Back to resultsThree Types of Nucleotide/Nucleoside Analogues Therapy in Patients With Chronic Hepatitis b
Primary Purpose
Chronic Hepatitis b
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Entecavir
Tenofovir Disoproxil Fumarate
Tenofovir Alafenamide
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis b focused on measuring chronic hepatitis b, nucleoside, nucleotide
Eligibility Criteria
Inclusion Criteria:
- Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year;
- Age from 18 to 65 years old;
- HBeAg-positive: HBV DNA≥20000IU/ml，HBeAg-negative: HBV DNA≥2000IU/ml；
- ALT≥2×ULN；
- 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.
Sites / Locations
- Third Affiliated Hospital of Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
ETV group
TDF group
TAF group
Arm Description
100 patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day from baseline to life-long.
100 patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to life-long.
100 patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day from baseline to life-long.
Outcomes
Primary Outcome Measures
Rate of renal function decline
Renal function indicators mainly include blood urea nitrogen, serum creatine and estimated glomerular filtration rate, and the rate of renal function decline would be evaluated.
Rate of hypercalcemia
The serum calcium would be detected to know the ratio of patients with hypercalcemia.
Secondary Outcome Measures
hepatitis b virus(HBV) DNA undetectable rate
Hepatitis b virus DNA would not be detected if it below the upper limit of test value.
hepatitis b e antigen loss rate
Hepatitis b e antigen would be tested to know the ratio of patients with negative hepatitis B e antigen.
hepatitis b s antigen loss rate
Hepatitis b s antigen become negative and quantitative analysis below the upper limit of test value.
hepatitis b e antigen seroconversion rate
hepatitis b e antibody would be tested to know the ratio of patients with positive hepatitis B e antibody
Full Information
NCT ID
NCT04195074
First Posted
December 5, 2019
Last Updated
December 15, 2019
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT04195074
Brief Title
Three Types of Nucleotide/Nucleoside Analogues Therapy in Patients With Chronic Hepatitis b
Official Title
Study on Therapeutic Effects and Safety of Three Types of Nucleotide/Nucleoside Analogues in Patients With Chronic Hepatitis b
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 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (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
Product Manufactured in and Exported from the U.S.
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 chronic hepatitis b
Detailed Description
Chronic hepatitis b (CHB) 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 CHB. This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of CHB.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis b
Keywords
chronic hepatitis b, 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
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ETV group
Arm Type
Experimental
Arm Description
100 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
Experimental
Arm Description
100 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
100 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
Rate of renal function decline
Description
Renal function indicators mainly include blood urea nitrogen, serum creatine and estimated glomerular filtration rate, and the rate of renal function decline would be evaluated.
Time Frame
144 week
Title
Rate of hypercalcemia
Description
The serum calcium would be detected to know the ratio of patients with hypercalcemia.
Time Frame
144 week
Secondary Outcome Measure Information:
Title
hepatitis b virus(HBV) DNA undetectable rate
Description
Hepatitis b virus DNA would not be detected if it below the upper limit of test value.
Time Frame
0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Title
hepatitis b e antigen loss rate
Description
Hepatitis b e antigen would be tested to know the ratio of patients with negative hepatitis B e antigen.
Time Frame
0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Title
hepatitis b s antigen loss rate
Description
Hepatitis b s antigen become negative and quantitative analysis below the upper limit of test value.
Time Frame
0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Title
hepatitis b e antigen seroconversion rate
Description
hepatitis b e antibody would be tested to know the ratio of patients with positive hepatitis B e antibody
Time Frame
0 week, 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;
HBeAg-positive: HBV DNA≥20000IU/ml，HBeAg-negative: HBV DNA≥2000IU/ml；
ALT≥2×ULN；
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 Therapy in Patients With Chronic Hepatitis b
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