Chronic Hepatitis BNCT02336399
Sustained HBsAg and Viral Response in Patients Achieved HBsAg Loss by Interferon Treatment
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).HBsAg loss/seroconversion is considered to be the ideal endpoint of antiviral therapy in both HBeAg-positive and HBeAg-negative patients, as well as the ultimate treatment goal in CHB. Read more about this study
- Who is it for?
- Ages 2 to 75 years
- Conditions the study is for
- Chronic Hepatitis B
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- Sep 2008to Dec 2021
- 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 2 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population in this study is composed of patients who have chronic hepatitis B and achieved HBsAg loss from interferon treatment. Eligible patients will have serum HBsAg and HBV DNA tests every 3 months for 96 weeks after finishing the interferon treatment. The sustained HBsAg response is defined as the levels of serum HBsAg mantaining below the low level of quantitation and the levels of HBV DNA remain undetectable. Following the completion of the study period, patients will be offered to participate in a long term study for further observation up to 240 weeks.
Who may be able to join
- Patients who had chronic hepatitis B and achieved HBsAg loss 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
Beijing Ditan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100015
About this study
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 HBeAg-negative patients, as well as the ultimate treatment goal in CHB. However, some patients who have achieved HBsAg loss would reverse back to HBsAg positive, or even become HBV reactive with recurrence of viremia. In current study, the viral and HBsAg response in patients who have achieved HBsAg loss by interferon (IFN) treatment will be observed for 96 weeks after the completion of IFN treatment. The primary analysis will be performed at the end of 96 weeks. Following the completion of the study period of 96 weeks, patients will be offered to participate in a long term study for further observation of additional 144 weeks (total of 240 weeks from the enrollment).
Read the detailed description
Chronic hepatitis B patients who have achieved HBsAg loss from 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. Their liver function and chemistry tests are also performed every 3 months. The liver ultrasonic examination would be taken every 3-6 months. The primary measurement is the percentage of patients who have positive HBsAg and/or a detectable level of HBV DNA. Following the completion of the study period, patients will be offered to participate in a long term study for further observation of additional 144 weeks.
- Conditions
- Chronic Hepatitis B
- Keywords
- HBsAg loss, interferon, HBV reaction
- Medical subject headings
- Hepatitis B, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of sustained HBsAg negativity and viral response in 96 weeks
The percentage of patients who have both undetectable level of HBsAg and undetectable level of serum HBV DNA at 96 weeks after completing treatment with interferon
Measured: From the enrollment to 96 weeks
Secondary outcomes (5)
The rate of sustained HBsAg negativity and viral response in long term
The percentage of patients who have both undetectable level of HBsAg and undetectable level of serum HBV DNA at 240 weeks after completing treatment with interferon
Measured: From the enrollment to 240 weeks
The rate of sustained HBsAg negativity and viral response in subset analysis in 96 weeks
The percentage of patients who have both undetectable level of HBsAg and undetectable level of serum HBV DNA at 96 weeks after completing treatment with interferon mono-therapy versus those who have the same endpoints after the completion of the interferon therapy in the combination or sequencing of oral antiviral therapy
Measured: From the enrollment to 96 weeks
The rate of sustained HBsAg negativity and viral response in subset analysis for long term
The percentage of patients who have both undetectable level of HBsAg and undetectable level of serum HBV DNA at 240 weeks after completing treatment with interferon mono-therapy versus those who have the same endpoints after completing the interferon therapy in the combination or sequencing of oral antiviral therapy
Measured: From the enrollment to 240 weeks
Predictor(s) for recurrence of HBsAg positivity or detectable levels of HBV DNA in 96 weeks
Clinical features and baseline factors will be analyzed by comparing patients who have sustained HBsAg negativity and viral response vs. those who have no sustained endpoints at week 96.
Measured: From the enrollment to 96 weeks
Predictor(s) for recurrence of HBsAg positivity or detectable levels of HBV DNA in long term
Clinical features and baseline factors will be analyzed by comparing patients who have sustained HBsAg negativity and viral response vs. those who have no sustained endpoints at week 240.
