Chronic Hepatitis B InfectionNCT04030039
Cohort Study of Clinical Outcomes in Chronic HBV Infection Patients With Low HBsAg Under Unplanned Intervention
An observational study of Chronic Hepatitis B Infection, run by Beijing Ditan Hospital at 1 site in China.
Trial summary
All chronic hepatitis B (CHB) patients were diagnosed and treated in the liver disease department of the Hepatology Center of Beijing Ditan Hospital affiliated to Capital Medical University and those who received antiviral therapy (interferon and nucleoside analogues) reached HBsAg<100 IU/ml. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Chronic Hepatitis B Infection
- What is being tested?
- Interferon and nucleoside analogues
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 30 Dec 2020
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic hepatitis B patients with HBsAg < 100 IU/ml in an inactive carrying state were enrolled and treated with antiviral therapy (interferon and nucleoside analogs). All patients with chronic hepatitis B infection were eligible for the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015).
Who may be able to join
- Inactive carrier status and chronic hepatitis B (CHB) patients with anti-viral therapy (interferon and nucleoside analogues) reaching HBsAg < 100 IU/ml.
Who cannot join
- coinfection with other viruses including HCV, HDV, and HIV;
- syphilis antibody positive;
- co-exist other liver diseases including alcoholic liver disease, metabolic liver disease, fatty liver, drug induce liver injury, and autoimmune liver disease;
- complication of cirrhosis or liver cancer.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
liver disease center, Beijing Ditan Hospital
Beijing, Beijing Municipality, 100015
Yao Xie, phD/MD, 8610-84322200 ext. 2489, xieyao@public.nta.net.cn
About this study
Official title: Cohort Study of Clinical Outcomes in Chronic HBV Infection Patients With Low HBsAg Loads Under Unplanned Intervention
All chronic hepatitis B (CHB) patients were diagnosed and treated in the liver disease department of the Hepatology Center of Beijing Ditan Hospital affiliated to Capital Medical University and those who received antiviral therapy (interferon and nucleoside analogues) reached HBsAg<100 IU/ml. The enrolled subjects were divided into the following six observation cohorts: 1) CHB patients in the immunological control period, without any clinical treatment intervention; 2) After interferon therapy, HBsAg<100 IU/ml, continued interferon therapy; 3) After interferon therapy, HBsAg<100 IU/ml, stopped interferon treatment; 4) After interferon therapy, HBsAg<100 IU/ml, sequential nucleoside analog treatment; 5) After nucleoside analogue treatment, HBsAg<100 IU/ml, sequential interferon treatment; 6) After treated with nucleoside analogues, HBsAg<100 IU/ml, continuing the nucleoside analog treatment. The follow-up observation period was 96 weeks under non-planned intervention. During the observation period, HBV indicators and biochemical indicators, serum AFP and liver imaging (liver ultrasound) were examined regularly. The main evaluation index was the incidence of HBsAg disappearance during the observation period. Secondary evaluation indicators: the rate of HBV DNA turning positive, the rate of HBeAg turning positive and hepatitis incidence. To observe the inactive carrier status of low HBsAg content and the incidence of HBsAg disappearance, clinical outcomes and influencing factors in patients with CHB under different antiviral interventions.
Read the detailed description
This study is a clinical observational cohort study. All chronic hepatitis B patients were diagnosed and treated in the liver disease department of the Hepatology Center of Beijing Ditan Hospital affiliated to Capital Medical University and those who received antiviral therapy (interferon and nucleoside analogues) reached HBsAg<100 IU/ml. The enrolled subjects were divided into the following six observation cohorts: 1) chronic Hepatitis B patients in the immunological control period, without any clinical treatment intervention in this cohort; 2) After interferon therapy, HBsAg<100 IU/ml, continued interferon therapy in this cohort; 3) After interferon therapy, HBsAg<100 IU/ml, stopped interferon treatment in this cohort; 4) After interferon therapy, HBsAg<100 IU/ml, sequential nucleoside analog treatment in this cohort; 5) After nucleoside analogue treatment, HBsAg<100 IU/ml, sequential interferon treatment in this cohort; 6) After treated with nucleoside analogues, HBsAg<100 IU/ml, continuing the nucleoside analog treatment in this cohort. The follow-up observation period was 96 weeks under non-planned intervention. During the observation period, HBV DNA loads, HBsAg/anti-HBs, HBeAg/anti-HBe and biochemical indicators, serum AFP and liver imaging (liver ultrasound) were examined regularly. The main evaluation index was the incidence of HBsAg disappearance during the observation period. Secondary evaluation indicators: the rate of HBV DNA turning positive, the rate of HBeAg turning positive and hepatitis incidence. To observe the inactive carrier status of low HBsAg content and the incidence of HBsAg disappearance, clinical outcomes and influencing factors in patients with CHB under different antiviral interventions.
- Conditions
- Chronic Hepatitis B Infection
- Being tested
- Interferon, nucleoside analogues
- Keywords
- Chronic hepatitis B, interferon, nucleotide, HBV, HBsAg, HBV DNA
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterferonDrug
chronic hepatitis B patients with interferon therapy
nucleoside analoguesDrug
chronic hepatitis B patients with interferon therapy
| Study group | Role | What they receive |
|---|---|---|
| chronic hepatitis B patients during the immune control period | Patients with chronic HBV infection during the immune control period do not have any clinical treatment intervention cohort | |
| Therapy group A | After chronic hepatitis B patients were treated with interferon, HBsAg level of these patients < 100 IU / ml, and they continued to be treated with interferon Receives: Drug: Interferon | |
| Therapy group B | After chronic hepatitis B patients were treated with interferon, HBsAg level of these patients < 100 IU / ml, and they stopped to be treated with interferon Receives: Drug: Interferon | |
| Therapy group C | After chronic hepatitis B patients were treated with interferon, HBsAg level of these patients < 100 IU / ml, and they continued to be treated with sequential nucleoside analogues Receives: Drug: Interferon; Drug: nucleoside analogues | |
| Therapy group D | After chronic hepatitis B patients were treated with nucleoside analogues, HBsAg level of these patients < 100 IU / ml, and they continued to be treated with sequential interferon Receives: Drug: Interferon; Drug: nucleoside analogues | |
| Therapy group E | After chronic hepatitis B patients were treated with nucleoside analogues, HBsAg level of these patients < 100 IU / ml, and they continued to be treated with the nucleoside analogues Receives: Drug: nucleoside analogues |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of HBsAg disappearance during the 96-week study in different observation cohorts
The incidence of HBsAg disappearance during the 96-week study in different observation cohorts
Measured: 96 weeks
Secondary outcomes (2)
HBV DNA re-yang rate during the 96-week study period in different observation cohorts
HBV DNA re-yang rate and HBeAg re-yang rate during the 96-week study period in different observation cohorts
Measured: 96 weeks
HBeAg re-yang rate during the 96-week study
HBeAg re-yang rate during the 96-week study
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start1 May 2017
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B InfectionStudies 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 (estimated)
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, Principal investigator, Beijing Ditan Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030039
- Sponsor's protocol ID
- DTXY017
- Status last verified
- Jul 2019
- First submitted
- 22 Jun 2019
- Last updated
- 23 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Clinical Outcomes in Chronic HBV Infection Patients With Low HBsAg Loads Under Unplanned Intervention
- ClinicalTrials.gov ID
- NCT04030039
- Acronym / sponsor ID
- DTXY017
- Conditions
- Chronic Hepatitis B Infection
- Keywords
- Chronic hepatitis B, interferon, nucleotide, HBV, HBsAg, HBV DNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 23 Jul 2019 (actual)
- 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.
All chronic hepatitis B (CHB) patients were diagnosed and treated in the liver disease department of the Hepatology Center of Beijing Ditan Hospital affiliated to Capital Medical University and those who received antiviral therapy (interferon and nucleoside analogues) reached HBsAg<100 IU/ml. The enrolled subjects were divided into the following six observation cohorts: 1) CHB patients in the immunological control period, without any clinical treatment intervention; 2) After interferon therapy, HBsAg<100 IU/ml, continued interferon therapy; 3) After interferon therapy, HBsAg<100 IU/ml, stopped interferon treatment; 4) After interferon therapy, HBsAg<100 IU/ml, sequential nucleoside analog treatment; 5) After nucleoside analogue treatment, HBsAg<100 IU/ml, sequential interferon treatment; 6) After treated with nucleoside analogues, HBsAg<100 IU/ml, continuing the nucleoside analog treatment. The follow-up observation period was 96 weeks under non-planned intervention. During the observation period, HBV indicators and biochemical indicators, serum AFP and liver imaging (liver ultrasound) were examined regularly. The main evaluation index was the incidence of HBsAg disappearance during the observation period. Secondary evaluation indicators: the rate of HBV DNA turning positive, the rate of HBeAg turning positive and hepatitis incidence. To observe the inactive carrier status of low HBsAg content and the incidence of HBsAg disappearance, clinical outcomes and influencing factors in patients with CHB under different antiviral interventions.
Detailed description
This study is a clinical observational cohort study. All chronic hepatitis B patients were diagnosed and treated in the liver disease department of the Hepatology Center of Beijing Ditan Hospital affiliated to Capital Medical University and those who received antiviral therapy (interferon and nucleoside analogues) reached HBsAg<100 IU/ml. The enrolled subjects were divided into the following six observation cohorts: 1) chronic Hepatitis B patients in the immunological control period, without any clinical treatment intervention in this cohort; 2) After interferon therapy, HBsAg<100 IU/ml, continued interferon therapy in this cohort; 3) After interferon therapy, HBsAg<100 IU/ml, stopped interferon treatment in this cohort; 4) After interferon therapy, HBsAg<100 IU/ml, sequential nucleoside analog treatment in this cohort; 5) After nucleoside analogue treatment, HBsAg<100 IU/ml, sequential interferon treatment in this cohort; 6) After treated with nucleoside analogues, HBsAg<100 IU/ml, continuing the nucleoside analog treatment in this cohort. The follow-up observation period was 96 weeks under non-planned intervention. During the observation period, HBV DNA loads, HBsAg/anti-HBs, HBeAg/anti-HBe and biochemical indicators, serum AFP and liver imaging (liver ultrasound) were examined regularly. The main evaluation index was the incidence of HBsAg disappearance during the observation period. Secondary evaluation indicators: the rate of HBV DNA turning positive, the rate of HBeAg turning positive and hepatitis incidence. To observe the inactive carrier status of low HBsAg content and the incidence of HBsAg disappearance, clinical outcomes and influencing factors in patients with CHB under different antiviral interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| chronic hepatitis B patients during the immune control period | – | –Patients with chronic HBV infection during the immune control period do not have any clinical treatment intervention cohort |
| Therapy group A | – | Drug: InterferonAfter chronic hepatitis B patients were treated with interferon, HBsAg level of these patients < 100 IU / ml, and they continued to be treated with interferon |
| Therapy group B | – | Drug: InterferonAfter chronic hepatitis B patients were treated with interferon, HBsAg level of these patients < 100 IU / ml, and they stopped to be treated with interferon |
| Therapy group C | – | Drug: Interferon, Drug: nucleoside analoguesAfter chronic hepatitis B patients were treated with interferon, HBsAg level of these patients < 100 IU / ml, and they continued to be treated with sequential nucleoside analogues |
| Therapy group D | – | Drug: Interferon, Drug: nucleoside analoguesAfter chronic hepatitis B patients were treated with nucleoside analogues, HBsAg level of these patients < 100 IU / ml, and they continued to be treated with sequential interferon |
| Therapy group E | – | Drug: nucleoside analoguesAfter chronic hepatitis B patients were treated with nucleoside analogues, HBsAg level of these patients < 100 IU / ml, and they continued to be treated with the nucleoside analogues |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic hepatitis B patients with HBsAg < 100 IU/ml in an inactive carrying state were enrolled and treated with antiviral therapy (interferon and nucleoside analogs). All patients with chronic hepatitis B infection were eligible for the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015).
Key inclusion criteria (1 listed)
- Inactive carrier status and chronic hepatitis B (CHB) patients with anti-viral therapy (interferon and nucleoside analogues) reaching HBsAg < 100 IU/ml.
Key exclusion criteria (4 listed)
- coinfection with other viruses including HCV, HDV, and HIV;
- syphilis antibody positive;
- co-exist other liver diseases including alcoholic liver disease, metabolic liver disease, fatty liver, drug induce liver injury, and autoimmune liver disease;
- complication of cirrhosis or liver cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferonchronic hepatitis B patients with interferon therapy | Drug | Therapy group A, Therapy group B, Therapy group C, Therapy group D |
| nucleoside analogueschronic hepatitis B patients with interferon therapy | Drug | Therapy group C, Therapy group D, Therapy group E |
Primary outcome
The incidence of HBsAg disappearance during the 96-week study in different observation cohorts
Time frame: 96 weeks
The incidence of HBsAg disappearance during the 96-week study in different observation cohorts
2 secondary outcomes
HBV DNA re-yang rate during the 96-week study period in different observation cohorts
Time frame: 96 weeks
HBeAg re-yang rate during the 96-week study
Time frame: 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
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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 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 Infection, 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 4 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 23 Jul 2019. 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, Doctor (010-84322284, xieyao00120184@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of HBsAg disappearance during the 96-week study in different observation cohorts (time frame: 96 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 23 Jul 2019.