Cohort Study of Clinical Outcomes in Chronic HBV Infection Patients With Low HBsAg Under Unplanned Intervention

NCT04030039 | Unknown

• 1 other identifier: DTXY017
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis B Infection

Keywords

Chronic hepatitis B; interferon; nucleotide; HBV; HBsAg; HBV DNA

Outcome Measures

Primary Outcomes (1)

• The incidence of HBsAg disappearance during the 96-week study in different observation cohorts

  The incidence of HBsAg disappearance during the 96-week study in different observation cohorts

  96 weeks

Secondary Outcomes (2)

• HBV DNA re-yang rate during the 96-week study period in different observation cohorts

  96 weeks

• HBeAg re-yang rate during the 96-week study

  96 weeks

Other Outcomes (4)

• 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

  96 weeks

• cirrhosis decompensation during the 96-week study period in different observation cohorts Incidence

  96 weeks

Study Arms (6)

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

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

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; Drug: nucleoside analogues

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; Drug: nucleoside analogues

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

Interventions

Interferon DRUG

chronic hepatitis B patients with interferon therapy

Therapy group A; Therapy group B; Therapy group C; Therapy group D

nucleoside analogues DRUG

chronic hepatitis B patients with interferon therapy

Therapy group C; Therapy group D; Therapy group E

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Inactive carrier status and chronic hepatitis B (CHB) patients with anti-viral therapy (interferon and nucleoside analogues) reaching HBsAg \< 100 IU/ml.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Ditan Hospital: lead

Study Sites (1)

liver disease center, Beijing Ditan Hospital

Beijing, Beijing Municipality, 100015, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Interferons

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Yao Xie

  Beijing Ditan Hospital, Beijing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yao Xie, Doctor

CONTACT

010-84322284; xieyao00120184@sina.com

Ming Hui Li, MD

CONTACT

+(86)-13693259096; wuhm2000@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of liver diseases center

Study Record Dates

• First Submitted: June 22, 2019
• First Posted: July 23, 2019
• Study Start: May 1, 2017
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

CN (1)