Antiviral treatment for children with chronic hepatitis B

A Study on Antiviral Treatment of Chronic Hepatitis B in Children (Sprout Project)

This study is testing a new combination of antiviral treatments for children with chronic hepatitis B to see if it can help them avoid serious liver problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1900 (estimated)
• Ages: 3 Years to 18 Years
• Sex: All
• Sponsor: Shenzhen Third People's Hospital (Academic / other)
• Locations: 1 site (Shenzhen)
• Trial ID: NCT05792761 on ClinicalTrials.gov

What this trial studies

This study focuses on the antiviral treatment of chronic hepatitis B (CHB) in children aged 3 to 18 years. It aims to address the urgent need for effective treatment options for nearly 2 million HBsAg-positive children in China, who are at risk of severe liver disease due to HBV infection. The study will evaluate the efficacy of a combination treatment using Peginterferon alfa-2b and Entecavir (ETV) in treatment-naïve and NA-treated children. The goal is to establish evidence-based guidelines for managing chronic hepatitis B in pediatric patients.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 3 to 18 years who are HBsAg positive and have elevated HBV DNA levels.

Not a fit: Patients who are older than 18 years or those without chronic hepatitis B infection will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective antiviral treatment options for children with chronic hepatitis B, potentially reducing the risk of liver disease progression.

How similar studies have performed: While there are established treatments for adults with chronic hepatitis B, this approach is novel for children, as there is a lack of evidence-based guidelines specifically for this population.

Eligibility criteria

Inclusion Criteria:

1.Inclusion criteria for treatment-naïve children with hepatitis B:

1. Aged 3 to 18 (included 3 years old, but exclude 18 years old);
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.

2.Inclusion criteria for NA-treated children with hepatitis B:

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.

3.Inclusion criteria for chronic HBV carrying children with normal ALT:

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:

1. Co-infected with HAV, HCV, HDV, HEV or HIV.
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.

Where this trial is running

Shenzhen

• Shenzhen Third People Hospital — Shenzhen, China (Recruiting)

Study contacts

• Principal investigator: Qing He — Shenzhen Third People's Hospital
• Study coordinator: Fang Wang

Conditions Chronic HBV Infection