- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05792878
Study of COVID-19 Infection and Its Clinical Prognosis in Chronic Hepatitis B Patients With Antiviral Therapy
The Observational Study of COVID-19 Infection and Its Clinical Prognosis in Chronic Hepatitis B Patients With Antiviral Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Yao Xie, Doctor
- Phone Number: 8610-84322200
- Email: xieyao00120184@sina.com
Study Locations
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-
Beijing
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Beijing, Beijing, China, 100015
- Recruiting
- Department of Hepatology Division 2, Beijing Ditan Hospital
-
Contact:
- Yao Xie, Doctor
- Phone Number: 2489 8610-84322200
- Email: xieyao00120184@sina.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
- 1) HBsAg positive for 6 months.
- 2) Patients undergoing initial or ongoing antiviral treatment.
- 3) HBeAg status and HBV DNA level are not limited.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
The naive treated patients with chronic hepatitis B were given antiviral treatment with interferon according to their condition.
Other Names:
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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
|
The naive treated patients with chronic hepatitis B were given antiviral treatment with nucleoside analogues according to their condition.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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48 weeks after therapy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The rate of severe disease after COVID-19 infection.
Time Frame: 48 weeks after therapy
|
The rate of severe disease after COVID-19 infection for chronic hepatitis B patients after initial antiviral treatment.
|
48 weeks after therapy
|
The hospitalization rate and duration of COVID-19.
Time Frame: 48 weeks after therapy
|
The hospitalization rate and duration of COVID-19 for chronic hepatitis B patients after initial antiviral treatment.
|
48 weeks after therapy
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Blood-Borne Infections
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease Attributes
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- COVID-19
- Infections
- Communicable Diseases
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Hepatitis, Chronic
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Interferons
- Interferon-alpha
Other Study ID Numbers
- DTXY26
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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