Chronic Hepatitis BNCT05671315
A Prospective Study to Evaluate Peginterferon in Reducing the Incidence of HCC in CHB Patients
A study testing Peginterferon alfa-2b Injection, Nucleos (t) ide Analogue and Nucleos(t)ide analogue in people with Chronic Hepatitis B and Intermediate to High Risk of HCC, run by Qing XIe at 9 sites in China.
Trial summary
China's new cases and deaths of hepatocellular carcinoma (HCC) rank first in the world. hepatocellular carcinoma is the third most morbid, second-most mortal malignancy in China. Up to 80% of hepatocellular carcinoma patients caused by HBV infection. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Hepatitis B, Intermediate to High Risk of HCC
- What is being tested?
- Peginterferon alfa-2b Injection, Nucleos (t) ide Analogue and Nucleos(t)ide analogue
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 9 sitesChina
- Study dates
- 3 Jul 2019to Apr 2026
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18 to 60 years and no gender limit (including 18 and 60 years).
- HBsAg positive for more than 6 months.
- Patients with intermediate to high liver cancer risks. Refers to if at least one of the following items is met.
- Male patient aged above 40 years.
- Patients with a history of cirrhosis and/or family history of liver cancer.
- Patients with metabolic diseases, such as diabetes, fatty liver, etc.
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- Any liver cancer assessment model of chronic hepatitis B patients suggested that liver cancer was at intermediate to high risk.
- Have received Nucleos(t)ide analogue treatment for more than 24 weeks, and currently receiving Nucleos(t)ide analogue, while HBV DNA is undetectable (HBV DNA below 300 IU/mL or 1000 copies/mL).
- Urine and/or serum pregnancy test within 24 hours prior to the first dose must be negative for female patients of childbearing potential.
- Understand and voluntarily sign informed consent form.
Who cannot join
- Patients co-infected with active hepatitis A, hepatitis C, hepatitis D, hepatitis E or HIV.
- Patients who have previously received interferon therapy.
- Alpha-fetoprotein greater than 100 ng/mL at screening, or liver imaging suggestive of liver tumor.
- Decompensated liver disease (Child-Pugh score ≥ 5).
- Pregnant or lactating women or patients planning to become pregnant or cannot to take contraception during the study.
- Neutrophil count < 1.5 x 109/L, platelet count < 90 x 109 cells/L, or Creatinine 1.5 times higher than the upper limit of normal.
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- Patients with severe psychiatric history, particularly depression.
- History of immune-mediated disease or levels of autoimmune antibodies markedly elevated.
- Patients with severe diseases in major organ, such as heart, lung, kidney, brain, blood, etc., and patients with malignancies.
- Patients with poorly controlled diabetes, hypertension, and thyroid disease.
- Patients with history of severe retinopathy or other evidence of retinopathy.
- Patient who ever received organ transplantation, or planning to receive organ transplantation.
- Patients who are allergic to interferon or any of its ingredients.
- Other circumstances that the investigator deems inappropriate to participate in this study.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
The Public Health Clinical Center Of Chengdu
Chengdu
Yilan Zeng, 2499081791@qq.com
- Recruiting
The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei
Yi Li, liyily2008@sina.com
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao
Yuan Guo
- Recruiting
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai
Qing Xie
- Recruiting
Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine
Shanghai
Jie Xu, dr.xu@aliyun.com
- Recruiting
Tongren Hospital Shanghai Jiao Tong University School of Medicine
Shanghai
Qin Zhang, zhangq1030@163.com
- Recruiting
The Fifth People's Hospital Of Suzhou
Suzhou
Chuanwu Zhu, zhuchw@126.com
- Recruiting
Xiamen Hospital of Traditional Chinese Medicin
Xiamen
Lijuan Ouyang, oylj_1105@163.com
- Recruiting
The Tirth Affiliated Hospital Of Xinxiang Medical University
Xinxiang
Weifeng Zhao, zwf7577@126.com
About this study
Official title: A Prospective, Randomized, Open-label, Multicenter Study to Evaluate the Peginterferon, Comparing to Nucleos(t)Ide Analogues, in Reducing the Incidence of HCC in Chronic Hepatitis B Patients With Intermediate to High Liver Cancer Risks
China's new cases and deaths of hepatocellular carcinoma (HCC) rank first in the world. hepatocellular carcinoma is the third most morbid, second-most mortal malignancy in China. Up to 80% of hepatocellular carcinoma patients caused by HBV infection. Antiviral therapy can significantly reduce the incidence and mortality of hepatocellular carcinoma in patients with chronic hepatitis B (CHB), hinder the progression of liver disease, and effectively control the disease. However, studies in recent years have found that long-term therapy with Nucleos(t)ide analogue (NAs) cannot completely eliminate the risk of liver cancer in patients with chronic hepatitis B. In addition, a number of retrospective studies at home and abroad have shown that compared with long-term oral NAs, peginterferon can significantly reduce the risk of hepatocellular carcinoma in patients with chronic hepatitis B. However, there is limit prospective studies.
This multicenter, randomized, open-label, controlled trial study is aim to evaluate the pegylated interferon alfa-2b injection in comparing to NAs in reducing the incidence of hepatocellular carcinoma, to provide evidences for new management and treatment strategy options for improving clinical outcomes for the chronic hepatitis B patients. About 267 chronic hepatitis patients with intermediate to high risk of liver cancer who are now receiving nucleoside therapy will be enrolled. Subjects will be randomized into the peginterferon combined NAs group and the NAs monotherapy group at a ratio of 2:1. Level of HBsAg, proportion of patients with HBsAg clearance and seroconversion, incidence of liver cirrhosis and hepatocellular carcinoma will be assessed.
- Being tested
- Peginterferon alfa-2b Injection, Nucleos (t) ide Analogue, Nucleos(t)ide analogue
- Keywords
- Chronic Hepatitis B, Hepatocellular Carcinoma, Peginterferon, Nucleos(t)ide analogue
- Medical subject headings
- Hepatitis B, Chronic, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa-2b Injection, Nucleos (t) ide AnalogueDrug
1.Peginterferon alfa-2b injection: 180μg, subcutaneously inject, once a week, from week 1 to Week 48.
2, NAs: Dose please follow the approved dosage, once daily, from the first day until when discontinuation is indicated.
NAs Discontinuation Criteria: A total course of treatment is recommended for at least 4 years, and discontinuation may be considered if HBV DNA is below the lower limit of detection, Alanine aminotransferase renormalization, and HBeAg serological conversion, and remain unchanged (test every 6 months) during a consolidation therapy for at least 3 years. However, a prolonged course of treatment may reduce relapse.
Nucleos(t)ide analogueDrug
NAs: Dose please follow the approved dosage, once daily, from the first day until when discontinuation is indicated.
NAs Discontinuation Criteria: A total course of treatment is recommended for at least 4 years, and discontinuation may be considered if HBV DNA is below the lower limit of detection, Alanine aminotransferase renormalization, and HBeAg serological conversion, and remain unchanged (test every 6 months) during a consolidation therapy for at least 3 years. However, a prolonged course of treatment may reduce relapse.
| Study group | Role | What they receive |
|---|---|---|
| Combined treatment group | Experimental | Peginterferon alfa-2b Injection combined Nucleos (t) ide Analogue therapy Receives: Drug: Peginterferon alfa-2b Injection, Nucleos (t) ide Analogue |
| Monotherapy group | Active comparator | Nucleos (t) ide Analogue monotherapy Receives: Drug: Nucleos(t)ide analogue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of HBsAg level compared to baseline
Measured: week 48 of treatment
Secondary outcomes (4)
Proportion of patients with HBsAg clearance
Measured: At week 48 of treatment and 5 years of follow up
Proportion of patients with HBsAg seroconversion
Measured: At week 48 of treatment and 5 years of follow up
Proportion of patients with change of liver stiffness measurement (LSM)
Measured: At week 48 of treatment and 5 years of follow up
Incidence of liver cirrhosis and hepatocellular carcinoma
Measured: At week 48 of treatment and 5 years of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start3 Jul 2019
- Primary completionAug 2023 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 267 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qing XIe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qing XIe, Ruijin Hospital
- Investigators
- Qing Xie, Principal investigator, Ruijin Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671315
- Sponsor's protocol ID
- Paradise
- Status last verified
- May 2023
- First submitted
- 15 Mar 2020
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jiang S, Guo S, Huang Y, Xu J, Li Y, Zeng Y, Guo Y, Ouyang L, Zhu C, Zhao W, Zhang Q, Guo Q, Xin H, Xie Q. Interim analysis of the PARADISE study: Benefits of add-on peginterferon-alpha in NA-treated patients with CHB. Antiviral Res. 2024 Jun;226:105892. doi: 10.1016/j.antiviral.2024.105892. Epub 2024 Apr 23.
PubMed 38663455
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-label, Multicenter Study to Evaluate the Peginterferon, Comparing to Nucleos(t)Ide Analogues, in Reducing the Incidence of HCC in Chronic Hepatitis B Patients With Intermediate to High Liver Cancer Risks
- ClinicalTrials.gov ID
- NCT05671315
- Acronym / sponsor ID
- Paradise
- Keywords
- Chronic Hepatitis B, Hepatocellular Carcinoma, Peginterferon, Nucleos(t)ide analogue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 267 participants (estimated)
- Lead sponsor
- Qing XIeUniversity, hospital or other
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 4 Jan 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.
China's new cases and deaths of hepatocellular carcinoma (HCC) rank first in the world. hepatocellular carcinoma is the third most morbid, second-most mortal malignancy in China. Up to 80% of hepatocellular carcinoma patients caused by HBV infection. Antiviral therapy can significantly reduce the incidence and mortality of hepatocellular carcinoma in patients with chronic hepatitis B (CHB), hinder the progression of liver disease, and effectively control the disease. However, studies in recent years have found that long-term therapy with Nucleos(t)ide analogue (NAs) cannot completely eliminate the risk of liver cancer in patients with chronic hepatitis B. In addition, a number of retrospective studies at home and abroad have shown that compared with long-term oral NAs, peginterferon can significantly reduce the risk of hepatocellular carcinoma in patients with chronic hepatitis B. However, there is limit prospective studies.
