Chronic Hepatitis BNCT06707922
A Follow-up Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B
A study testing Peginterferon α-2b Injection; Tenofovir Alafenamide Fumarate in people with Chronic Hepatitis B, run by Xiamen Amoytop Biotech Co., Ltd. at 30 sites in China.
Trial summary
Studies have shown that chronic hepatitis B patients with low levels of HBsAg after nucleos(t)ide analog therapy have a higher chance of functional cure with sequential or combined pegylated interferon therapy, with about 30-50% of patients achieving HBsAg clearance and discontinuing therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Peginterferon α-2b Injection; Tenofovir Alafenamide Fumarate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 30 sitesChina
- Study dates
- 18 Mar 2022to 31 Jul 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who completion of the TB1901IFN study ("completion" is defined as completion of more than 80% of trial medications (including peginterferon alfa and tenofovir disoproxil fumarate), or meeting criteria for early discontinuation and completion of consolidation therapy, as well as completion of discontinuation follow-up and 24-week post-discontinuation visit);
- Voluntary enrollment, understand and sign the informed consent form.
- For cohort 1 only; - Subjects who have achieved functional cure (defined as the disappearance of HBsAg at the completion of TB1901IFN, with or without the appearance of HBsAb);
- For cohort 2 only:
- At the completion of TB1901IFN, the S antigen level has decreased by ≥1 log compared to the baseline, with an S antigen level of less than 100 IU/ml, or the S antigen level has decreased by ≥1.5 log compared to the baseline, with an S antigen level of less than 1500 IU/ml;
- Willing to accept the treatment of peginterferon combined with TAF;
- For cohort 3 only:
- Participants who have not achieved functional cure upon completion of TB1901IFN (defined as HBsAg ≥ 0.05 IU/ml)；
Who cannot join
- Suspected or confirmed HCC patients.
- For Cohort 2 only:
- Suspected or confirmed liver cirrhosis.
- Pregnant, breastfeeding women, or those who plan to conceive during the combined medication treatment period.
- Evidence of acute severe liver injury: e.g. ALT > 10 times of the upper limit of normal (ULN), or a significant increase in ALT accompanied by a significant increase in bilirubin;
- Evidence of decompensated liver disease: serum total bilirubin > 2ULN, serum albumin < 35 g/L, prothrombin time extended by more than 3 seconds beyond ULN, prothrombin activity < 60%; or a history of decompensated liver cirrhosis;
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- Kidney disease: acute or chronic nephritis, renal insufficiency, nephrotic syndrome, etc., or serum creatinine > 1ULN;
- Neutrophil count < 1.5×10^9/L, platelet count < 90×10^9/L;
- Severe retinopathy or other severe ophthalmic diseases;
- Other conditions deemed by the investigator to be unsuitable for participation in the cohort 2.
- For cohort 3 only:
- Participants who plan to enter Cohort 2.
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
China30 sites
Peking University First Hospital
Beijing, 100034
Beijing Youan Hospital, Capital Medical University
Beijing
The fifth medical center of PLA General Hospital
Beijing
The Second Xiangya Hospital of Central South University
Changsha
Xiangya Hospital Central South University
Changsha
Public Health Clinical Center of Chengdu
Chengdu
Sichuan Provincial People's Hospital
Chengdu
Mengchao Hepatobiliary Hosipital of Fujian Medical University
Fuzhou
The First Affiliated Hospital of Fujian Medical University
Fuzhou
Guangzhou Eighth People's Hospital
Guangzhou
The Third Affiliated Hospital,SUN YAT-SEN University
Guanzhou
The Fourth Affiliated Hospital of Harbin Medical University
Harbin
The First Affiliated Hospital of Anhui Medical University
Hefei
Huashan Hospital ,Fudan University
Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
The Sixth People's Hospital of Shenyang
Shenyang
Peiking University Shenzhen Hospital
Shenzhen
The Third People's Hospital of shenzhen
Shenzhen
The First Hospital of Shanxi Medical University
Taiyuan
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin
Tianjin Third Central Hospital
Tianjin
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi
Traditional Chinese Medical hospital of Xinjiang Uygur Autonomous Region
Ürümqi
Tongji Hospital,Tongji Medical College Huazhong University of Science and Technology
Wuhan
Tangdu Hospital,Air Force Medical University
Xi'an
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
The First Affiliated Hospital of Xiamen University
Xiamen
Xiamen Hospital of Traditional Chinese Medicine
Xiamen
Yanbian University Hospital/Yanbian Hospital
Yanji
Henan Provincial People's Hospital
Zhengzhou
About this study
Official title: A Multicenter, Prospective, Follow-up Study to Evaluate the Long-term Benefits of Peginterferon Alpha-2b Injection Combined With TDF in Patients With Chronic Hepatitis B
Studies have shown that chronic hepatitis B patients with low levels of HBsAg after nucleos(t)ide analog therapy have a higher chance of functional cure with sequential or combined pegylated interferon therapy, with about 30-50% of patients achieving HBsAg clearance and discontinuing therapy.
There are some clinical practices on the long-term benefits of discontinuing antiviral therapy, but there is a lack of evidence-based clinical studies, especially on the relapse rate, duration of relapse, and factors influencing relapse after achieving functional cure. Furthermore, there is no guideline or expert consensus on the follow-up management strategy for patients who haven't achieved functional cure but whose HBsAg levels have been substantially reduced by treatment and are at low levels.
