Trial record 57 of 351 for:    hepatitis b | Open Studies

Efficacy of Extended Peginterferon Alpha 2a Treatment in HBeAg Positive Chronic Hepatitis B Patients

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:
NCT02387463
First received: March 8, 2015
Last updated: August 17, 2016
Last verified: August 2016
  Purpose
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.

Condition
Chronic Hepatitis B

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of Extended Peginterferon Alpha 2a(PEG-IFN a-2a) Treatment in HBeAg Positive Chronic Hepatitis B Patients

Resource links provided by NLM:


Further study details as provided by Beijing Ditan Hospital:

Primary Outcome Measures:
  • rate of HBeAg seroconversion (defined as HBeAg loss with anti-HBe positive after PEG-IFN a-2a treatment and follow up) [ Time Frame: 120 weeks ]
    HBeAg seroconversion was defined as HBeAg loss with anti-HBe positive after PEG-IFN a-2a treatment and follow up.


Secondary Outcome Measures:
  • rate of HBsAg loss (defined as HBsAg level lower than 0.05 IU/ml) [ Time Frame: 96 weeks ]
    HBsAg loss was defined as HBsAg level lower than 0.05 IU/ml.

  • rate of sustained viral response (defined as serum HBV DNA undetectable at the end of treatment and the end of follow up) [ Time Frame: 120 weeks ]
    Sutained viral response was defined as serum HBV DNA undetectable at the end of treatment and the end of 24 weeks follow up.


Estimated Enrollment: 140
Study Start Date: March 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Detailed Description:
In this cohort study, the HBeAg positive chronic hepatitis B patients would be treated with peginterferon alpha 2a(PEG-IFN a-2a) for 96 week and followed 24 weeks after treatment. Serum HBV DNA load, HBsAg/anti-HBs level, HBeAg/anti-HBe will be tested at enrollment and every 3 months during treatment and follow period. Parameters of liver and kidney function, and liver ultrasound examination will be tested with intervals 1-3 months. The rates of HBeAg seroconversion, HBsAg loss, and sustained viral response will be evaluated after treatment and follow up.
  Eligibility

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 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.
Criteria

Inclusion Criteria:

  • HBeAg positive chronic hepatitis B patients

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: NCT02387463

Contacts
Contact: yao xie, MD 8610-84322489 xieyao00120184@sina.com

Locations
China, Beijing
Beijing Ditan hospital,Capital Medical University Recruiting
Beijing, Beijing, China, 100015
Contact: Yao Xie, doctor    8613501093293    xieyao00120184@sina.com   
Principal Investigator: Yao Xie, doctor         
Sponsors and Collaborators
Beijing Ditan Hospital
  More Information

Responsible Party: Yao Xie, liver diseases center, Beijing Ditan Hospital
ClinicalTrials.gov Identifier: NCT02387463     History of Changes
Other Study ID Numbers: DTXY008 
Study First Received: March 8, 2015
Last Updated: August 17, 2016

Keywords provided by Beijing Ditan Hospital:
chronic hepatitis B
antiviral therapy
peginterferon
HBeAg seroconversion
HBsAg loss

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
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on January 24, 2017