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

  • Clinicaltrials.gov identifier

    NCT03920618

  • Recruitment Status

    Recruiting

  • First Posted

    April 19, 2019

  • Last update posted

    April 19, 2019

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.

  • Condition or Disease:Hepatitis B
    Acute-On-Chronic Liver Failure
  • Intervention/Treatment: Drug: Entecavir
    Drug: Tenofovir Disoproxil Fumarate
    Drug: Tenofovir Alafenamide
  • Phase: N/A

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.

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 150 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Study on Three Types of Nucleotide/Nucleoside Analogues Treatment in Patients With Hepatitis b Virus Related Acute-on-chronic Liver Failure
  • Actual Study Start Date: February 2019
  • Estimated Primary Completion Date: October 2023
  • Estimated Study Completion Date: December 2023

Arms and interventions

Arm Intervention/treatment
Active Comparator: ETV group
50 patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day from baseline to life-long.
Drug: Entecavir
Patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day.
Active Comparator: TDF group
50 patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to life-long.
Drug: Tenofovir Disoproxil Fumarate
Patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day.
Experimental: TAF group
50 patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day from baseline to life-long.
Drug: Tenofovir Alafenamide
Patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day.

Outcome Measures

  • Primary Outcome Measures: 1. Survival rate in the follow-up [ Time Frame: 144 week ]
    Whether patients will survive after treatment is observed in the follow-up.
  • Secondary Outcome Measures: 1. Model for end-stage liver disease (MELD) score is recorded after treatment [ Time Frame: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week ]
    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.
  • 2. Ratio of patients with undetectable hepatitis b virus DNA after treatment [ Time Frame: 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.

Eligibility Criteria

  • Ages Eligible for Study: 12 to 65 Years (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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 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.

Contacts and Locations

Contacts

Contact: Wenxiong Xu, Doctor +8613760783281 xwx1983@163.com

Contact: Liang Peng, Doctor +8613533978874 pzp33@hotmail.com

Locations

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

Sponsors and Collaborators

Third Affiliated Hospital, Sun Yat-Sen University

Investigators

Principal Investigator: Liang Peng, Doctor Third Affiliated Hospital of Sun Yat-sen University

More Information

  • Responsible Party: Third Affiliated Hospital, Sun Yat-Sen University
  • ClinicalTrials.gov Identifier: NCT03920618 History of Changes
  • Other Study ID Numbers: PL6
  • First Posted: April 19, 2019 Key Record Dates
  • Last Update Posted: April 19, 2019
  • Last Verified: April 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Third Affiliated Hospital, Sun Yat-Sen University: nucleoside
    hepatitis b virus
    acute-on-chronic liver failure
    nucleotide
  • Additional relevant MeSH terms: Hepatic Insufficiency
    End Stage Liver Disease
    Acute-On-Chronic Liver Failure
    Hepatitis A
    Hepatitis B
    Hepatitis
    Liver Failure