A Study on Antiviral Treatment of Chronic Hepatitis B in Children
NCT ID: NCT05792761
Last Updated: 2023-03-31
Study Results
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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RECRUITING
NA
1900 participants
INTERVENTIONAL
2021-05-06
2025-12-31
Brief Summary
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Although two major classes of drugs have been approved for the treatment of chronic hepatitis B in adults, and there are multiple guidelines worldwide for the management of HBV infection in adults, there is lack of guidelines specifically for the management of children with HBV infection. In addition, the treatment of chronic hepatitis B in children faced great difficulties due to the lack of evidence-based medical evidence for antiviral treatment of chronic hepatitis B in children and fewer drugs approved for anti-HBV treatment in children. The timing of treatment, medications, and clinical management strategies are all controversial.
This study ( Sprout project)，is a multicenter, prospective, cohort study in China, aiming to explore and optimize the antiviral treatment regimen for children with HBV infection, to provide evidence-based medical for antiviral treatment, and to provide basis evidence for the standardized management of children infection with HBV in China. The study is expected to enroll 1900 pediatric patients with HBV infection, and patient will received one of the three following treatment Strategies: nucleoside monotherapy, peginterferon α- combined with nucleoside therapy, or peginterferon α-pulse therapy combined with nucleoside therapy, according to their illness state and desire, and the safety and efficacy will be evaluated.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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treatment-naïve children with hepatitis B
Peginterferon alfa-2b combined and ETV
Child patients are assigned to one of the 3 treatment regimens according to their illness state and treatment desire of their parents/guardians, and the number of patients in each group is expected to limited to 300.
1. NA monotherapy group : received entecavir (ETV) for 96 weeks.
2. Combination therapy group: received peginterferon alfa-2b combined with ETV for 96 weeks.
3. Pulse therapy group :received peginterferon alfa-2b pulse treatment combined with ETV for 144 weeks.
previously treated children with hepatitis B
Peginterferon alfa-2b combined and ETV
Child patients are assigned to one of the 3 treatment regimens according to their illness state and treatment desire of their parents/guardians, and the number of patients in each group is expected to limited to 300.
1. NA monotherapy group : received entecavir (ETV) for 96 weeks.
2. Combination therapy group: received peginterferon alfa-2b combined with ETV for 96 weeks.
3. Pulse therapy group :received peginterferon alfa-2b pulse treatment combined with ETV for 144 weeks.
chronic HBV carrying children with normal ALT
Peginterferon alfa-2b combined and ETV
Child patients are assigned to one of the 3 treatment regimens according to their illness state and treatment desire of their parents/guardians, and the number of patients in each group is expected to limited to 300.
1. NA monotherapy group : received entecavir (ETV) for 96 weeks.
2. Combination therapy group: received peginterferon alfa-2b combined with ETV for 96 weeks.
3. Pulse therapy group :received peginterferon alfa-2b pulse treatment combined with ETV for 144 weeks.
Interventions
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Peginterferon alfa-2b combined and ETV
Child patients are assigned to one of the 3 treatment regimens according to their illness state and treatment desire of their parents/guardians, and the number of patients in each group is expected to limited to 300.
1. NA monotherapy group : received entecavir (ETV) for 96 weeks.
2. Combination therapy group: received peginterferon alfa-2b combined with ETV for 96 weeks.
3. Pulse therapy group :received peginterferon alfa-2b pulse treatment combined with ETV for 144 weeks.
Eligibility Criteria
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Inclusion Criteria
2. HBV DNA positive (higher than the lower detection limit or \>20 IU/ml. Roche reagent is recommended).
3. HBsAg positive (higher than lower detection limit or \>0.05 IU/ml. Roche reagent is recommended).
4. ALT flares between 1 to10 ULN at least twice a year. If the last examination result is higher than 5ULN, the investigator shall comprehensively judge whether the child patient is suitable to participate in this study.
5. The guardian should understand and sign the informed consent form (if parents is the legal guardians, they both must sign the informed consent form). Children older than 8 years (included) also must sign the informed consent form. The consent comment of child patient under the age of 8 should also be clearly recorded.
1. Aged 3 to 18 (included 3 years old, but exclude 18 years old);
2. Previously received NA treatment for ≥ 1 year.
3. HBsAg positive (higher than lower detection limit or \>0.05 IU/ml. Roche reagent is recommended).
4. The guardian should understand and sign the informed consent form (if parents is the legal guardians, they both must sign the informed consent form). Children older than 8 years (included) also must sign the informed consent form. The consent comment of child patient under the age of 8 should also be clearly recorded.
1. Aged 3 to 18 (included 3 years old, but exclude 18 years old);
2. HBV DNA positive (higher than lower detection limit or \>20 IU/ml. Roche reagent is recommended).
3. HBsAg positive (higher than lower detection limit or \>0.05 IU/ml. Roche reagent is recommended).
4. Serum ALT and AST remain persistently normal (2 consecutive follow-up visits within half a year, with an interval of at least 3 months)
5. TThe guardian should understand and sign the informed consent form (if parents is the legal guardians, they both must sign the informed consent form). Children older than 8 years (included) also must sign the informed consent form. The consent comment of child patient under the age of 8 should also be clearly recorded.
Exclusion Criteria
2. Patients with contraindications to peginterferon alfa-2b, including but not limit to :
1. Hepatitis B cirrhosis decompensated stage.
2. Child patient with autoimmune liver disease, metabolic liver disease or alcoholic liver disease; malignant tumor, decompensated liver disease, or organ transplantation.
3. Child patient with severe neurological or mental disorders.
4. Child patient with severe hyperthyroidism or other autoimmune disorders.
5. Child patient with diabetes under poorly controlled.
6. Child patient with retinal or fundus lesions.
7. Child patient with severe heart disease, coronary heart disease or cerebrovascular disease.
8. Child patient with poorly controlled epilepsy.
3. Child patient with severe renal dysfunction, e.g. creatinine \> 1.5 ULN.
4. Child patient who in the opinion of the investigator is unsuitable for enrollment.
3 Years
18 Years
ALL
No
Sponsors
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Fang Wang
OTHER
Responsible Party
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Fang Wang
Chief physician
Principal Investigators
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Qing He
Role: PRINCIPAL_INVESTIGATOR
Shenzhen Third People's Hospital
Hongfei Zhang
Role: PRINCIPAL_INVESTIGATOR
Beijing Tsinghua Changgeng Hospital
Fang Wang
Role: STUDY_CHAIR
Shenzhen Third People's Hospital
Locations
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Shenzhen Third People Hospital
Shenzhen, , China
Countries
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Central Contacts
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Facility Contacts
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Fang Wang
Role: primary
Other Identifiers
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Sprout project
Identifier Type: -
Identifier Source: org_study_id