Efficacy of Extended Peginterferon Alpha 2a Treatment in HBeAg Positive Chronic Hepatitis B Patients
1 other identifier
observational
160
1 country
1
Brief Summary
The most important method to slow down and stop the liver disease progression in patients with chronic hepatitis B is antiviral therapy, by which to achieve maintaining viral response during treatment or obtain sustained viral response after treatment. The aim of the therapy with interferon is make patients obtain immune control to HBV, in clinical practice, it was expressed as HBeAg seroconversion, HBsAg loss and sustained viral response in HBeAg positive patients. However, those targets can't be get in most patients by 48 weeks of interferon treatment, and some patients need extended treatment to enhance the rate of HBeAg seroconversion and HBsAg loss. In this cohort study, the efficacies of extended therapy of interferon in HBeAg positive chronic hepatitis B patients will be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 8, 2015
CompletedFirst Posted
Study publicly available on registry
March 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 21, 2017
CompletedJuly 6, 2017
July 1, 2017
5.2 years
March 8, 2015
July 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rate of HBeAg seroconversion (defined as HBeAg loss with anti-HBe positive after PEG-IFN a-2a treatment and follow up)
HBeAg seroconversion was defined as HBeAg loss with anti-HBe positive after PEG-IFN a-2a treatment and follow up.
120 weeks
Secondary Outcomes (2)
rate of HBsAg loss (defined as HBsAg level lower than 0.05 IU/ml)
96 weeks
rate of sustained viral response (defined as serum HBV DNA undetectable at the end of treatment and the end of follow up)
120 weeks
Eligibility Criteria
the population in this cohort study was composed of HBeAg positive chronic hepatitis B patients defined as HBsAg positive, HBeAg positive, and detectable HBV DNA load with ALT level ≥41 U/L for more than 6 months.
You may qualify if:
- HBeAg positive chronic hepatitis B patients
You may not qualify if:
- Active consumption of alcohol and/or drugs
- Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
- History of autoimmune hepatitis
- Psychiatric disease
- Evidence of neoplastic diseases of the liver
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Ditan hospital,Capital Medical University
Beijing, Beijing Municipality, 100015, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- liver diseases center
Study Record Dates
First Submitted
March 8, 2015
First Posted
March 13, 2015
Study Start
March 1, 2012
Primary Completion
May 21, 2017
Study Completion
May 21, 2017
Last Updated
July 6, 2017
Record last verified: 2017-07