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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

Tracking Information
First Submitted Date  ICMJE November 6, 2018
First Posted Date  ICMJE November 7, 2018
Last Update Posted Date November 22, 2018
Estimated Study Start Date  ICMJE November 15, 2018
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 6, 2018)
ratio of patients with HBsAg decrease [ Time Frame: 48 weeks ]
ratio of patients with decreasing level of HBsAg > 2 lg from baseline
Change History Complete list of historical versions of study NCT03733652 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2018)
  • HBsAg clearance [ Time Frame: 48 weeks ]
    HBsAg < 0.05 IU/ml
  • undetectable hepatitis b virus DNA [ Time Frame: 48 weeks ]
    hepatitis b virus DNA can not be detected
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimal Treatment for Poor Efficacy of Entecavir in Chronic Hepatitis B Patients
Official Title  ICMJE Study on the Optimal Treatment for Poor Efficacy of Entecavir in Chronic Hepatitis B Patients
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Hepatitis b
  • Efficacy, Self
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Interferon Alfa 2a
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 6, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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: Wenxiong Xu, Doctor +8613760783281 xwx1983@163.com
Contact: Liang Peng, Doctor +8613533978874 pzp33@hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03733652
Other Study ID Numbers  ICMJE PL3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
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 of Sun Yat-sen University
PRS Account Third Affiliated Hospital, Sun Yat-Sen University
Verification Date November 2018

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