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Trial record 111 of 349 for:    hepatitis b | Open Studies

Sustained Viral Response in Patients Achieved HBsAg Level≤100 IU/ml After Completed Interferon Treatment

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:
NCT02348502
First received: January 22, 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). HBsAg loss/seroconversion is considered to be the ideal endpoint of antiviral therapy in both HBeAg-positive and -negative patients, and the ultimate treatment goal in CHB, However HBsAg loss occurred rarely by interferon treatment. Although It was reported that in nature history HBsAg level≤100 IU/ml can bring good long term outcomes in patients with chronic hepatitis B. it was not clear whether patients who achieved HBsAg level≤100 IU/ml by interferon treatment could maintain sustained viral response and the state of HBsAg level≤100 IU/ml.

Condition
Chronic Hepatitis B

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sustained Viral Response and HBsAg Level Changes in Chronic Hepatitis B Patients Who Achieved HBsAg Level≤100 IU/ml After Completed Interferon Therapy

Resource links provided by NLM:


Further study details as provided by Beijing Ditan Hospital:

Primary Outcome Measures:
  • the rate of sustained viral response [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    The serum HBV DNA will be tested every 3 month for 96 weeks after completed treatment in chronic hepatitis B patients who achieved serum HBsAg level≤100 IU/ml with HBV DNA undetectable by interferon therapy. The rate of sustained viral response defined HBV DNA level maintaining undetectable during observation period will be evaluated, and HBV reaction is defined as serum HBV DNA reverse back to detectable level.


Secondary Outcome Measures:
  • the rate of HBsAg loss [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
    The serum HBsAg level will be tested every 3 month after completed treatment. The rate of HBsAg loss defined as HBsAg level reached the value lower than the low limited value will be evaluated after 96 weeks follow-up.


Estimated Enrollment: 160
Study Start Date: January 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Detailed Description:
The patients with chronic hepatitis B and achieved HBsAg level≤100 IU/ml after completed interferon treatment will be enrolled and observed for 96 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 HBV DNA reaction. The secondary endpoints is HBsAg loss.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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 patients who had chronic hepatitis B and achieved HBsAg level≤100 IU/ml with undetectable HBV DNA level after interferon treatment, and serum HBsAg and HBV DNA would be tested every 3 months for 96 weeks after finished treatment. Sustained viral response defined as serum HBV DNA maintaining undetectable during the observation period. HBsAg loss is defined as HBsAg level reached the value lower than the low limited value.
Criteria

Inclusion Criteria:

  • patients who had chronic hepatitis B and achieved HBsAg level≤100 IU/ml with undetectable HBV DNA level 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: NCT02348502

Contacts
Contact: Yao Xie, MD 8610-84322489 xieyao00120184@sina.com

Locations
China, Beijing
liver disease center, Beijing Ditan Hospital Recruiting
Beijing, Beijing, China, 100015
Contact: Yao Xie, phD/MD    8610-84322200 ext 2489    xieyao@public.nta.net.cn   
Sponsors and Collaborators
Beijing Ditan Hospital
  More Information

Responsible Party: Yao Xie, liver diseases center, Beijing Ditan Hospital
ClinicalTrials.gov Identifier: NCT02348502     History of Changes
Other Study ID Numbers: DTXY003 
Study First Received: January 22, 2015
Last Updated: August 17, 2016
Health Authority: China: Beijing Municipal Science and Technology Commission

Keywords provided by Beijing Ditan Hospital:
HBsAg loss
interferon
HBV reaction
Hepatitis B

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 December 02, 2016