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Trial record 115 of 518 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Beijing Ditan Hospital
Sponsor:
Information provided by (Responsible Party):
Yao Xie, Beijing Ditan Hospital
ClinicalTrials.gov Identifier:
NCT02412592
First received: April 6, 2015
Last updated: August 17, 2016
Last verified: August 2016
  Purpose
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
Chronic Hepatitis B

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Beijing Ditan Hospital:

Primary Outcome Measures:
  • sustained viral response [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]
    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:
  • HBV DNA reaction [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]
    HBV DNA reaction was defined as HBV DNA load reverse back to detectable during observation period.

  • clinical relapse [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]
    clinical relapse is defined as virla relapse with abnormal ALT during observation period


Estimated Enrollment: 260
Study Start Date: January 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Yao Xie, liver diseases center, Beijing Ditan Hospital
ClinicalTrials.gov Identifier: NCT02412592     History of Changes
Other Study ID Numbers: DTXY009 
Study First Received: April 6, 2015
Last Updated: August 17, 2016
Health Authority: China: Beijing Municipal Science and Technology Commission

Keywords provided by 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

ClinicalTrials.gov processed this record on September 30, 2016