This multicenter, randomized, open-label, controlled trial study is aim to evaluate the pegylated interferon alfa-2b injection in comparing to NAs in reducing the incidence of hepatocellular carcinoma, to provide evidences for new management and treatment strategy options for improving clinical outcomes for the chronic hepatitis B patients. About 267 chronic hepatitis patients with intermediate to high risk of liver cancer who are now receiving nucleoside therapy will be enrolled. Subjects will be randomized into the peginterferon combined NAs group and the NAs monotherapy group at a ratio of 2:1. Level of HBsAg, proportion of patients with HBsAg clearance and seroconversion, incidence of liver cirrhosis and hepatocellular carcinoma will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined treatment group | Experimental | Drug: Peginterferon alfa-2b Injection, Nucleos (t) ide AnaloguePeginterferon alfa-2b Injection combined Nucleos (t) ide Analogue therapy |
| Monotherapy group | Active comparator | Drug: Nucleos(t)ide analogueNucleos (t) ide Analogue monotherapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Aged 18 to 60 years and no gender limit (including 18 and 60 years).
- HBsAg positive for more than 6 months.
- Patients with intermediate to high liver cancer risks. Refers to if at least one of the following items is met.
- Have received Nucleos(t)ide analogue treatment for more than 24 weeks, and currently receiving Nucleos(t)ide analogue, while HBV DNA is undetectable (HBV DNA below 300 IU/mL or 1000 copies/mL).
- Urine and/or serum pregnancy test within 24 hours prior to the first dose must be negative for female patients of childbearing potential.
Key exclusion criteria (14 listed)
- Patients co-infected with active hepatitis A, hepatitis C, hepatitis D, hepatitis E or HIV.
- Patients who have previously received interferon therapy.
- Alpha-fetoprotein greater than 100 ng/mL at screening, or liver imaging suggestive of liver tumor.
- Decompensated liver disease (Child-Pugh score ≥ 5).
- Pregnant or lactating women or patients planning to become pregnant or cannot to take contraception during the 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 |
|---|---|---|
| Peginterferon alfa-2b Injection, Nucleos (t) ide Analogue1.Peginterferon alfa-2b injection: 180μg, subcutaneously inject, once a week, from week 1 to Week 48. 2, NAs: Dose please follow the approved dosage, once daily, from the first day until when discontinuation is indicated. NAs Discontinuation Criteria: A total course of treatment is recommended for at least 4 years, and discontinuation may be considered if HBV DNA is below the lower limit of detection, Alanine aminotransferase renormalization, and HBeAg serological conversion, and remain unchanged (test every 6 months) during a consolidation therapy for at least 3 years. However, a prolonged course of treatment may reduce relapse. | Drug | Combined treatment group |
| Nucleos(t)ide analogueNAs: Dose please follow the approved dosage, once daily, from the first day until when discontinuation is indicated. NAs Discontinuation Criteria: A total course of treatment is recommended for at least 4 years, and discontinuation may be considered if HBV DNA is below the lower limit of detection, Alanine aminotransferase renormalization, and HBeAg serological conversion, and remain unchanged (test every 6 months) during a consolidation therapy for at least 3 years. However, a prolonged course of treatment may reduce relapse. | Drug | Monotherapy group |
Primary outcome
Change of HBsAg level compared to baseline
Time frame: week 48 of treatment
4 secondary outcomes
Proportion of patients with HBsAg clearance
Time frame: At week 48 of treatment and 5 years of follow up
Proportion of patients with HBsAg seroconversion
Time frame: At week 48 of treatment and 5 years of follow up
Proportion of patients with change of liver stiffness measurement (LSM)
Time frame: At week 48 of treatment and 5 years of follow up
Incidence of liver cirrhosis and hepatocellular carcinoma
Time frame: At week 48 of treatment and 5 years of follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Derived from this study: PubMed 38663455Jiang S, Guo S, Huang Y, Xu J, Li Y, Zeng Y, Guo Y, Ouyang L, Zhu C, Zhao W, Zhang Q, Guo Q, Xin H, Xie Q. Interim analysis of the PARADISE study: Benefits of add-on peginterferon-alpha in NA-treated patients with CHB. Antiviral Res. 2024 Jun;226:105892. doi: 10.1016/j.antiviral.2024.105892. Epub 2024 Apr 23.
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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 Xie principal investigator
Ruijin Hospital, Shanghai
9 sites 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 Injection, Nucleos (t) ide Analogue and Nucleos(t)ide analogue in people with Chronic Hepatitis B and Intermediate to High Risk of HCC, run by Qing XIe at 9 sites 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 10 inclusion and 14 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 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 Qing Xie, Ph.D (86-13651804273, profxieqing@163.com;xieqingrjh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of HBsAg level compared to baseline (time frame: week 48 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05671315, which also lists 1 linked publication.
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 25 May 2023.