Chronic Hepatitis BNCT05792878
Study of COVID-19 Infection and Its Clinical Prognosis in Chronic Hepatitis B Patients With Antiviral Therapy
An observational study of Chronic Hepatitis B and COVID-19 Infection, run by Beijing Ditan Hospital at 1 site in China.
Trial summary
This is a two-way (retrospective and prospective) study of COVID-19 infection in an observational cohort of patients with chronic hepatitis B treated with antiviral therapy. Patients with chronic hepatitis B who received anti-HBV treatment in the Second Department of Hepatology, Beijing Ditan Hospital Affiliated to… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis B, COVID-19 Infection
- What is being tested?
- Interferon and nucleoside analogues
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 1 Dec 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: During 48 weeks of the prospective observation period, the treated patients continuously use the original treatment. After the initial treatment patients are enrolled, they receive antiviral treatment with interferon or nucleoside analogues according to the needs of the disease. During the treatment period, the corresponding virology, serology, clinical biochemistry and liver imaging examinations of hepatitis B antiviral treatment were carried out every 3-6 months. During COVID-19 infection, the patient shall be checked for clinical symptoms, clinical biochemistry, blood routine, pulmonary imaging, COVID-19 and antibodies, as well as other organs and functional indicators required by clinical needs.
Who may be able to join
- 1) HBsAg positive for 6 months.
- 2) Patients undergoing initial or ongoing antiviral treatment.
- 3) HBeAg status and HBV DNA level are not limited.
Who cannot join
- 1) Patients with decompensated liver cirrhosis or previous decompensated liver cirrhosis.
- 2) At the same time, it is associated with other viral infections, such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, HIV, etc. - 3) Accompanied with other serious physical and mental diseases, including uncontrolled primary kidney, heart, lung, vascular, nervous, digestive, severe metabolic diseases (such as uncontrolled hyperthyroidism, diabetes, serious complications, adrenal diseases, etc.), immunodeficiency disease, and accompanied with serious infection; History of active or suspected malignant tumors or malignant tumors.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Hepatology Division 2, Beijing Ditan Hospital
Beijing, Beijing Municipality, 100015
Yao Xie, Doctor, 8610-84322200 ext. 2489, xieyao00120184@sina.com
About this study
Official title: The Observational Study of COVID-19 Infection and Its Clinical Prognosis in Chronic Hepatitis B Patients With Antiviral Therapy
This is a two-way (retrospective and prospective) study of COVID-19 infection in an observational cohort of patients with chronic hepatitis B treated with antiviral therapy. Patients with chronic hepatitis B who received anti-HBV treatment in the Second Department of Hepatology, Beijing Ditan Hospital Affiliated to Capital Medical University from February 2022 to December 2023 were enrolled. After enrollment, demographic data of patients, information on antiviral treatment of chronic hepatitis B, COVID-19 vaccination, COVID-19 infection and COVID-19 incidence and treatment from January 2022 to pre enrollment, and data on HBV virus and serology, clinical biochemistry, liver and lung imaging, COVID-19 nucleic acid and COVID-19 antibody examination of patients were collected. After enrollment, prospective anti-HBV treatment, HBV virology, clinical biochemistry, liver imaging and COVID-19 infection and morbidity were observed. The patients with COVID-19 infection during the prospective observation period were observed for COVID-19 infection, onset and treatment, including body temperature, clinical symptoms, signs, cardiac examination, pulmonary imaging, COVID-19, clinical biochemistry, disease severity, time of virus negative conversion, hospital stay and outcome. The influence of COVID-19 infection on liver disease and the influence of interferon anti-HBV treatment on COVID-19 infection, its pathogenesis and prognosis were studied.
Read the detailed description
This is a two-way (retrospective+prospective) study of COVID-19 infection in an observational cohort of patients with chronic hepatitis B treated with antiviral therapy. Patients with chronic hepatitis B who received anti-HBV treatment in the Department of Hepatology Division 2, Beijing Ditan Hospital, Capital Medical University from February 2022 to December 2023 were enrolled. After enrollment, demographic data of patients, information on antiviral treatment of chronic hepatitis B, COVID-19 vaccination, COVID-19 infection and COVID-19 incidence and treatment from January 2022 to pre enrollment, and data on hepatitis B virus and serology, clinical biochemistry, liver and lung imaging, COVID-19 nucleic acid and COVID-19 antibody examination of patients were collected. After enrollment, prospective anti hepatitis B virus treatment, HBV virology, clinical biochemistry, liver imaging and COVID-19 infection and morbidity were observed. The patients with COVID-19 infection during the prospective observation period were observed for COVID-19 infection, onset and treatment, including body temperature, clinical symptoms, signs, cardiac examination, pulmonary imaging, COVID-19, clinical biochemistry, disease severity, time of virus negative conversion, hospital stay and outcome. The influence of COVID-19 infection on liver disease and the influence of interferon anti hepatitis B virus treatment on COVID-19 infection, its pathogenesis and prognosis were explored.
- Conditions
- Chronic Hepatitis B, COVID-19 Infection
- Being tested
- Interferon, nucleoside analogues
- Keywords
- chronic hepatitis, COVID-19 infection, interferon
- Medical subject headings
- Hepatitis B, Chronic, COVID-19, Hepatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterferonDrug
Also called peg-interferon alpha
The naive treated patients with chronic hepatitis B were given antiviral treatment with interferon according to their condition.
nucleoside analoguesDrug
Also called NAs
The naive treated patients with chronic hepatitis B were given antiviral treatment with nucleoside analogues according to their condition.
| Study group | Role | What they receive |
|---|---|---|
| Interferon treatment group | Patients with chronic hepatitis B who received antiviral treatment with Interferon at the Second Department of Hepatology, Beijing Ditan Hospital Affiliated to Capital Medical University from February 2022 to December 2023 were enrolled. Receives: Drug: Interferon | |
| nucleoside analogues treatment group | Patients with chronic hepatitis B who received antiviral treatment with nucleoside analogues at the Second Department of Hepatology, Beijing Ditan Hospital Affiliated to Capital Medical University from February 2022 to December 2023 were enrolled Receives: Drug: nucleoside analogues |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of COVID-19 infection.
The rate of chronic hepatitis B patients infected with COVID-19 after initial antiviral treatment.
Measured: 48 weeks after therapy
Secondary outcomes (2)
The rate of severe disease after COVID-19 infection.
The rate of severe disease after COVID-19 infection for chronic hepatitis B patients after initial antiviral treatment.
Measured: 48 weeks after therapy
The hospitalization rate and duration of COVID-19.
The hospitalization rate and duration of COVID-19 for chronic hepatitis B patients after initial antiviral treatment.
Measured: 48 weeks after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start1 Sep 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (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
- 600 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, Doctor, Principal investigator, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792878
- Sponsor's protocol ID
- DTXY26
- Status last verified
- Mar 2023
- First submitted
- 28 Mar 2023
- Last updated
- 31 Mar 2023
- 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 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Observational Study of COVID-19 Infection and Its Clinical Prognosis in Chronic Hepatitis B Patients With Antiviral Therapy
- ClinicalTrials.gov ID
- NCT05792878
- Acronym / sponsor ID
- DTXY26
- Conditions
- Chronic Hepatitis B, COVID-19 Infection
- Keywords
- chronic hepatitis, COVID-19 infection, interferon
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 31 Mar 2023 (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 is a two-way (retrospective and prospective) study of COVID-19 infection in an observational cohort of patients with chronic hepatitis B treated with antiviral therapy. Patients with chronic hepatitis B who received anti-HBV treatment in the Second Department of Hepatology, Beijing Ditan Hospital Affiliated to Capital Medical University from February 2022 to December 2023 were enrolled. After enrollment, demographic data of patients, information on antiviral treatment of chronic hepatitis B, COVID-19 vaccination, COVID-19 infection and COVID-19 incidence and treatment from January 2022 to pre enrollment, and data on HBV virus and serology, clinical biochemistry, liver and lung imaging, COVID-19 nucleic acid and COVID-19 antibody examination of patients were collected. After enrollment, prospective anti-HBV treatment, HBV virology, clinical biochemistry, liver imaging and COVID-19 infection and morbidity were observed. The patients with COVID-19 infection during the prospective observation period were observed for COVID-19 infection, onset and treatment, including body temperature, clinical symptoms, signs, cardiac examination, pulmonary imaging, COVID-19, clinical biochemistry, disease severity, time of virus negative conversion, hospital stay and outcome. The influence of COVID-19 infection on liver disease and the influence of interferon anti-HBV treatment on COVID-19 infection, its pathogenesis and prognosis were studied.
Detailed description
This is a two-way (retrospective+prospective) study of COVID-19 infection in an observational cohort of patients with chronic hepatitis B treated with antiviral therapy. Patients with chronic hepatitis B who received anti-HBV treatment in the Department of Hepatology Division 2, Beijing Ditan Hospital, Capital Medical University from February 2022 to December 2023 were enrolled. After enrollment, demographic data of patients, information on antiviral treatment of chronic hepatitis B, COVID-19 vaccination, COVID-19 infection and COVID-19 incidence and treatment from January 2022 to pre enrollment, and data on hepatitis B virus and serology, clinical biochemistry, liver and lung imaging, COVID-19 nucleic acid and COVID-19 antibody examination of patients were collected. After enrollment, prospective anti hepatitis B virus treatment, HBV virology, clinical biochemistry, liver imaging and COVID-19 infection and morbidity were observed. The patients with COVID-19 infection during the prospective observation period were observed for COVID-19 infection, onset and treatment, including body temperature, clinical symptoms, signs, cardiac examination, pulmonary imaging, COVID-19, clinical biochemistry, disease severity, time of virus negative conversion, hospital stay and outcome. The influence of COVID-19 infection on liver disease and the influence of interferon anti hepatitis B virus treatment on COVID-19 infection, its pathogenesis and prognosis were explored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interferon treatment group | – | Drug: InterferonPatients with chronic hepatitis B who received antiviral treatment with Interferon at the Second Department of Hepatology, Beijing Ditan Hospital Affiliated to Capital Medical University from February 2022 to December 2023 were enrolled. |
| nucleoside analogues treatment group | – | Drug: nucleoside analoguesPatients with chronic hepatitis B who received antiviral treatment with nucleoside analogues at the Second Department of Hepatology, Beijing Ditan Hospital Affiliated to Capital Medical University from February 2022 to December 2023 were enrolled |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- During 48 weeks of the prospective observation period, the treated patients continuously use the original treatment. After the initial treatment patients are enrolled, they receive antiviral treatment with interferon or nucleoside analogues according to the needs of the disease. During the treatment period, the corresponding virology, serology, clinical biochemistry and liver imaging examinations of hepatitis B antiviral treatment were carried out every 3-6 months. During COVID-19 infection, the patient shall be checked for clinical symptoms, clinical biochemistry, blood routine, pulmonary imaging, COVID-19 and antibodies, as well as other organs and functional indicators required by clinical needs.
Key inclusion criteria (3 listed)
- 1) HBsAg positive for 6 months.
- 2) Patients undergoing initial or ongoing antiviral treatment.
- 3) HBeAg status and HBV DNA level are not limited.
Key exclusion criteria (2 listed)
- 1) Patients with decompensated liver cirrhosis or previous decompensated liver cirrhosis.
- 2) At the same time, it is associated with other viral infections, such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, HIV, etc. - 3) Accompanied with other serious physical and mental diseases, including uncontrolled primary kidney, heart, lung, vascular, nervous, digestive, severe metabolic diseases (such as uncontrolled hyperthyroidism, diabetes, serious complications, adrenal diseases, etc.), immunodeficiency disease, and accompanied with serious infection; History of active or suspected malignant tumors or malignant tumors.
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: peg-interferon alphaThe naive treated patients with chronic hepatitis B were given antiviral treatment with interferon according to their condition. | Drug | Interferon treatment group |
| nucleoside analoguesAlso: NAsThe naive treated patients with chronic hepatitis B were given antiviral treatment with nucleoside analogues according to their condition. | Drug | nucleoside analogues treatment group |
Primary outcome
The rate of COVID-19 infection.
Time frame: 48 weeks after therapy
The rate of chronic hepatitis B patients infected with COVID-19 after initial antiviral treatment.
2 secondary outcomes
The rate of severe disease after COVID-19 infection.
Time frame: 48 weeks after therapy
The hospitalization rate and duration of COVID-19.
Time frame: 48 weeks after therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
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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, Doctor principal investigator
Beijing Ditan Hospital
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 and COVID-19 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 3 inclusion and 2 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 31 Mar 2023. 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 (8610-84322200, xieyao00120184@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of COVID-19 infection. (time frame: 48 weeks after therapy). 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 31 Mar 2023.