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Peginterferon Alfa-2b Treatment in HBeAg(+) Chronic Hepatitis b Patients Based on Interferon Gene Mutation and Receptor Detection

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ClinicalTrials.gov Identifier: NCT02973646
Recruitment Status : Unknown
Verified November 2016 by Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Recruiting
First Posted : November 25, 2016
Last Update Posted : November 25, 2016
Sponsor:
Information provided by (Responsible Party):
Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary:
The study is to observe the anti-HBV therapeutic effects of peginterferon alfa-2b in chronic hepatitis b patients with e antigen positive based on the detection of interferon gene mutation (IFNA2 p.Ala120Thr) and interferon receptor (IFNAR2) detection.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis b Drug: Entecavir or Tenofovir Drug: Peginterferon Alfa-2B Phase 4

Detailed Description:
Patients with e antigen positive chronic hepatitis b were enrolled in the study. Age, sex, symptoms (e.g., fever, fatigue, poor appetite, jaundice) were recorded in the study. We also observed the laboratory test results including the levels of white blood cells (WBC), red blood cells (RBC), hemoglobin (HGB), platelet (PLT), alanine transaminase (ALT), aspartate transaminase (AST), hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis B e antibody (HBeAb), and hepatitis B virus (HBV) DNA; detection of gene mutation (IFNA2 p.Ala120Thr), levels of interferon receptor (IFNAR2).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation on Antiviral Therapy of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B Patients Based on Detection of Interferon Gene Mutation and Interferon Receptor
Study Start Date : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Nucleos(t)ide analogues treatment
Patients with interferon receptor level down-regulated at the 24th week. Patients of this group will receive peginterferon alfa-2b injection 80ug/d from baseline to 24th week, then nucleos(t)ide analogues (entecavir tablet 0.5mg/d or tenofovir tablet 300mg/d) from 25th to 36th week, then peginterferon alfa-2b injection 80ug/d again from 36th to 48th week.
Drug: Entecavir or Tenofovir
Patients in nucleos(t)ide analogues treatment for 12 weeks group will receive nucleos(t)ide analogs therapy (Entecavir tablet 0.5mg/d or Tenofovir tablet 300mg/d) from Week 25th to 36th.
Other Names:
  • Baraclude
  • Viread

Drug: Peginterferon Alfa-2B
Active Comparator: Peginterferon treatment
Patients with interferon receptor level not down-regulated at the 24th week. Patients of this group will receive peginterferon alfa-2b injection 80ug/d from baseline to 48th week.
Drug: Peginterferon Alfa-2B



Primary Outcome Measures :
  1. good virologic response [ Time Frame: 24th week ]
    level of HBsAg is less than or equal to 1500 IU/ml


Secondary Outcome Measures :
  1. common virologic response [ Time Frame: 24th week ]
    level of HBsAg is more than 1500 IU/ml, also less than or equal to 20000 IU/ml

  2. bad virologic response [ Time Frame: 24th week ]
    level of HBsAg is more than 20000 IU/ml, level of HBV DNA is equal to or more than 4.0 log10 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. Chronic hepatitis b Patients who should receive anti-HBV therapy according to guideline and are willing to receive interferon therapy;
  2. Hepatitis B e antigen positive.

Exclusion Criteria:

  1. Patients received anti-HBV therapy in the past 6 months;
  2. Patients with liver cirrhosis or hepatocellular carcinoma or other malignancies;
  3. Patients with other factors causing active liver diseases;
  4. Pregnancy or lactation women;
  5. Patients with HIV infection or congenital immune deficiency diseases;
  6. Patients with severe diabetes, autoimmune diseases, other important organ dysfunctions and other serious complications.
  7. Patients with other reasons not suitable to receive interferon therapy.

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): NCT02973646


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

Locations
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China, Guangdong
The 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, Sun Yat-Sen University

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Responsible Party: Liang Peng, Associated Professor, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02973646     History of Changes
Other Study ID Numbers: PL2
First Posted: November 25, 2016    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016
Keywords provided by Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University:
chronic hepatitis b
peginterferon alfa-2b
interferon gene mutation
interferon receptor
Additional relevant MeSH terms:
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Peginterferon alfa-2b
Interferon-alpha
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
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