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Trial record 77 of 324 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Sustained Viral Response in Chronic Hepatitis B Patients Who Achieved HBeAg Seroncongversion After Interferon Therapy

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ClinicalTrials.gov Identifier: NCT02412592
Recruitment Status : Recruiting
First Posted : April 9, 2015
Last Update Posted : August 18, 2016
Sponsor:
Information provided by (Responsible Party):
Yao Xie, Beijing Ditan Hospital

Brief Summary:
Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of cirrhosis and hepatocellular carcinoma (HCC). HBeAg seroconversion is considered to be the satisfied endpoint of antiviral therapy in HBeAg-positive chronic hepatitis B patients. However, HBV reaction, even reverse back to HBeAg positive and clinical relapse could occur in some patients who achieved HBeAg seronconversion by interferon treatment. In this study, the long-term efficacy of interferon therapy in HBeAg positive patients achieved HBeAg seronconversion after interferon treatment and the factors associated with viral and clinical relapse will be observed.

Condition or disease
Chronic Hepatitis B

Detailed Description:
HBeAg positive chronic hepatitis B patients achieved HBeAg seronconversion by interferon treatment will be enrolled and observed for 156 weeks. Serum HBV DNA, HBsAg, anti-HBs, HBeAg, and anti-HBe will be measured every 3 months during the observation period, liver function tests were performed every 3 months also. The liver ultrasonic examination would be taken every 3-6 months. The primary endpoint is sustained viral response, and secondary endpoints is HBV DNA reaction and clinical relapse defined as virla relapse with abnormal ALT during observation period.

Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sustained Viral Response and Clincal Relapse in Chronic Hepatitis B Patients Who Achieved HBeAg Seroncongversion by Interferon Therapy
Study Start Date : January 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon
U.S. FDA Resources




Primary Outcome Measures :
  1. sustained viral response [ Time Frame: 156 weeks ]
    The serum HBV DNA load and HBeAg level will be tested every 3 month for 156 weeks after completed treatment in patients who achieved HBeAg seroconversion by interferon treatment. The rate of sustained viral response defined HBV DNA maintaining undetectable during observation period will be evaluated.


Secondary Outcome Measures :
  1. HBV DNA reaction [ Time Frame: 156 weeks ]
    HBV DNA reaction was defined as HBV DNA load reverse back to detectable during observation period.

  2. clinical relapse [ Time Frame: 156 weeks ]
    clinical relapse is defined as virla relapse with abnormal ALT during observation period



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population in this study were composed of HBeAg positive chronic hepatitis B patients achieved HBeAg seroconversion by interferon treatment, and serum HBsAg, anti-HBs, HBeAg, anti-HBe, and HBV DNA would be tested every 3 months for 156 weeks after finished treatment. The sustained viral response defined HBV DNA mantaining undetectable would be evalued during the observation period.
Criteria

Inclusion Criteria:

  • patients who achieved HBeAg seroconversion by interferon treatment.

Exclusion Criteria:

  • 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

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): NCT02412592


Contacts
Contact: yao xie, MD 8610-84322210 ext 1489 xieyao00120184@sina.com

Locations
China, Beijing
Yao Xie Recruiting
Beijing, Beijing, China, 100015
Contact: Yao Xie, MD    8610-8432220 ext 2489    xieyao00120184@sina.com   
Sponsors and Collaborators
Beijing Ditan Hospital

Responsible Party: Yao Xie, liver diseases center, Beijing Ditan Hospital
ClinicalTrials.gov Identifier: NCT02412592     History of Changes
Other Study ID Numbers: DTXY009
First Posted: April 9, 2015    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: August 2016

Keywords provided by Yao Xie, Beijing Ditan Hospital:
HBeAg positive
interferon
peginterferon
HBeAg seroconversion
sustained viral response
relapse

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents