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Three Types of Nucleotide/Nucleoside Analogues Therapy in Patients With Chronic Hepatitis b

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04195074
Recruitment Status : Recruiting
First Posted : December 11, 2019
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University

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

Condition or disease Intervention/treatment Phase
Chronic Hepatitis b Drug: Entecavir Drug: Tenofovir Disoproxil Fumarate Drug: Tenofovir Alafenamide Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study on Therapeutic Effects and Safety of Three Types of Nucleotide/Nucleoside Analogues in Patients With Chronic Hepatitis b
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024


Arm Intervention/treatment
Experimental: ETV group
100 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 Name: Baraclude

Experimental: TDF group
100 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 Name: Viread

Experimental: TAF group
100 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 Name: Vemlidy




Primary Outcome Measures :
  1. Rate of renal function decline [ Time Frame: 144 week ]
    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.

  2. Rate of hypercalcemia [ Time Frame: 144 week ]
    The serum calcium would be detected to know the ratio of patients with hypercalcemia.


Secondary Outcome Measures :
  1. hepatitis b virus(HBV) DNA undetectable rate [ Time Frame: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week ]
    Hepatitis b virus DNA would not be detected if it below the upper limit of test value.

  2. hepatitis b e antigen loss rate [ Time Frame: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week ]
    Hepatitis b e antigen would be tested to know the ratio of patients with negative hepatitis B e antigen.

  3. hepatitis b s antigen loss rate [ Time Frame: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week ]
    Hepatitis b s antigen become negative and quantitative analysis below the upper limit of test value.

  4. hepatitis b e antigen seroconversion rate [ Time Frame: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week ]
    hepatitis b e antibody would be tested to know the ratio of patients with positive hepatitis B e antibody



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Ages Eligible for Study:   18 Years to 65 Years   (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 65 years old;
  3. HBeAg-positive: HBV DNA≥20000IU/ml,HBeAg-negative: HBV DNA≥2000IU/ml;
  4. ALT≥2×ULN;
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04195074


Contacts
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Contact: Wenxiong Xu, Doctor +8613760783281 xwx1983@163.com
Contact: Liang Peng, Doctor +8613533978874 pzp33@hotmail.com

Locations
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China, Guangdong
Third Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Liang Peng, Doctor    +8613533978874    pzp33@hotmail.com   
Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Investigators
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Principal Investigator: Liang Peng, Doctor Third Affiliated Hospital of Sun Yat-sen University
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Responsible Party: Liang Peng, Professer, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT04195074    
Other Study ID Numbers: PL8
First Posted: December 11, 2019    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019

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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
Keywords provided by Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University:
chronic hepatitis b
nucleoside
nucleotide
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Tenofovir
Entecavir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents