HBeAg Positive Chronic Hepatitis BPhase 4NCT04565262
Study on Antiviral Therapy for HBeAg-positive Chronic Hepatitis B Patients Aged 1-16 Years
A Phase 4 study testing NAs+IFN-α in people with HBeAg Positive Chronic Hepatitis B, run by Beijing 302 Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- HBeAg Positive Chronic Hepatitis B
- What is being tested?
- NAs+IFN-α
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Sep 2020to Sep 2023
- Phase
- Phase 4
- 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 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Min Zhang
Beijing, Beijing Municipality
Min Zhang, 13911517721 ext. 010-63879847, gcmw2001@163.com
About this study
Official title: Multi-center Study of IFN Combined With Nucleosides Analog Antiviral Therapy in Pediatric Patients With HBeAg Positive Chronic Hepatitis B (CHB) Aged 1-16 Years
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
Read the detailed description
This research is a national multicenter, randomized, prospective study. The planned sample size is 200 subjects in 1-16 years pediatric patients with HBeAg positive Chronic Hepatitis B (CHB). 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. Regularly Blood cell count, biochemical test, hepatitis B viral markers test, and lymphocyte subsets test were exerted. To compare the curative effect of group A and group B, The primary monitoring indicator is HBsAg clearance rate, and the secondary monitoring indicator is hepatitis B virus (HBV) DNA clearance，HBeAg seroconversion in these patients,. So that we can make the optimal antiviral treatment strategy for 1-16-year-old children with CHB，and try to find out the possible influencing factors of function cure
- Conditions
- HBeAg Positive Chronic Hepatitis B
- Being tested
- NAs+IFN-α
- Keywords
- hepatitis B,chronic; Interferon ; Nucleosides;child
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAs+IFN-αDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| NAs+IFN-α | Experimental | NAs+IFN-α/ 96w Receives: Drug: NAs+IFN-α |
| NAs+(IFN-α+ NAs ) | Other | NAs/48w+(IFN-α+ NAs)/96w Receives: Drug: NAs+IFN-α |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 168 weeks
Secondary outcomes (3)
The rate of HBeAg clearance / seroconversion
The rate of HBeAg clearance / seroconversion in patients with CHB
Measured: 168 weeks
HBV DNA negative conversion rate
HBV DNA negative conversion rate in patients with CHB
Measured: 168 weeks
ALT(Alanine aminotransferase) recovery rate
ALT recovery rate in patients with CHB
Measured: 168 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study startSep 2020 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBeAg Positive Chronic Hepatitis BStudies 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
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Zhang, Dcotor, Principal investigator, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565262
- Sponsor's protocol ID
- R2020050DA010
- Status last verified
- Aug 2020
- First submitted
- 22 Jun 2020
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Study of IFN Combined With Nucleosides Analog Antiviral Therapy in Pediatric Patients With HBeAg Positive Chronic Hepatitis B (CHB) Aged 1-16 Years
- ClinicalTrials.gov ID
- NCT04565262
- Acronym / sponsor ID
- R2020050DA010
- Conditions
- HBeAg Positive Chronic Hepatitis B
- Keywords
- hepatitis B,chronic; Interferon ; Nucleosides;child
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 25 Sep 2020 (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.
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
Detailed description
This research is a national multicenter, randomized, prospective study. The planned sample size is 200 subjects in 1-16 years pediatric patients with HBeAg positive Chronic Hepatitis B (CHB). 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. Regularly Blood cell count, biochemical test, hepatitis B viral markers test, and lymphocyte subsets test were exerted. To compare the curative effect of group A and group B, The primary monitoring indicator is HBsAg clearance rate, and the secondary monitoring indicator is hepatitis B virus (HBV) DNA clearance，HBeAg seroconversion in these patients,. So that we can make the optimal antiviral treatment strategy for 1-16-year-old children with CHB，and try to find out the possible influencing factors of function cure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| NAs+IFN-α | Experimental | Drug: NAs+IFN-αNAs+IFN-α/ 96w |
| NAs+(IFN-α+ NAs ) | Other | Drug: NAs+IFN-αNAs/48w+(IFN-α+ NAs)/96w |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| NAs+IFN-αNAs+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. | Drug | NAs+(IFN-α+ NAs ), NAs+IFN-α |
Primary outcome
The rates of HBsAg serological disappearance / conversion in CHB patients at 48 weeks
Time frame: 48 weeks
The rates of HBsAg serological disappearance / conversion in CHB patients at 48 weeks
The rates of HBsAg serological disappearance / conversion in CHB patients at 96 weeks
Time frame: 96 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 144 weeks
Time frame: 144 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 168 weeks
Time frame: 168 weeks
The rates of HBsAg serological disappearance / conversion in CHB patients at 168 weeks
3 secondary outcomes
The rate of HBeAg clearance / seroconversion
Time frame: 168 weeks
HBV DNA negative conversion rate
Time frame: 168 weeks
ALT(Alanine aminotransferase) recovery rate
Time frame: 168 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
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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.
Min Zhang, Dcotor principal investigator
Beijing 302 Hospital
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 NAs+IFN-α in people with HBeAg Positive Chronic Hepatitis B, 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 7 inclusion and 8 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 30 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Zhang, Doctor (13911517721 ext. 010-63879847, gcmw2001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rates of HBsAg serological disappearance / conversion in CHB patients at 48 weeks (time frame: 48 weeks). The study lists 4 primary outcomes in all. 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 30 Sep 2020.