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出境医 / 临床实验 / Cohort Study of Clinical Outcomes in Chronic HBV Infection Patients With Low HBsAg Under Unplanned Intervention
Cohort Study of Clinical Outcomes in Chronic HBV Infection Patients With Low HBsAg Under Unplanned Intervention
Study Description
Brief 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. 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.
| Condition or disease | Intervention/treatment |
|---|---|
| Chronic Hepatitis B Infection | Drug: Interferon Drug: nucleoside analogues |
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
| Study Type : | Observational |
| Estimated Enrollment : | 420 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Cohort Study of Clinical Outcomes in Chronic HBV Infection Patients With Low HBsAg Loads Under Unplanned Intervention |
| Actual Study Start Date : | May 1, 2017 |
| Estimated Primary Completion Date : | December 30, 2020 |
| Estimated Study Completion Date : | December 30, 2020 |
Arms 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
|
Drug: 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
|
Drug: 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
|
Drug: Interferon
chronic hepatitis B patients with interferon therapy
Drug: nucleoside analogues 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
|
Drug: Interferon
chronic hepatitis B patients with interferon therapy
Drug: nucleoside analogues 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
|
Drug: nucleoside analogues
chronic hepatitis B patients with interferon therapy
|
Outcome Measures
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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
- HBeAg re-yang rate during the 96-week study [ Time Frame: 96 weeks ]HBeAg re-yang rate during the 96-week study
Other Outcome Measures:
- 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
- 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
- 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
- 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
Eligibility Criteria
| Ages Eligible for Study: | 20 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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).
Criteria
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.
Contacts and Locations
Contacts
| Contact: Yao Xie, Doctor | 010-84322284 | xieyao00120184@sina.com | |
| Contact: Ming Hui Li, MD | +(86)-13693259096 | wuhm2000@sina.com |
Locations
| China, Beijing | |
| liver disease center, Beijing Ditan Hospital | Recruiting |
| Beijing, Beijing, China, 100015 | |
| Contact: Yao Xie, phD/MD 8610-84322200 ext 2489 xieyao@public.nta.net.cn | |
Sponsors and Collaborators
Beijing Ditan Hospital
Investigators
| Principal Investigator: | Yao Xie | Beijing Ditan Hospital, Beijing, China |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 22, 2019 | ||||||||
| First Posted Date | July 23, 2019 | ||||||||
| Last Update Posted Date | July 23, 2019 | ||||||||
| Actual Study Start Date | May 1, 2017 | ||||||||
| Estimated Primary Completion Date | December 30, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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
|
||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures |
|
||||||||
| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures |
|
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| Original Other Pre-specified Outcome Measures | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Cohort Study of Clinical Outcomes in Chronic HBV Infection Patients With Low HBsAg Under Unplanned Intervention | ||||||||
| Official Title | Cohort Study of Clinical Outcomes in Chronic HBV Infection Patients With Low HBsAg Loads Under Unplanned Intervention | ||||||||
| Brief 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. 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 Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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). | ||||||||
| Condition | Chronic Hepatitis B Infection | ||||||||
| Intervention |
|
||||||||
| Study Groups/Cohorts |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
420 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 30, 2020 | ||||||||
| Estimated Primary Completion Date | December 30, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender |
|
||||||||
| Ages | 20 Years to 70 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
|
||||||||
| Listed Location Countries | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04030039 | ||||||||
| Other Study ID Numbers | DTXY017 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Yao Xie, Beijing Ditan Hospital | ||||||||
| Study Sponsor | Beijing Ditan Hospital | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
|
||||||||
| PRS Account | Beijing Ditan Hospital | ||||||||
| Verification Date | July 2019 | ||||||||
