HBVPhase 4NCT06503796
Antiviral Therapy in Infants With HBV Infection
A Phase 4 study testing Lamivudine and Interferon in people with HBV, run by Beijing 302 Hospital at 1 site in China.
Trial summary
This study was a multicenter, prospective randomized controlled clinical study. A total of 60 HBV-infected infants with ALT ≤5 times the upper limit of normal (ULN) and without pathological jaundice were enrolled and randomized 1:1 into two groups: the control group and the antiviral treatment group. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- HBV
- What is being tested?
- Lamivudine and Interferon
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Aug 2024to Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- a. Age ≤ 1 year;
- b. HBsAg and HBV DNA positive;
- c. ALT ≤ 5 times the upper limit of normal (ULN) and no pathologic jaundice (two consecutive tests with an interval of 2 weeks - 3 months).
- d. Parents are willing to participate in the study and sign an informed consent form, for children without parents, all legal guardians of need to give informed consent.
Who cannot join
- a. Combined viral infections such as HAV, HCV, HDV, HEV, HIV, EBV, CMV, etc;
- b. Combination of other liver diseases, such as autoimmune hepatitis, drug-induced liver injury, Wilson's disease;
- c. WBC <9 × 10^9/L, or PLT <90 × 10^9/L;
- d. Combination of other systemic serious diseases or hereditary diseases, etc;
- e. Other conditions deemed by the investigator to be unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the Fifth Medical Center of PLA
Beijing
Junliang Fu, PhD, MD, 86-10-66933214
Fu-Sheng Wang, PhD, MD, 86-10-66933328, fswang302@163.com
About this study
This study was a multicenter, prospective randomized controlled clinical study. A total of 60 HBV-infected infants with ALT ≤5 times the upper limit of normal (ULN) and without pathological jaundice were enrolled and randomized 1:1 into two groups: the control group and the antiviral treatment group. HBV-infected infants in the treatment group were treated with LAM before the age of 1 year and then combined with regular interferon for 52 weeks if they were still positive for HBV DNA and/or HBsAg after reaching the age of 1 year. The control group was followed up synchronously. Follow-up was conducted every 3 months during the study period. The main efficacy evaluation indexes: HBsAg conversion (functional cure) rate, HBeAg conversion rate, HBeAg seroconversion rate, HBV DNA conversion rate, HBsAg seroconversion rate, and ALT reversion rate at the end of 12 months of treatment and at 2 years of age.
- Conditions
- HBV
- Being tested
- Lamivudine, Interferon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LamivudineDrug
4mg/kg/d, oral
InterferonDrug
Use only in children who remain positive for HBV-DNA and/or HBsAg after 1 year of age. Regular interferon (3 million U/m2 body surface area, intramuscular or subcutaneous, every other day, adjusted during treatment according to the child's specific tolerance) for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| the antiviral group | Experimental | HBV-infected infants in the treatment group were treated with LAM (4 mg/kg/d) before 1 year of age, and then combined with regular interferon (intramuscular or subcutaneous injection, 3-6 million U/m2 body surface area, every other day, with a starting dose of 3 million U/m2 body surface area, which was adjusted according to the specific tolerances of the children during the course of the treatment) if they were still HBV DNA and/or HBsAg-positive at the end of the 1st year of age. The course of interferon treatment is 52 weeks. Receives: Drug: Lamivudine; Drug: Interferon |
| the control group | No intervention | synchronized follow-up visits without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of HBsAg loss
The rate of HBsAg loss in 12months after intervention, 2 years old
Measured: 12months after intervention, 2 years old
Secondary outcomes (6)
The rate of HBsAg seroconversion
The rate of HBsAg seroconversion in 12months after intervention, 2 years old
Measured: 12months after intervention, 2 years old
The rate of HBV DNA loss
The rate of HBV DNA loss in 12months after intervention, 2 years old
Measured: 12months after intervention, 2 years old
The rate of HBeAg loss
The rate of HBeAg loss in 12months after intervention, 2 years old
Measured: 12months after intervention, 2 years old
The rate of HBeAg seroconversion
The rate of HBeAg seroconversion in 12months after intervention, 2 years old
Measured: 12months after intervention, 2 years old
ALT reversion rate
ALT reversion rate in 12months after intervention, 2 years old
Measured: 12months after intervention, 2 years old
Incidence of Treatment-Emergent Adverse Events
Safety and Tolerability of Antiviral Therapy in infants
Measured: 12months after intervention, 2 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBVStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- the antiviral group and the control group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junliang Fu, Principal investigator, The fifth medical center of PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503796
- Sponsor's protocol ID
- KY-2023-12-85-1
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 23 Jul 2024
- 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 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiviral Therapy in Infants With HBV Infection
- ClinicalTrials.gov ID
- NCT06503796
- Acronym / sponsor ID
- KY-2023-12-85-1
- Conditions
- HBV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 16 Jul 2024 (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.
This study was a multicenter, prospective randomized controlled clinical study. A total of 60 HBV-infected infants with ALT ≤5 times the upper limit of normal (ULN) and without pathological jaundice were enrolled and randomized 1:1 into two groups: the control group and the antiviral treatment group. HBV-infected infants in the treatment group were treated with LAM before the age of 1 year and then combined with regular interferon for 52 weeks if they were still positive for HBV DNA and/or HBsAg after reaching the age of 1 year. The control group was followed up synchronously. Follow-up was conducted every 3 months during the study period. The main efficacy evaluation indexes: HBsAg conversion (functional cure) rate, HBeAg conversion rate, HBeAg seroconversion rate, HBV DNA conversion rate, HBsAg seroconversion rate, and ALT reversion rate at the end of 12 months of treatment and at 2 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the antiviral group and the control group
| Arm | Type | Receives |
|---|---|---|
| the antiviral group | Experimental | Drug: Lamivudine, Drug: InterferonHBV-infected infants in the treatment group were treated with LAM (4 mg/kg/d) before 1 year of age, and then combined with regular interferon (intramuscular or subcutaneous injection, 3-6 million U/m2 body surface area, every other day, with a starting dose of 3 million U/m2 body surface area, which was adjusted according to the specific tolerances of the children during the course of the treatment) if they were still HBV DNA and/or HBsAg-positive at the end of the 1st year of age. The course of interferon treatment is 52 weeks. |
| the control group | No intervention | –synchronized follow-up visits without intervention |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- a. Age ≤ 1 year;
- b. HBsAg and HBV DNA positive;
- c. ALT ≤ 5 times the upper limit of normal (ULN) and no pathologic jaundice (two consecutive tests with an interval of 2 weeks - 3 months).
- d. Parents are willing to participate in the study and sign an informed consent form, for children without parents, all legal guardians of need to give informed consent.
Key exclusion criteria (5 listed)
- a. Combined viral infections such as HAV, HCV, HDV, HEV, HIV, EBV, CMV, etc;
- b. Combination of other liver diseases, such as autoimmune hepatitis, drug-induced liver injury, Wilson's disease;
- c. WBC <9 × 10^9/L, or PLT <90 × 10^9/L;
- d. Combination of other systemic serious diseases or hereditary diseases, etc;
- e. Other conditions deemed by the investigator to be unsuitable for participation in this study.
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 |
|---|---|---|
| Lamivudine4mg/kg/d, oral | Drug | the antiviral group |
| InterferonUse only in children who remain positive for HBV-DNA and/or HBsAg after 1 year of age. Regular interferon (3 million U/m2 body surface area, intramuscular or subcutaneous, every other day, adjusted during treatment according to the child's specific tolerance) for 52 weeks. | Drug | the antiviral group |
Primary outcome
The rate of HBsAg loss
Time frame: 12months after intervention, 2 years old
The rate of HBsAg loss in 12months after intervention, 2 years old
6 secondary outcomes
The rate of HBsAg seroconversion
Time frame: 12months after intervention, 2 years old
The rate of HBV DNA loss
Time frame: 12months after intervention, 2 years old
The rate of HBeAg loss
Time frame: 12months after intervention, 2 years old
The rate of HBeAg seroconversion
Time frame: 12months after intervention, 2 years old
ALT reversion rate
Time frame: 12months after intervention, 2 years old
Incidence of Treatment-Emergent Adverse Events
Time frame: 12months after intervention, 2 years old
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- 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.
Junliang Fu principal investigator
The fifth medical center of PLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lamivudine and Interferon in people with HBV, run by Beijing 302 Hospital 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 23 Jul 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junliang Fu, PhD, MD (86-10-66933214, fjunliang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of HBsAg loss (time frame: 12months after intervention, 2 years old). 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 23 Jul 2024.