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

December 10, 2019 updated by: Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University

Study on Therapeutic Effects and Safety of Three Types of Nucleotide/Nucleoside Analogues in Patients With 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • Third Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.
Other Names:
  • Baraclude
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.
Other Names:
  • Viread
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.
Other Names:
  • Vemlidy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of decompensated cirrhosis
Time Frame: 144 week
Incidence of decompensated cirrhosis is evaluated in the follow-up
144 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Ratio of patients with hepatitis b virus e antigen seroconversion after treatment
Time Frame: 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
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.
4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Ratio of patients with undetectable hepatitis b virus surface antigen after treatment
Time Frame: 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
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.
4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Serum calcium
Time Frame: 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Hypocalcemia would be evaluated after treatment
4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Serum phosphorus
Time Frame: 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Hypophosphatemia would be evaluated after treatment
4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Blood urea nitrogen
Time Frame: 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Blood urea nitrogen would be tested after treatment
4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Serum creatinine
Time Frame: 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Serum creatinine would be tested after treatment
4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Estimated glomerular filtration rate
Time Frame: 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Estimated glomerular filtration rate would be evaluated after treatment
4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

December 10, 2019

First Posted (ACTUAL)

December 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 12, 2019

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XWX2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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