Chronic Hepatitis BNCT02412592
Sustained Viral Response in Chronic Hepatitis B Patients Who Achieved HBeAg Seroncongversion After Interferon Therapy
An observational study of Chronic Hepatitis B, run by Beijing Ditan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Hepatitis B
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- patients who achieved HBeAg seroconversion by interferon treatment.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yao Xie
Beijing, Beijing Municipality, 100015
Yao Xie, MD, 8610-8432220 ext. 2489, xieyao00120184@sina.com
About this study
Official title: Sustained Viral Response and Clincal Relapse in Chronic Hepatitis B Patients Who Achieved HBeAg Seroncongversion by Interferon Therapy
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.
Read the 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.
- Conditions
- Chronic Hepatitis B
- Keywords
- HBeAg positive, interferon, peginterferon, HBeAg seroconversion, sustained viral response, relapse
- Medical subject headings
- Hepatitis B, Chronic, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
sustained viral response
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.
Measured: 156 weeks
Secondary outcomes (2)
HBV DNA reaction
HBV DNA reaction was defined as HBV DNA load reverse back to detectable during observation period.
Measured: 156 weeks
clinical relapse
clinical relapse is defined as virla relapse with abnormal ALT during observation period
Measured: 156 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startJan 2013
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Ditan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yao Xie, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412592
- Sponsor's protocol ID
- DTXY009
- Status last verified
- Aug 2016
- First submitted
- 6 Apr 2015
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustained Viral Response and Clincal Relapse in Chronic Hepatitis B Patients Who Achieved HBeAg Seroncongversion by Interferon Therapy
- ClinicalTrials.gov ID
- NCT02412592
- Acronym / sponsor ID
- DTXY009
- Conditions
- Chronic Hepatitis B
- Keywords
- HBeAg positive, interferon, peginterferon, HBeAg seroconversion, sustained viral response, relapse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 9 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- patients who achieved HBeAg seroconversion by interferon treatment.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
HBV DNA reaction
Time frame: 156 weeks
clinical relapse
Time frame: 156 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis B, run by Beijing Ditan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yao xie, MD (8610-84322210 ext. 1489, xieyao00120184@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sustained viral response (time frame: 156 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2016.