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Trial record 77 of 1136 for:    IFNA2 AND Antiviral Agents

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

Tracking Information
First Submitted Date  ICMJE November 13, 2016
First Posted Date  ICMJE November 25, 2016
Last Update Posted Date November 25, 2016
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2016)
good virologic response [ Time Frame: 24th week ]
level of HBsAg is less than or equal to 1500 IU/ml
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2016)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peginterferon Alfa-2b Treatment in HBeAg(+) Chronic Hepatitis b Patients Based on Interferon Gene Mutation and Receptor Detection
Official Title  ICMJE 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
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.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis b
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Entecavir or Tenofovir
    • 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.
    Intervention: Drug: Peginterferon Alfa-2B
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 23, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02973646
Other Study ID Numbers  ICMJE PL2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University
Study Sponsor  ICMJE Third Affiliated Hospital, Sun Yat-Sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Liang Peng, Doctor Third Affiliated Hospital, Sun Yat-Sen University
PRS Account Third Affiliated Hospital, Sun Yat-Sen University
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP