Chronic Hepatitis bNCT04301908
A Cohort Study on Long-term Clinical Outcomes of Antiviral Therapy in Patients With Chronic Hepatitis B and Cirrhosis
An observational study of Chronic Hepatitis b, run by Beijing Ditan Hospital at 1 site in China.
Trial summary
This was a retrospective observational cohort study. The patients with chronic hepatitis B and cirrhosis who were treated with antiviral therapy in the Second Department of Liver Disease, Beijing Ditan Hospital, Capital Medical University from October 2008 to April 2020 were enrolled. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- interferon
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 1 Apr 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Antiviral therapy for patients with chronic hepatitis B and cirrhosis. Antiviral therapies included interferon and / or nucleoside (acid) analogs, and patients who were continuously treated for more than 6 months were included in the study. All patients with chronic hepatitis B and cirrhosis met the diagnostic criteria of China's Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015).
Who may be able to join
- Ages 18 to 75;
- Unlimited gender;
- Patients with chronic hepatitis B treated with interferon and / or nucleoside (acid) analogs (NA) antiviral therapy. All patients with chronic hepatitis B met the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015)
- No hormones and / or immunosuppressants and other hepatoprotective drugs;
- Sign a written informed consent.
Who cannot join
- Combined with other hepatitis virus (HCV, HDV) infections;
- Immune liver disease;
- HIV infection;
- long-term alcohol and / or other liver damage drugs;
- mental illness;
- Evidence of liver tumor (liver cancer or AFP> 100 ng / ml);
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- Decompensated cirrhosis;
- Those who have serious heart, brain, lung, kidney and other system diseases that cannot participate in long-term follow-up;
- There are hormones and / or immunosuppressants and other hepatoprotective drugs.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Hepatology Division 2, Beijing Ditan Hospital
Beijing, Beijing Municipality, 100015
About this study
Official title: The Observational Cohort Study on Long-term Clinical Outcomes of Antiviral Therapy in Patients With Chronic Hepatitis B and Cirrhosis
This was a retrospective observational cohort study. The patients with chronic hepatitis B and cirrhosis who were treated with antiviral therapy in the Second Department of Liver Disease, Beijing Ditan Hospital, Capital Medical University from October 2008 to April 2020 were enrolled. Patients treated with antiviral drugs including interferon and/or nucleoside (acid) analogues lasting more than 6 months were included in the study. Interferon, nucleoside (acid) analogue monotherapy, combination therapy, sequential therapy, maintenance therapy and drug withdrawal therapy can all be included in the study. HBV DNA content, HBsAg/anti-HBs, HBeAg/anti-HBe, biochemical indexes, serum AFP and liver imaging (liver ultrasound) were collected before treatment (baseline), during treatment and after treatment. The virological response and clinical outcome after antiviral treatment for chronic hepatitis B were observed for at least 288 weeks, and the main evaluation indicators were the occurrence or reversal of cirrhosis complications, hepatocellular carcinoma and mortality. Secondary evaluation index: the influence factors of different clinical outcomes. To investigate the long-term virological response and clinical outcome of antiviral therapy in patients with chronic hepatitis B and liver cirrhosis and to clarify its influencing factors.
Read the detailed description
This was a retrospective observational cohort study. The patients with chronic hepatitis B and cirrhosis who were treated with antiviral therapy in the Second Department of Liver Disease, Beijing Ditan Hospital, Capital Medical University from October 2008 to April 2020 were enrolled. Patients treated with antiviral drugs including interferon and/or nucleoside (acid) analogues lasting more than 6 months were included in the study. Interferon, nucleoside (acid) analogue monotherapy, combination therapy, sequential therapy, maintenance therapy and drug withdrawal therapy can all be included in the study. HBV DNA content, HBsAg/anti-HBs, HBeAg/anti-HBe, biochemical indexes, serum AFP and liver imaging (liver ultrasound) were collected before treatment (baseline), during treatment and after treatment. The virological response and clinical outcome after antiviral treatment for chronic hepatitis B were observed for at least 288 weeks, and the main evaluation indicators were the occurrence or reversal of cirrhosis complications, hepatocellular carcinoma and mortality. Secondary evaluation index: the influence factors of different clinical outcomes. To investigate the long-term virological response and clinical outcome of antiviral therapy in patients with chronic hepatitis B and liver cirrhosis and to clarify its influencing factors.
- Conditions
- Chronic Hepatitis b
- Being tested
- interferon
- Keywords
- Chronic hepatitis B, Interferon, Nucleoside (acid) analogs, HBV DNA, Hepatitis B surface antigen, Hepatocellular carcinoma
- Medical subject headings
- Hepatitis B, Chronic, Heartburn, Hepatitis B, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interferonDrug
Also called nucleoside (acid) analogues
Antiviral therapy for patients with chronic hepatitis B and cirrhosis. Antiviral therapies included interferon and / or nucleoside (acid) analogs, and patients who were continuously treated for more than 6 months were included in the study.
| Study group | Role | What they receive |
|---|---|---|
| antiviral therapy group | Patients with chronic hepatitis B and cirrhosis were treated with antiviral drugs Receives: Drug: interferon |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of incidence or reversal of cirrhosis comorbidities, liver cancer, and the incidence of death
The incidence or reversal of cirrhosis comorbidities, the incidence of liver cancer, and the incidence of death
Measured: 288 weeks after antiviral therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Apr 2020 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Apr 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
- Retrospective
- Enrolment
- 10,000 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
- NCT04301908
- Sponsor's protocol ID
- DTXY024
- Status last verified
- Mar 2020
- First submitted
- 5 Mar 2020
- Last updated
- 10 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deng W, Chen X, Zhang Z, Li X, Cao W, Zhang Y, Wang S, Yao L, Wei X, Wang S, Gao Z, Xie Y, Li M. Association between changes in HBsAb levels and hepatic adverse events after HBsAg clearance in non-cirrhotic chronic hepatitis B patients. BMC Infect Dis. 2026 Jun 26. doi: 10.1186/s12879-026-13791-9. Online ahead of print.
PubMed 42350969
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Observational Cohort Study on Long-term Clinical Outcomes of Antiviral Therapy in Patients With Chronic Hepatitis B and Cirrhosis
- ClinicalTrials.gov ID
- NCT04301908
- Acronym / sponsor ID
- DTXY024
- Conditions
- Chronic Hepatitis b
- Keywords
- Chronic hepatitis B, Interferon, Nucleoside (acid) analogs, HBV DNA, Hepatitis B surface antigen, Hepatocellular carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 10 Mar 2020 (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.
This was a retrospective observational cohort study. The patients with chronic hepatitis B and cirrhosis who were treated with antiviral therapy in the Second Department of Liver Disease, Beijing Ditan Hospital, Capital Medical University from October 2008 to April 2020 were enrolled. Patients treated with antiviral drugs including interferon and/or nucleoside (acid) analogues lasting more than 6 months were included in the study. Interferon, nucleoside (acid) analogue monotherapy, combination therapy, sequential therapy, maintenance therapy and drug withdrawal therapy can all be included in the study. HBV DNA content, HBsAg/anti-HBs, HBeAg/anti-HBe, biochemical indexes, serum AFP and liver imaging (liver ultrasound) were collected before treatment (baseline), during treatment and after treatment. The virological response and clinical outcome after antiviral treatment for chronic hepatitis B were observed for at least 288 weeks, and the main evaluation indicators were the occurrence or reversal of cirrhosis complications, hepatocellular carcinoma and mortality. Secondary evaluation index: the influence factors of different clinical outcomes. To investigate the long-term virological response and clinical outcome of antiviral therapy in patients with chronic hepatitis B and liver cirrhosis and to clarify its influencing factors.
Detailed description
This was a retrospective observational cohort study. The patients with chronic hepatitis B and cirrhosis who were treated with antiviral therapy in the Second Department of Liver Disease, Beijing Ditan Hospital, Capital Medical University from October 2008 to April 2020 were enrolled. Patients treated with antiviral drugs including interferon and/or nucleoside (acid) analogues lasting more than 6 months were included in the study. Interferon, nucleoside (acid) analogue monotherapy, combination therapy, sequential therapy, maintenance therapy and drug withdrawal therapy can all be included in the study. HBV DNA content, HBsAg/anti-HBs, HBeAg/anti-HBe, biochemical indexes, serum AFP and liver imaging (liver ultrasound) were collected before treatment (baseline), during treatment and after treatment. The virological response and clinical outcome after antiviral treatment for chronic hepatitis B were observed for at least 288 weeks, and the main evaluation indicators were the occurrence or reversal of cirrhosis complications, hepatocellular carcinoma and mortality. Secondary evaluation index: the influence factors of different clinical outcomes. To investigate the long-term virological response and clinical outcome of antiviral therapy in patients with chronic hepatitis B and liver cirrhosis and to clarify its influencing factors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| antiviral therapy group | – | Drug: interferonPatients with chronic hepatitis B and cirrhosis were treated with antiviral drugs |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Antiviral therapy for patients with chronic hepatitis B and cirrhosis. Antiviral therapies included interferon and / or nucleoside (acid) analogs, and patients who were continuously treated for more than 6 months were included in the study. All patients with chronic hepatitis B and cirrhosis met the diagnostic criteria of China's Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015).
Key inclusion criteria (5 listed)
- Ages 18 to 75;
- Unlimited gender;
- Patients with chronic hepatitis B treated with interferon and / or nucleoside (acid) analogs (NA) antiviral therapy. All patients with chronic hepatitis B met the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015)
- No hormones and / or immunosuppressants and other hepatoprotective drugs;
- Sign a written informed consent.
Key exclusion criteria (9 listed)
- Combined with other hepatitis virus (HCV, HDV) infections;
- Immune liver disease;
- HIV infection;
- long-term alcohol and / or other liver damage drugs;
- mental illness;
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 |
|---|---|---|
| interferonAlso: nucleoside (acid) analoguesAntiviral therapy for patients with chronic hepatitis B and cirrhosis. Antiviral therapies included interferon and / or nucleoside (acid) analogs, and patients who were continuously treated for more than 6 months were included in the study. | Drug | antiviral therapy group |
Primary outcome
The rate of incidence or reversal of cirrhosis comorbidities, liver cancer, and the incidence of death
Time frame: 288 weeks after antiviral therapy
The incidence or reversal of cirrhosis comorbidities, the incidence of liver cancer, and the incidence of death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Derived from this study: PubMed 42350969Deng W, Chen X, Zhang Z, Li X, Cao W, Zhang Y, Wang S, Yao L, Wei X, Wang S, Gao Z, Xie Y, Li M. Association between changes in HBsAb levels and hepatic adverse events after HBsAg clearance in non-cirrhotic chronic hepatitis B patients. BMC Infect Dis. 2026 Jun 26. doi: 10.1186/s12879-026-13791-9. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 5 inclusion and 9 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 10 Mar 2020. 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 incidence or reversal of cirrhosis comorbidities, liver cancer, and the incidence of death (time frame: 288 weeks after antiviral therapy). 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 NCT04301908, 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 10 Mar 2020.