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

NCT04565262 | Unknown Phase 4 DMC

• 1 other identifier: R2020050DA010
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

HBeAg Positive Chronic Hepatitis B

Keywords

hepatitis B,chronic; Interferon ; Nucleosides;child

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  168 weeks

Secondary Outcomes (3)

• The rate of HBeAg clearance / seroconversion

  168 weeks

• HBV DNA negative conversion rate

  168 weeks

• ALT(Alanine aminotransferase) recovery rate

  168 weeks

Other Outcomes (5)

• Number of participants with treatment-related side effect and safety events as assessed by GSI

  168 weeks

• Average duration of HBeAg seroconversion

  168 weeks

• Average duration of disappearance of HBsAg

  168 weeks

Study Arms (2)

NAs+IFN-α

EXPERIMENTAL

NAs+IFN-α/ 96w

Drug: NAs+IFN-α

NAs+(IFN-α+ NAs )

OTHER

NAs/48w+(IFN-α+ NAs)/96w

Drug: NAs+IFN-α

Interventions

NAs+IFN-α 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+IFN-α

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing 302 Hospital: lead

Study Sites (1)

Min Zhang

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

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

Study Officials

• Min Zhang, Dcotor

  Beijing 302 Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Zhang, Doctor

CONTACT

13911517721; gcmw2001@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: September 25, 2020
• Study Start: September 1, 2020
• Primary Completion: July 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 30, 2020

Record last verified: 2020-08

Locations

CN (1)