Chronic HBV InfectionNCT05792761
A Study on Antiviral Treatment of Chronic Hepatitis B in Children
A study testing Peginterferon alfa-2b combined and ETV in people with Chronic HBV Infection, run by Fang Wang at 1 site in China.
Trial summary
There are nearly 2 million HBsAg-positive children who are in urgent need of professional diagnosis and treatment in China. Chronic hepatitis B (CHB) is the leading cause of childhood liver disease. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Chronic HBV Infection
- What is being tested?
- Peginterferon alfa-2b combined and ETV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,900 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1.Inclusion criteria for treatment-naïve children with hepatitis B:
- Aged 3 to 18 (included 3 years old, but exclude 18 years old);
- HBV DNA positive (higher than the lower detection limit or >20 IU/ml. Roche reagent is recommended).
- HBsAg positive (higher than lower detection limit or >0.05 IU/ml. Roche reagent is recommended).
- 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.
- 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.
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- 2.Inclusion criteria for NA-treated children with hepatitis B:
- Aged 3 to 18 (included 3 years old, but exclude 18 years old);
- Previously received NA treatment for ≥ 1 year.
- HBsAg positive (higher than lower detection limit or >0.05 IU/ml. Roche reagent is recommended).
- 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:
- Aged 3 to 18 (included 3 years old, but exclude 18 years old);
- HBV DNA positive (higher than lower detection limit or >20 IU/ml. Roche reagent is recommended).
- HBsAg positive (higher than lower detection limit or >0.05 IU/ml. Roche reagent is recommended).
- Serum ALT and AST remain persistently normal (2 consecutive follow-up visits within half a year, with an interval of at least 3 months)
- 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.
Who cannot join
- Co-infected with HAV, HCV, HDV, HEV or HIV.
- Patients with contraindications to peginterferon alfa-2b, including but not limit to :
- Hepatitis B cirrhosis decompensated stage.
- Child patient with autoimmune liver disease, metabolic liver disease or alcoholic liver disease; malignant tumor, decompensated liver disease, or organ transplantation.
- Child patient with severe neurological or mental disorders.
- Child patient with severe hyperthyroidism or other autoimmune disorders.
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- Child patient with diabetes under poorly controlled.
- Child patient with retinal or fundus lesions.
- Child patient with severe heart disease, coronary heart disease or cerebrovascular disease.
- Child patient with poorly controlled epilepsy.
- Child patient with severe renal dysfunction, e.g. creatinine > 1.5 ULN.
- Child patient who in the opinion of the investigator is unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen Third People Hospital
Shenzhen
Fang Wang, +8613682662543, kaixin919@163.com
About this study
Official title: A Study on Antiviral Treatment of Chronic Hepatitis B in Children (Sprout Project)
There are nearly 2 million HBsAg-positive children who are in urgent need of professional diagnosis and treatment in China. Chronic hepatitis B (CHB) is the leading cause of childhood liver disease. After infected with HBV virus, some children will develop disease progression, and some even develop cirrhosis and/or liver cancer. In pediatric liver cancer cases, up to 34% ~ 95% are caused by HBV infection.
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.
- Conditions
- Chronic HBV Infection
- Being tested
- Peginterferon alfa-2b combined and ETV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa-2b combined and ETVDrug
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.
- NA monotherapy group : received entecavir (ETV) for 96 weeks.
- Combination therapy group: received peginterferon alfa-2b combined with ETV for 96 weeks.
- Pulse therapy group :received peginterferon alfa-2b pulse treatment combined with ETV for 144 weeks.
| Study group | Role | What they receive |
|---|---|---|
| treatment-naïve children with hepatitis B | Experimental | Not described Receives: Drug: Peginterferon alfa-2b combined and ETV |
| previously treated children with hepatitis B | Experimental | Not described Receives: Drug: Peginterferon alfa-2b combined and ETV |
| chronic HBV carrying children with normal ALT | Experimental | Not described Receives: Drug: Peginterferon alfa-2b combined and ETV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate.
Defined as the proportion of child patients with HBsAg < 0.05 IU / mL (or below the lower detection limit) 24 weeks after completing treatment, HBeAg negative, HBV DNA undetectable, and normalization of liver biochemical indexes (ALT and AST).
Measured: 24 weeks after completing treatment.
Secondary outcomes (11)
Proportion of patients with HBV-DNA negative in those with HBV-DNA positive at baseline.
Defined as HBV-DNA below the lower detection limit, or< 20 IU/mL.
Measured: 24 weeks after treatment completion
HBeAg seroconversion rate in HBeAg positive children.
Defined as HBeAg negative and anti-HBe positive.
Measured: 24 weeks after treatment completion.
HBsAg seroconversion rate.
Defined as HBsAg < 0.05 IU/mL and anti-HBe positive.
Measured: 24 weeks after treatment completion.
ALT normalization rate.
Measured: 48 weeks and 96 weeks after starting treatment
Decrease of HBV-DNA compared to baseline.
Measured: 24 weeks after treatment completion.
Decrease of HBeAg compared to baseline.
Measured: 24 weeks after treatment completion.
Decrease of HBsAg compared to baseline.
Measured: 24 weeks after treatment completion.
The incidence of adverse reactions.
Including fever, influenza-like symptoms, decreased hemogram, jaundice ALT> 400U/L, abnormal renal function, abnormal thyroid function, abnormal blood phosphorus and blood calcium during treatment (lower or higher than the normal value).
Measured: 24weeks ,48 weeks and 96 weeks after starting treatment
The effects on height
Measured: 24weeks ,48 weeks and 96 weeks after starting treatment
The effects on weight
Measured: 24weeks ,48 weeks and 96 weeks after starting treatment
The effects on bone age.
Measured: 24weeks ,48 weeks and 96 weeks after starting treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start6 May 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic HBV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fang Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fang Wang, Shenzhen Third People's Hospital
- Investigators
- Qing He, Principal investigator, Shenzhen Third People's HospitalHongfei Zhang, Principal investigator, Beijing Tsinghua Changgeng HospitalFang Wang, Study chair, Shenzhen Third People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792761
- Sponsor's protocol ID
- Sprout project
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Antiviral Treatment of Chronic Hepatitis B in Children (Sprout Project)
- ClinicalTrials.gov ID
- NCT05792761
- Acronym / sponsor ID
- Sprout project
- Conditions
- Chronic HBV Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,900 participants (estimated)
- Lead sponsor
- Fang WangUniversity, hospital or other
- Study start
- 6 May 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are nearly 2 million HBsAg-positive children who are in urgent need of professional diagnosis and treatment in China. Chronic hepatitis B (CHB) is the leading cause of childhood liver disease. After infected with HBV virus, some children will develop disease progression, and some even develop cirrhosis and/or liver cancer. In pediatric liver cancer cases, up to 34% ~ 95% are caused by HBV infection.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| treatment-naïve children with hepatitis B | Experimental | Drug: Peginterferon alfa-2b combined and ETV |
| previously treated children with hepatitis B | Experimental | Drug: Peginterferon alfa-2b combined and ETV |
| chronic HBV carrying children with normal ALT | Experimental | Drug: Peginterferon alfa-2b combined and ETV |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (17 listed)
- Aged 3 to 18 (included 3 years old, but exclude 18 years old);
- HBV DNA positive (higher than the lower detection limit or >20 IU/ml. Roche reagent is recommended).
- HBsAg positive (higher than lower detection limit or >0.05 IU/ml. Roche reagent is recommended).
- 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.
- 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.
Key exclusion criteria (12 listed)
- Co-infected with HAV, HCV, HDV, HEV or HIV.
- Patients with contraindications to peginterferon alfa-2b, including but not limit to :
- Child patient with severe renal dysfunction, e.g. creatinine > 1.5 ULN.
- Child patient who in the opinion of the investigator is unsuitable for enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peginterferon alfa-2b combined and ETVChild 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. | Drug | chronic HBV carrying children with normal ALT, previously treated children with hepatitis B, treatment-naïve children with hepatitis B |
Primary outcome
Clinical cure rate.
Time frame: 24 weeks after completing treatment.
Defined as the proportion of child patients with HBsAg < 0.05 IU / mL (or below the lower detection limit) 24 weeks after completing treatment, HBeAg negative, HBV DNA undetectable, and normalization of liver biochemical indexes (ALT and AST).
11 secondary outcomes
Proportion of patients with HBV-DNA negative in those with HBV-DNA positive at baseline.
Time frame: 24 weeks after treatment completion
HBeAg seroconversion rate in HBeAg positive children.
Time frame: 24 weeks after treatment completion.
HBsAg seroconversion rate.
Time frame: 24 weeks after treatment completion.
ALT normalization rate.
Time frame: 48 weeks and 96 weeks after starting treatment
Decrease of HBV-DNA compared to baseline.
Time frame: 24 weeks after treatment completion.
Decrease of HBeAg compared to baseline.
Time frame: 24 weeks after treatment completion.
Decrease of HBsAg compared to baseline.
Time frame: 24 weeks after treatment completion.
The incidence of adverse reactions.
Time frame: 24weeks ,48 weeks and 96 weeks after starting treatment
The effects on height
Time frame: 24weeks ,48 weeks and 96 weeks after starting treatment
The effects on weight
Time frame: 24weeks ,48 weeks and 96 weeks after starting treatment
The effects on bone age.
Time frame: 24weeks ,48 weeks and 96 weeks after starting treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qing He principal investigator
Shenzhen Third People's Hospital
Hongfei Zhang principal investigator
Beijing Tsinghua Changgeng Hospital
Fang Wang study chair
Shenzhen Third People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peginterferon alfa-2b combined and ETV in people with Chronic HBV Infection, run by Fang Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fang Wang (+8613682662543, kaixin919@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure rate. (time frame: 24 weeks after completing treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.