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Optimal Treatment for Poor Efficacy of Entecavir in Chronic Hepatitis B Patients

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ClinicalTrials.gov Identifier: NCT03733652
Recruitment Status : Not yet recruiting
First Posted : November 7, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary:
There are chronic hepatitis B patients with poor antiviral efficacy of entecavir in clinical practice. Tenofovir or interferon alfa is the optimal choice right now. The aim of this study is to investigate the therapeutic effect of using tenofovir of interferon alfa in these patients.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis b Efficacy, Self Drug: Interferon Alfa 2a Not Applicable

Detailed Description:
There are chronic hepatitis B patients with poor antiviral efficacy of entecavir in clinical practice. Poor efficacy is defined as hepatitis b virus DNA is still positive and decreases > 2 lg from baseline. Sequential therapy by using tenofovir or interferon alfa is the optimal choice right now. 100 patients with poor antiviral efficacy of entecavir will be recruited in this study. They are randomly divided into tenofovir group or interferon alfa group. The aim of this study is to investigate the therapeutic effect of using tenofovir of interferon alfa in these patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study on the Optimal Treatment for Poor Efficacy of Entecavir in Chronic Hepatitis B Patients
Estimated Study Start Date : November 15, 2018
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Tenofovir
Patents are treated with oral tenofovir 300mg once per day for 48 weeks. Then, tenofovir will be stopped if there is HBsAg clearance. Else, oral tenofovir 300mg once per day will be continued if HBsAg is positive.
Active Comparator: Interferon alfa
Patents are treated with interferon alfa 2a 180μg hypodermic injection once per week for 48 weeks. Then, interferon alfa 2a will be stopped if there is HBsAg clearance. Else, oral tenofovir 300mg once per day will be used if HBsAg is positive.
Drug: Interferon Alfa 2a
Patents are treated with interferon alfa 2a 180μg hypodermic injection once per week for 48 weeks. Then, interferon alfa 2a will be stopped if there is HBsAg clearance. Else, oral tenofovir 300mg once per day will be used if HBsAg is positive.
Other Name: Pegasys




Primary Outcome Measures :
  1. HBsAg decrease after 48 weeks treatment [ Time Frame: 48 weeks ]
    The patients recruited will be treated with tenofovir or interferon alfa. After 48 weeks treatment, level of HBsAg will be tested again. The investigators want to know the rate of patients with HBsAg level that decreases more than 2 lg from baseline.


Secondary Outcome Measures :
  1. HBsAg clearance after 48 weeks treatment [ Time Frame: 48 weeks ]
    The patients recruited would be treated with tenofovir or interferon alfa. After 48 weeks treatment, level of HBsAg will be tested again. The investigators want to know the rate of patients with HBsAg clearance which is lower than 0.05 IU/ml.

  2. Undetectable hepatitis b virus DNA after 48 weeks treatment [ Time Frame: 48 weeks ]
    The patients recruited would be treated with tenofovir or interferon alfa. After 48 weeks treatment, level of hepatitis b virus DNA will be tested again. The investigators want to know the rate of patients with undetectable hepatitis b virus DNA which is lower than 20 IU/ml.



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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. Hepatitis b virus DNA or HBsAg positive for over half a year;
  2. Age from 18 to 65;
  3. With poor efficacy of entecavir: Hepatitis b virus DNA is still positive at 24 weeks, and decrease > 2 lg from baseline .
  4. Not be treated with interferon alfa ever before.

Exclusion Criteria:

  1. Other active liver diseases;
  2. Cirrhosis, 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. Patients can not follow-up.

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): NCT03733652


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
Guangzhou, Guangdong, China, 510630
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, Professor, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03733652     History of Changes
Other Study ID Numbers: PL3
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
entecavir

Additional relevant MeSH terms:
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Interferon alpha-2
Interferon-alpha
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Interferons
Tenofovir
Entecavir
Antineoplastic Agents
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
Immunologic Factors
Physiological Effects of Drugs