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Study on Antiviral Therapy for HBeAg-positive Chronic Hepatitis B Patients Aged 1-16 Years

NCT ID: NCT04565262

Last Updated: 2020-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2023-09-30

Brief Summary

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The purpose of this study is to provide theoretical and real world evidence for the optimization of antiviral treatment by IFN combined with Nucleosides analog in HBeAg positive chronic hepatitis B patients aged 1-16 years，so that the functional cure could be achieved in the greatest extent in pediatric patients

Detailed Description

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This research is a national multicenter, randomized, prospective study. The planned sample size is 200 subjects in 1-16 years pediatric patients with HBeAg positive Chronic Hepatitis B (CHB). These subjects will be randomized (1:1) to group A(treated with NAs + IFN for 96 weeks) and group B(treated with NAs for 48 weeks, then NAs combined with IFN for 96 weeks).Meanwhile, 1-6 years and 7-16 years patients should be distributed by 1:1 ratio by random method in both groups. Regularly Blood cell count, biochemical test, hepatitis B viral markers test, and lymphocyte subsets test were exerted. To compare the curative effect of group A and group B, The primary monitoring indicator is HBsAg clearance rate, and the secondary monitoring indicator is hepatitis B virus (HBV) DNA clearance，HBeAg seroconversion in these patients,. So that we can make the optimal antiviral treatment strategy for 1-16-year-old children with CHB，and try to find out the possible influencing factors of function cure

Conditions

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HBeAg Positive Chronic Hepatitis B

Keywords

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hepatitis B,chronic; Interferon ; Nucleosides;child

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

These subjects will be randomized (1:1) to group A(treated with NAs + IFN for 96 weeks) and group B(treated with NAs for 48 weeks, then NAs combined with IFN for 96 weeks).Meanwhile, 1-6 years and 7-16 years patients should be distributed by 1:1 ratio by random method in both groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NAs+IFN-α

NAs+IFN-α/ 96w

Group Type EXPERIMENTAL

NAs+IFN-α

Intervention Type DRUG

NAs+IFN-α:(NAs +IFN)/96 weeks：NAs（when the CHB patients\<2years old, the drug is LAM）combined with IFN-α（when the CHB patients\<3years old, the drug is IFN-α）for 96 weeks。 NAs+(NAs+IFN-α) :NAs/48weeks+(NAs+ IFN)/96 weeks：NAs（when the CHB patients\<2years old, the drug is LAM）for 48 weeks ，then combined with IFN-α（when the CHB patients\<3years old, the drug is IFN-α）for 96weeks。 Response guided treatment（RGT） by HBsAg quantification： The course of interferon alpha was 24 weeks after HBsAg and HBeAg turned negative up to 96 weeks, and NAs was discontinued 12 months after HBsAg serological conversion.

NAs+(IFN-α+ NAs )

NAs/48w+(IFN-α+ NAs)/96w

Group Type OTHER

NAs+IFN-α

Intervention Type DRUG

NAs+IFN-α:(NAs +IFN)/96 weeks：NAs（when the CHB patients\<2years old, the drug is LAM）combined with IFN-α（when the CHB patients\<3years old, the drug is IFN-α）for 96 weeks。 NAs+(NAs+IFN-α) :NAs/48weeks+(NAs+ IFN)/96 weeks：NAs（when the CHB patients\<2years old, the drug is LAM）for 48 weeks ，then combined with IFN-α（when the CHB patients\<3years old, the drug is IFN-α）for 96weeks。 Response guided treatment（RGT） by HBsAg quantification： The course of interferon alpha was 24 weeks after HBsAg and HBeAg turned negative up to 96 weeks, and NAs was discontinued 12 months after HBsAg serological conversion.

Interventions

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NAs+IFN-α

NAs+IFN-α:(NAs +IFN)/96 weeks：NAs（when the CHB patients\<2years old, the drug is LAM）combined with IFN-α（when the CHB patients\<3years old, the drug is IFN-α）for 96 weeks。 NAs+(NAs+IFN-α) :NAs/48weeks+(NAs+ IFN)/96 weeks：NAs（when the CHB patients\<2years old, the drug is LAM）for 48 weeks ，then combined with IFN-α（when the CHB patients\<3years old, the drug is IFN-α）for 96weeks。 Response guided treatment（RGT） by HBsAg quantification： The course of interferon alpha was 24 weeks after HBsAg and HBeAg turned negative up to 96 weeks, and NAs was discontinued 12 months after HBsAg serological conversion.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Aged 1 to 16 years old.
2. Chronic Hepatitis B (CHB) patients or HBsAg positive \> 6 months patients who are line with the diagnostic criteria for chronic hepatitis B infection.
3. ALT:40～400 U/L.
4. HBeAg positive.
5. HBV DNA\>2×104IU/L.
6. Liver histology: G\<3.
7. Agree to sign the Informed Consent Form (Children aged 1-6 years may be signed by the guardian; children between the ages of 7 and 11 are in principle signed by the child and the guardian; those over the age of 12 must be signed by the child and the guardian)

Exclusion Criteria

1. white blood cell (WBC)\< 3.5×109/L，PLT\< 80×1012/L，Pt A\<60%，total bilirubin (TBIL)\>34umol/L，ALB\<35g/L，Cr\>133umol/L.
2. Combined with HAV、HCV、HDV、HEV or HIV-infected persons.
3. Patients combined with other causes of liver disease：alcoholic or non-alcoholic liver disease，thyroid disease，autoimmune liver disease，genetic metabolic liver disease，bile duct diseases，or Parasitic infection of hepatobiliary tract.
4. Patients with decompensated cirrhosis，including ascites.
5. Received the following medications（Immunosuppressant and Systemic cytotoxic drugs）in six months.
6. Patients who are allergy to IFNs and NAs;
7. Patients with other severe or active psychosomatic diseases （kidney, heart, lungs, vascular, neurological, digestive including history of pancreatitis, metabolic diseases including diabetes, thyroid and Adrenal disease, adrenal disease or tumor), Researchers believe which affect the treatment, evaluation or compliance of patients with the study plan.
8. Patients who unable to comply with the study arrangement judged by researcher.
Minimum Eligible Age

1 Year

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing 302 Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min Zhang, Dcotor

Role: PRINCIPAL_INVESTIGATOR

Beijing 302 Hospital

Locations

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Min Zhang

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Min Zhang, Doctor

Role: CONTACT

Phone: 13911517721

Email: [email protected]

Facility Contacts

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Min Zhang

Role: primary

Other Identifiers

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R2020050DA010

Identifier Type: -

Identifier Source: org_study_id