- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04030039
Cohort Study of Clinical Outcomes in Chronic HBV Infection Patients With Low HBsAg Under Unplanned Intervention
July 20, 2019 updated by: Yao Xie, Beijing Ditan Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
420
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yao Xie, Doctor
- Phone Number: 010-84322284
- Email: xieyao00120184@sina.com
Study Contact Backup
- Name: Ming Hui Li, MD
- Phone Number: +(86)-13693259096
- Email: wuhm2000@sina.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100015
- Recruiting
- liver disease center, Beijing Ditan Hospital
-
Contact:
- Yao Xie, phD/MD
- Phone Number: 2489 8610-84322200
- Email: xieyao@public.nta.net.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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).
Description
Inclusion Criteria:
- Inactive carrier status and chronic hepatitis B (CHB) patients with anti-viral therapy (interferon and nucleoside analogues) reaching HBsAg < 100 IU/ml.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
chronic hepatitis B patients with interferon therapy
|
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
|
chronic hepatitis B patients with interferon therapy
|
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
|
chronic hepatitis B patients with interferon therapy
chronic hepatitis B patients with interferon therapy
|
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
|
chronic hepatitis B patients with interferon therapy
chronic hepatitis B patients with interferon therapy
|
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
|
chronic hepatitis B patients with interferon therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
96 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HBV DNA re-yang rate during the 96-week study period in different observation cohorts
Time Frame: 96 weeks
|
HBV DNA re-yang rate and HBeAg re-yang rate during the 96-week study period in different observation cohorts
|
96 weeks
|
HBeAg re-yang rate during the 96-week study
Time Frame: 96 weeks
|
HBeAg re-yang rate during the 96-week study
|
96 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
liver cancer during the 96-week study period in different observation cohorts Incidence
Time Frame: 96 weeks
|
liver cancer during the 96-week study period in different observation cohorts Incidence
|
96 weeks
|
Hepatitis episodes during the 96-week study period in different observation cohorts Incidence
Time Frame: 96 weeks
|
Hepatitis episodes during the 96-week study period in different observation cohorts Incidence
|
96 weeks
|
cirrhosis decompensation during the 96-week study period in different observation cohorts Incidence
Time Frame: 96 weeks
|
cirrhosis decompensation during the 96-week study period in different observation cohorts Incidence
|
96 weeks
|
its complications during the 96-week study period in different observation cohorts Incidence
Time Frame: 96 weeks
|
its complications during the 96-week study period in different observation cohorts Incidence
|
96 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yao Xie, Beijing Ditan Hospital, Beijing, China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2017
Primary Completion (Anticipated)
December 30, 2020
Study Completion (Anticipated)
December 30, 2020
Study Registration Dates
First Submitted
June 22, 2019
First Submitted That Met QC Criteria
July 20, 2019
First Posted (Actual)
July 23, 2019
Study Record Updates
Last Update Posted (Actual)
July 23, 2019
Last Update Submitted That Met QC Criteria
July 20, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Virus Diseases
- Blood-Borne Infections
- Disease Attributes
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Infections
- Communicable Diseases
- Hepatitis B
- Hepatitis
- Hepatitis B, Chronic
- Hepatitis, Chronic
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Interferons
Other Study ID Numbers
- DTXY017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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