Chronic Hepatitis bNCT06323681
Pegylated Interferon α in Previously Interferon-treated CHB（Leading Study）
A study testing Peginterferon α-2b based treatment group and NAs monotherapy group in people with Chronic Hepatitis b, run by Qing XIe at 1 site in China.
Trial summary
Previous clinical practice and exploratory studies suggest that some patients who have not achieved functional cure in the first round of interferon therapy can achieve HBsAg clearance by interferon retreatment (intermittent therapy), which can reduce the occurrence of complications such as liver fibrosis, liver… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- Peginterferon α-2b based treatment group and NAs monotherapy group
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,016 participants
- Where
- 1 siteChina
- Study dates
- 4 Feb 2024to Aug 2027
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand and sign the informed consent, participate in the study voluntarily.
- Aged between 18 and 65 (including 18 and 65).
- HBsAg positive for at least 6 months or other evidence suggests chronic hepatitis B.
- Had previously received interferon therapy, and discontinuation for at least 6 months at the time of enrollment, with a HBsAg level declined for at least 80% at the end of interferon treatment compared to the level of treatment started.
- HBsAg≤500 IU/mL at screening, and HBsAg rebound should not exceed 50% when compared to the HBsAg level of previously interferon treatment started.
- The pregnancy test within 24 hours previous to the first medication must be negative for women of childbearing. And all participants (male and female) should use effective contraception during the study period.
Who cannot join
- Pregnant or lactating women, or those who had a birth plan during the study period.
- Patients with neuropsychiatric disorders, especially depression, anxiety, mania, schizophrenia and other mental illness history or family history of mental illness.
- Patients with chronic liver disease caused by hepatitis A, hepatitis C, hepatitis E and/or HIV infection, or other causes (such as alcoholic hepatitis, drug-induced hepatitis, autoimmune liver disease, etc.).
- Evidence of acute severe liver damage: ALT>10 ULN, or markedly elevated ALT with significantly elevated bilirubin.
- Evidence of uncompensated liver disease: ascites, esophageal and gastric varices rupture bleeding, sepsis, hepatic encephalopathy, hepatorenal syndrome, etc. Or previous evidence of decompensation of cirrhosis.
- Patients with evidence of hepatocellular carcinoma or AFP>1 ULN.
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- Kidney diseases: acute or chronic nephritis, renal insufficiency, nephrotic syndrome, etc. Or serum creatinine >1 ULN at screening.
- Neutrophil count <1.5×10^9/L, platelet count <90×10^9/L, blood phosphorus < 0.8 mmol /L.
- Autoimmune diseases (such as psoriasis, systemic erythematosus, etc.), endocrine system diseases (such as thyroid diseases, diabetes, etc.), hypertension (blood pressure ≥140/90 mmHg) poorly controlled by prescription drugs, serious history of heart disease (especially in the past 6 months), severe retinopathy or other serious eye diseases. Patients with organic disease or dysfunction of other vital organs.
- Patients who plan to receive organ transplant or have already undergone organ transplant.
- Patients who allergic to the investigational drug or any of its excipients, or who meet any contraindication declared in the instructions of the investigational drug.
- Other conditions that are considered inappropriate for enrollment by the investigator.
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, 1 recruiting
- Recruiting
Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Qing Xie, MD, PhD., 0086-021-64370045 ext. 680403, xieqingrjh@163.com
Honglian Gui, MD,PhD, 0086-021-64370045 ext. 680419, lillian_ghl@163.com
About this study
Official title: A Prospective, Multicenter, Non-randomized, Controlled Study to Pursuit Clinical Functional Cure of Pegylated Interferon α in Previously Interferon-treated Chronic Hepatitis B （Leading Study）
Previous clinical practice and exploratory studies suggest that some patients who have not achieved functional cure in the first round of interferon therapy can achieve HBsAg clearance by interferon retreatment (intermittent therapy), which can reduce the occurrence of complications such as liver fibrosis, liver cirrhosis and liver cancer, and its clinical benefit is expected to be higher than that of NAs monotherapy.
This study is aimed to conduct a large-scale, multicenter, prospective study to confirm the benefit of peginterferon-based therapies in these populations. It expected to enroll about 2000 patients with chronic hepatitis B who have received prior interferon therapy and achieved a good response but without function cure, patients receive either interferon-based therapy or NAs monotherapy, according to their wishes and doctors' professional recommendations, with a ratio of 2:1 between the two groups, and all patients treated for 48 weeks. The HBsAg clearance rate before and after treatment, safety, etc. will be analyzed.
- Conditions
- Chronic Hepatitis b
- Being tested
- Peginterferon α-2b based treatment group, NAs monotherapy group
- Keywords
- CHB, peginterferon, functional cure, retreatment
- 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.
Peginterferon α-2b based treatment groupDrug
Peginterferon α-2b injection, 180mcg, s.c, once a week, for 48 weeks. If the baseline HBV DNA is higher than the minimum detection limit (using high-sensitivity kit), combined with nucleos(t)ide analogs (NAs) is recommended.
NAs monotherapy groupDrug
First-line NAs (e.g. Entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), tenofovir amibufenamide (TMF)), one tablet a day, take orally, for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Peginterferon α-2b based treatment group | Experimental | Not described Receives: Drug: Peginterferon α-2b based treatment group |
| NAs monotherapy group | Active comparator | Not described Receives: Drug: NAs monotherapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with HBsAg below the lower limit of detection.
Measured: Week 48
Secondary outcomes (7)
Decrease of HBV DNA levels at week 48 compared to baseline.
Measured: Week 48
Proportion of patients with HBV DNA below the lower limit of detection.
Measured: Week 48
Decrease of HBsAg levels at week 48 compared to baseline.
Measured: Week 48
Proportion of patients with HBsAg seroconversion.
Measured: Week 48
Proportion of patients with HBeAg below the lower limit of detection for patients with baseline HBeAg positive.
Measured: Week 48
Proportion of patients with HBeAg seroconversion for patients with baseline HBeAg positive.
Measured: Week 48
Serious adverse events.
Measured: from baseline to 48 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start4 Feb 2024
- Primary completionFeb 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,016 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qing XIe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qing XIe, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323681
- Sponsor's protocol ID
- Leading Study
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Non-randomized, Controlled Study to Pursuit Clinical Functional Cure of Pegylated Interferon α in Previously Interferon-treated Chronic Hepatitis B （Leading Study）
- ClinicalTrials.gov ID
- NCT06323681
- Acronym / sponsor ID
- Leading Study
- Conditions
- Chronic Hepatitis b
- Keywords
- CHB, peginterferon, functional cure, retreatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,016 participants (estimated)
- Lead sponsor
- Qing XIeUniversity, hospital or other
- Study start
- 4 Feb 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 21 Mar 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.
Previous clinical practice and exploratory studies suggest that some patients who have not achieved functional cure in the first round of interferon therapy can achieve HBsAg clearance by interferon retreatment (intermittent therapy), which can reduce the occurrence of complications such as liver fibrosis, liver cirrhosis and liver cancer, and its clinical benefit is expected to be higher than that of NAs monotherapy.
This study is aimed to conduct a large-scale, multicenter, prospective study to confirm the benefit of peginterferon-based therapies in these populations. It expected to enroll about 2000 patients with chronic hepatitis B who have received prior interferon therapy and achieved a good response but without function cure, patients receive either interferon-based therapy or NAs monotherapy, according to their wishes and doctors' professional recommendations, with a ratio of 2:1 between the two groups, and all patients treated for 48 weeks. The HBsAg clearance rate before and after treatment, safety, etc. will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peginterferon α-2b based treatment group | Experimental | Drug: Peginterferon α-2b based treatment group |
| NAs monotherapy group | Active comparator | Drug: NAs monotherapy group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Understand and sign the informed consent, participate in the study voluntarily.
- Aged between 18 and 65 (including 18 and 65).
- HBsAg positive for at least 6 months or other evidence suggests chronic hepatitis B.
- Had previously received interferon therapy, and discontinuation for at least 6 months at the time of enrollment, with a HBsAg level declined for at least 80% at the end of interferon treatment compared to the level of treatment started.
- HBsAg≤500 IU/mL at screening, and HBsAg rebound should not exceed 50% when compared to the HBsAg level of previously interferon treatment started.
Key exclusion criteria (12 listed)
- Pregnant or lactating women, or those who had a birth plan during the study period.
- Patients with neuropsychiatric disorders, especially depression, anxiety, mania, schizophrenia and other mental illness history or family history of mental illness.
- Patients with chronic liver disease caused by hepatitis A, hepatitis C, hepatitis E and/or HIV infection, or other causes (such as alcoholic hepatitis, drug-induced hepatitis, autoimmune liver disease, etc.).
- Evidence of acute severe liver damage: ALT>10 ULN, or markedly elevated ALT with significantly elevated bilirubin.
- Evidence of uncompensated liver disease: ascites, esophageal and gastric varices rupture bleeding, sepsis, hepatic encephalopathy, hepatorenal syndrome, etc. Or previous evidence of decompensation of cirrhosis.
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 α-2b based treatment groupPeginterferon α-2b injection, 180mcg, s.c, once a week, for 48 weeks. If the baseline HBV DNA is higher than the minimum detection limit (using high-sensitivity kit), combined with nucleos(t)ide analogs (NAs) is recommended. | Drug | Peginterferon α-2b based treatment group |
| NAs monotherapy groupFirst-line NAs (e.g. Entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), tenofovir amibufenamide (TMF)), one tablet a day, take orally, for 48 weeks. | Drug | NAs monotherapy group |
Primary outcome
Proportion of patients with HBsAg below the lower limit of detection.
Time frame: Week 48
7 secondary outcomes
Decrease of HBV DNA levels at week 48 compared to baseline.
Time frame: Week 48
Proportion of patients with HBV DNA below the lower limit of detection.
Time frame: Week 48
Decrease of HBsAg levels at week 48 compared to baseline.
Time frame: Week 48
Proportion of patients with HBsAg seroconversion.
Time frame: Week 48
Proportion of patients with HBeAg below the lower limit of detection for patients with baseline HBeAg positive.
Time frame: Week 48
Proportion of patients with HBeAg seroconversion for patients with baseline HBeAg positive.
Time frame: Week 48
Serious adverse events.
Time frame: from baseline to 48 weeks.
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 21 Mar 2024.
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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.
Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
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 α-2b based treatment group and NAs monotherapy group in people with Chronic Hepatitis b, run by Qing XIe 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 6 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: looking for participants now, as of the sponsor's last update on 21 Mar 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with HBsAg below the lower limit of detection. (time frame: Week 48). 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 21 Mar 2024.