Back to resultsStudy on Antiviral Therapy for HBeAg-positive Chronic Hepatitis B Patients Aged 1-16 Years
Primary Purpose
HBeAg Positive Chronic Hepatitis B
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
NAs+IFN-α
Sponsored by
About this trial
This is an interventional treatment trial for HBeAg Positive Chronic Hepatitis B focused on measuring hepatitis B,chronic; Interferon ; Nucleosides;child
Eligibility Criteria
Inclusion Criteria:
- Aged 1 to 16 years old.
- Chronic Hepatitis B (CHB) patients or HBsAg positive > 6 months patients who are line with the diagnostic criteria for chronic hepatitis B infection.
- ALT:40～400 U/L.
- HBeAg positive.
- HBV DNA>2×104IU/L.
- Liver histology: G<3.
- 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:
- 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.
- Combined with HAV、HCV、HDV、HEV or HIV-infected persons.
- 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.
- Patients with decompensated cirrhosis，including ascites.
- Received the following medications（Immunosuppressant and Systemic cytotoxic drugs）in six months.
- Patients who are allergy to IFNs and NAs;
- 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.
- Patients who unable to comply with the study arrangement judged by researcher.
Sites / Locations
- Min Zhang
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
NAs+IFN-α
NAs+(IFN-α+ NAs )
Arm Description
NAs+IFN-α/ 96w
NAs/48w+(IFN-α+ NAs)/96w
Outcomes
Primary Outcome Measures
The rates of HBsAg serological disappearance / conversion in CHB patients at 48 weeks
The rates of HBsAg serological disappearance / conversion in CHB patients at 48 weeks
The rates of HBsAg serological disappearance / conversion in CHB patients at 96 weeks
The rates of HBsAg serological disappearance / conversion in CHB patients at 96 weeks
The rates of HBsAg serological disappearance / conversion in CHB patients at 144 weeks
The rates of HBsAg serological disappearance / conversion in CHB patients at 144 weeks
The rates of HBsAg serological disappearance / conversion in CHB patients at 168 weeks
The rates of HBsAg serological disappearance / conversion in CHB patients at 168 weeks
Secondary Outcome Measures
The rate of HBeAg clearance / seroconversion
The rate of HBeAg clearance / seroconversion in patients with CHB
HBV DNA negative conversion rate
HBV DNA negative conversion rate in patients with CHB
ALT(Alanine aminotransferase) recovery rate
ALT recovery rate in patients with CHB
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04565262
Brief Title
Study on Antiviral Therapy for HBeAg-positive Chronic Hepatitis B Patients Aged 1-16 Years
Official Title
Multi-center Study of IFN Combined With Nucleosides Analog Antiviral Therapy in Pediatric Patients With HBeAg Positive Chronic Hepatitis B (CHB) Aged 1-16 Years
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing 302 Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HBeAg Positive Chronic Hepatitis B
Keywords
hepatitis B,chronic; Interferon ; Nucleosides;child
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NAs+IFN-α
Arm Type
Experimental
Arm Description
NAs+IFN-α/ 96w
Arm Title
NAs+(IFN-α+ NAs )
Arm Type
Other
Arm Description
NAs/48w+(IFN-α+ NAs)/96w
Intervention Type
Drug
Intervention Name(s)
NAs+IFN-α
Intervention Description
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.
Primary Outcome Measure Information:
Title
The rates of HBsAg serological disappearance / conversion in CHB patients at 48 weeks
Description
The rates of HBsAg serological disappearance / conversion in CHB patients at 48 weeks
Time Frame
48 weeks
Title
The rates of HBsAg serological disappearance / conversion in CHB patients at 96 weeks
Description
The rates of HBsAg serological disappearance / conversion in CHB patients at 96 weeks
Time Frame
96 weeks
Title
The rates of HBsAg serological disappearance / conversion in CHB patients at 144 weeks
Description
The rates of HBsAg serological disappearance / conversion in CHB patients at 144 weeks
Time Frame
144 weeks
Title
The rates of HBsAg serological disappearance / conversion in CHB patients at 168 weeks
Description
The rates of HBsAg serological disappearance / conversion in CHB patients at 168 weeks
Time Frame
168 weeks
Secondary Outcome Measure Information:
Title
The rate of HBeAg clearance / seroconversion
Description
The rate of HBeAg clearance / seroconversion in patients with CHB
Time Frame
168 weeks
Title
HBV DNA negative conversion rate
Description
HBV DNA negative conversion rate in patients with CHB
Time Frame
168 weeks
Title
ALT(Alanine aminotransferase) recovery rate
Description
ALT recovery rate in patients with CHB
Time Frame
168 weeks
Other Pre-specified Outcome Measures:
Title
Number of participants with treatment-related side effect and safety events as assessed by GSI
Description
Side effect and safety events include adverse events, adverse drug reactions etc. during the treatment
Time Frame
168 weeks
Title
Average duration of HBeAg seroconversion
Description
Average duration of HBeAg seroconversion during treatment
Time Frame
168 weeks
Title
Average duration of disappearance of HBsAg
Description
Average duration of disappearance of HBsAg during treatment
Time Frame
168 weeks
Title
Assessed the changes of liver stiffness measure by FibroScan after antiviral therapy
Description
Comparison the changes of liver stiffness before and after antiviral treatment (evaluated by FibroScan)
Time Frame
168 weeks
Title
Rate of relapse in patients after stop of antiviral therapy of NAs
Description
Rate of relapse in patients after stop of antiviral therapy of NAs
Time Frame
168 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 1 to 16 years old.
Chronic Hepatitis B (CHB) patients or HBsAg positive > 6 months patients who are line with the diagnostic criteria for chronic hepatitis B infection.
ALT:40～400 U/L.
HBeAg positive.
HBV DNA>2×104IU/L.
Liver histology: G<3.
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:
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.
Combined with HAV、HCV、HDV、HEV or HIV-infected persons.
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.
Patients with decompensated cirrhosis，including ascites.
Received the following medications（Immunosuppressant and Systemic cytotoxic drugs）in six months.
Patients who are allergy to IFNs and NAs;
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.
Patients who unable to comply with the study arrangement judged by researcher.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Zhang, Doctor
Phone
13911517721
Ext
010-63879847
Email
gcmw2001@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Zhang, Dcotor
Organizational Affiliation
Beijing 302 Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Min Zhang
City
Beijing
State/Province
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Zhang
Phone
13911517721
Ext
010-63879847
Email
gcmw2001@163.com
12. IPD Sharing Statement
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Study on Antiviral Therapy for HBeAg-positive Chronic Hepatitis B Patients Aged 1-16 Years
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