arm Description
50 patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to life-long.
Arm Title
TAF group
Arm Type
Experimental
Arm Description
50 patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day from baseline to life-long.
Intervention Type
Drug
Intervention Name(s)
Entecavir
Other Intervention Name(s)
Baraclude
Intervention Description
Patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day.
Intervention Type
Drug
Intervention Name(s)
Tenofovir Disoproxil Fumarate
Other Intervention Name(s)
Viread
Intervention Description
Patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day.
Intervention Type
Drug
Intervention Name(s)
Tenofovir Alafenamide
Other Intervention Name(s)
Vemlidy
Intervention Description
Patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day.
Primary Outcome Measure Information:
Title
Survival rate in the follow-up
Description
Whether patients will survive after treatment is observed in the follow-up.
Time Frame
144 week
Secondary Outcome Measure Information:
Title
Model for end-stage liver disease (MELD) score is recorded after treatment
Description
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.
Time Frame
0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Title
Ratio of patients with undetectable hepatitis b virus DNA after treatment
Description
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.
Time Frame
4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year; Age from 18 to 55 years old; Serum total bilirubin level > 10 times upper limit of normal; Prothrombin time activity < 40% or prothrombin time international ratio > 1.5； Do not receive nucleotide/nucleoside analogues treatment in the past half year. Exclusion Criteria: Other active liver diseases; Hepatocellular carcinoma or other malignancy; Pregnancy or lactation; Human immunodeficiency virus infection or congenital immune deficiency diseases; Severe diabetes, autoimmune diseases; Other important organ dysfunctions; Using glucocorticoid; Patients can not follow-up; Investigator considering inappropriate.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenxiong Xu, Doctor
Phone
+8613760783281
Email
xwx1983@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liang Peng, Doctor
Phone
+8613533978874
Email
pzp33@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang Peng, Doctor
Organizational Affiliation
Third Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Peng, Doctor
Phone
+8613533978874
Email
pzp33@hotmail.com

12. IPD Sharing Statement

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Three Types of Nucleotide/Nucleoside Analogues Treatment in HBV Related ACLF

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