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Three Types of Nucleotide/Nucleoside Analogues Therapy in Patients With Hepatitis b Virus Related Compensated Cirrhosis

Primary Purpose

Hepatitis B, Compensated Cirrhosis

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, compensated cirrhosis, nucleoside, nucleotide

Eligibility Criteria

18 Years - 65 Years (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 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.

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

Incidence of decompensated cirrhosis
Incidence of decompensated cirrhosis is evaluated in the follow-up

Secondary Outcome Measures

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.
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.
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.
Serum calcium
Hypocalcemia would be evaluated after treatment
Serum phosphorus
Hypophosphatemia would be evaluated after treatment
Blood urea nitrogen
Blood urea nitrogen would be tested after treatment
Serum creatinine
Serum creatinine would be tested after treatment
Estimated glomerular filtration rate
Estimated glomerular filtration rate would be evaluated after treatment

Full Information

First Posted
December 9, 2019
Last Updated
December 10, 2019
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04196998
Brief Title
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

2. Study Status

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Compensated Cirrhosis
Keywords
hepatitis b virus, compensated cirrhosis, nucleoside, nucleotide

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
Incidence of decompensated cirrhosis
Description
Incidence of decompensated cirrhosis is evaluated in the follow-up
Time Frame
144 week
Secondary Outcome Measure Information:
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
Title
Ratio of patients with hepatitis b virus e antigen seroconversion after treatment
Description
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.
Time Frame
4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Title
Ratio of patients with undetectable hepatitis b virus surface antigen after treatment
Description
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.
Time Frame
4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Title
Serum calcium
Description
Hypocalcemia would be evaluated after treatment
Time Frame
4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Title
Serum phosphorus
Description
Hypophosphatemia would be evaluated after treatment
Time Frame
4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Title
Blood urea nitrogen
Description
Blood urea nitrogen would be tested after treatment
Time Frame
4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Title
Serum creatinine
Description
Serum creatinine would be tested after treatment
Time Frame
4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Title
Estimated glomerular filtration rate
Description
Estimated glomerular filtration rate would be evaluated 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
18 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 65 years old; Hepatitis b virus DNA positive; Cirrhosis or portal hypertension is found through ultrasonography, computed tomography or magnetic resonance imaging; Do not receive nucleotide/nucleoside analogues treatment in the past half year. Exclusion Criteria: Complications of decompensated cirrhosis: ascites, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome, etc; 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 Therapy in Patients With Hepatitis b Virus Related Compensated Cirrhosis

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