Measured: From the enrollment to 240 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startSep 2008
- Primary completionDec 2016
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Ditan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yao Xie, Beijing Ditan Hospital
- Investigators
- Yao Xie, MD, Principal investigator, Beijing Ditan Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336399
- Sponsor's protocol ID
- DTXY002
- Status last verified
- Nov 2017
- First submitted
- 8 Jan 2015
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Pan CQ, Li MH, Yi W, Zhang L, Lu Y, Hao HX, Wan G, Cao WH, Wang XY, Ran CP, Shen G, Wu SL, Chang M, Gao YJ, Xie Y. Outcome of Chinese patients with hepatitis B at 96 weeks after functional cure with IFN versus combination regimens. Liver Int. 2021 Jul;41(7):1498-1508. doi: 10.1111/liv.14801. Epub 2021 Feb 16.
PubMed 33486874
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustained HBsAg and Viral Response in Patients Achieved HBsAg Loss by Interferon Treatment
- ClinicalTrials.gov ID
- NCT02336399
- Acronym / sponsor ID
- DTXY002
- Conditions
- Chronic Hepatitis B
- Keywords
- HBsAg loss, interferon, HBV reaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Study start
- Sep 2008 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 13 Jan 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).HBsAg loss/seroconversion is considered to be the ideal endpoint of antiviral therapy in both HBeAg-positive and HBeAg-negative patients, as well as the ultimate treatment goal in CHB. However, some patients who have achieved HBsAg loss would reverse back to HBsAg positive, or even become HBV reactive with recurrence of viremia. In current study, the viral and HBsAg response in patients who have achieved HBsAg loss by interferon (IFN) treatment will be observed for 96 weeks after the completion of IFN treatment. The primary analysis will be performed at the end of 96 weeks. Following the completion of the study period of 96 weeks, patients will be offered to participate in a long term study for further observation of additional 144 weeks (total of 240 weeks from the enrollment).
Detailed description
Chronic hepatitis B patients who have achieved HBsAg loss from 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. Their liver function and chemistry tests are also performed every 3 months. The liver ultrasonic examination would be taken every 3-6 months. The primary measurement is the percentage of patients who have positive HBsAg and/or a detectable level of HBV DNA. Following the completion of the study period, patients will be offered to participate in a long term study for further observation of additional 144 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population in this study is composed of patients who have chronic hepatitis B and achieved HBsAg loss from interferon treatment. Eligible patients will have serum HBsAg and HBV DNA tests every 3 months for 96 weeks after finishing the interferon treatment. The sustained HBsAg response is defined as the levels of serum HBsAg mantaining below the low level of quantitation and the levels of HBV DNA remain undetectable. Following the completion of the study period, patients will be offered to participate in a long term study for further observation up to 240 weeks.
Key inclusion criteria (1 listed)
- Patients who had chronic hepatitis B and achieved HBsAg loss 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
The rate of sustained HBsAg negativity and viral response in 96 weeks
Time frame: From the enrollment to 96 weeks
The percentage of patients who have both undetectable level of HBsAg and undetectable level of serum HBV DNA at 96 weeks after completing treatment with interferon
5 secondary outcomes
The rate of sustained HBsAg negativity and viral response in long term
Time frame: From the enrollment to 240 weeks
The rate of sustained HBsAg negativity and viral response in subset analysis in 96 weeks
Time frame: From the enrollment to 96 weeks
The rate of sustained HBsAg negativity and viral response in subset analysis for long term
Time frame: From the enrollment to 240 weeks
Predictor(s) for recurrence of HBsAg positivity or detectable levels of HBV DNA in 96 weeks
Time frame: From the enrollment to 96 weeks
Predictor(s) for recurrence of HBsAg positivity or detectable levels of HBV DNA in long term
Time frame: From the enrollment to 240 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Derived from this study: PubMed 33486874Pan CQ, Li MH, Yi W, Zhang L, Lu Y, Hao HX, Wan G, Cao WH, Wang XY, Ran CP, Shen G, Wu SL, Chang M, Gao YJ, Xie Y. Outcome of Chinese patients with hepatitis B at 96 weeks after functional cure with IFN versus combination regimens. Liver Int. 2021 Jul;41(7):1498-1508. doi: 10.1111/liv.14801. Epub 2021 Feb 16.
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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.
Yao Xie, MD principal investigator
Beijing Ditan Hospital, Beijing, China
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 14 Nov 2017. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of sustained HBsAg negativity and viral response in 96 weeks (time frame: From the enrollment to 96 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02336399, which also lists 1 linked publication.
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 14 Nov 2017.