Therefore, this study is planned to enroll participants who have completed the TB1901IFN to evaluate the long-term benefit of Peginterferon in combination with tenofovir disoproxil fumarate（TDF） and relapse in patients who have achieved functional cure, for participant with low-level HBsAg at the end of treatment, peginterferon combined with tenofovir alafenamide fumarate （TAF）therapy will be administered to explore the efficacy and safety of starting treatment after a period of drug discontinuation. Participants will be divided into 3 cohorts based on functional achievement and/or HBsAg levels after completion of TB1901IFN
- Conditions
- Chronic Hepatitis B
- Being tested
- Peginterferon α-2b Injection; Tenofovir Alafenamide Fumarate
- Keywords
- Peginterferon Alfa, Tenofovir Disoproxil Fumarate, Relapse, Retreatment
- Medical subject headings
- Hepatitis B, Chronic, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon α-2b Injection; Tenofovir Alafenamide FumarateDrug
Peginterferon α-2b Injection, subcutaneous injection, once a week. Tenofovir Alafenamide Fumarate, Oral administration, once a day.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | No intervention | Participants who have achieved functional cure at the time of completion of TB1901IFN will be included and followed up for 5 years without any intervention. |
| Cohort 2 | Experimental | Participants with S antigen decrease≥1log and the S antigen level <100IU/ml at enrollment, or who with S antigen decrease ≥1.5log and the S antigen level <1500IU/ml after TB1901IFN treatment, will initially treated with 72-week pulse treatment of peginterferon in combination with TAF, and then followed up to 5 years. Receives: Drug: Peginterferon α-2b Injection; Tenofovir Alafenamide Fumarate |
| Cohort 3 | No intervention | Except for those who already enrollment in Cohort 2, Participants with functional cure achievement will enroll in Cohort 3, and follow-up for 5 years without any study intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Hepatocellular Carcinoma(HCC).
Measured: 5 years after the completion of the TB1901IFN study.
The incidence all-cause mortality.
Measured: 5 years after the completion of the TB1901IFN study.
Relapse within 5 years of discontinuation in participants who achieved functional cure.
Relapse was defined as the occurrence of two consecutive time, interval greater than one month, HBsAg≥0.05 IU/ml at any time during the follow-up period
Measured: 5 years after the completion of the TB1901IFN study.
Rate of functional cure of re-initiation of combination therapy after discontinued for more than 24 weeks in participants who had a favorable outcome on prior therapy and obtained low levels of S antigen.
Measured: After completing the 72-week combined re-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start18 Mar 2022
- Primary completion31 May 2029 (estimated)
- Study completion31 Jul 2029 (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.
- More trials run by Xiamen Amoytop Biotech Co., Ltd.The sponsor's other registered studies.
- 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University First Hospital
- Responsible party
- Sponsor
- Investigators
- Guiqiang Wang, Ph.D, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707922
- Sponsor's protocol ID
- TB2111IFN
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- 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 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Follow-up Study to Evaluate the Long-term Benefits of Peginterferon Alpha-2b Injection Combined With TDF in Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT06707922
- Acronym / sponsor ID
- TB2111IFN
- Conditions
- Chronic Hepatitis B
- Keywords
- Peginterferon Alfa, Tenofovir Disoproxil Fumarate, Relapse, Retreatment
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking University First Hospital
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 27 Nov 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.
Studies have shown that chronic hepatitis B patients with low levels of HBsAg after nucleos(t)ide analog therapy have a higher chance of functional cure with sequential or combined pegylated interferon therapy, with about 30-50% of patients achieving HBsAg clearance and discontinuing therapy.
There are some clinical practices on the long-term benefits of discontinuing antiviral therapy, but there is a lack of evidence-based clinical studies, especially on the relapse rate, duration of relapse, and factors influencing relapse after achieving functional cure. Furthermore, there is no guideline or expert consensus on the follow-up management strategy for patients who haven't achieved functional cure but whose HBsAg levels have been substantially reduced by treatment and are at low levels.
Therefore, this study is planned to enroll participants who have completed the TB1901IFN to evaluate the long-term benefit of Peginterferon in combination with tenofovir disoproxil fumarate（TDF） and relapse in patients who have achieved functional cure, for participant with low-level HBsAg at the end of treatment, peginterferon combined with tenofovir alafenamide fumarate （TAF）therapy will be administered to explore the efficacy and safety of starting treatment after a period of drug discontinuation. Participants will be divided into 3 cohorts based on functional achievement and/or HBsAg levels after completion of TB1901IFN
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | No intervention | –Participants who have achieved functional cure at the time of completion of TB1901IFN will be included and followed up for 5 years without any intervention. |
| Cohort 2 | Experimental | Drug: Peginterferon α-2b Injection; Tenofovir Alafenamide FumarateParticipants with S antigen decrease≥1log and the S antigen level <100IU/ml at enrollment, or who with S antigen decrease ≥1.5log and the S antigen level <1500IU/ml after TB1901IFN treatment, will initially treated with 72-week pulse treatment of peginterferon in combination with TAF, and then followed up to 5 years. |
| Cohort 3 | No intervention | –Except for those who already enrollment in Cohort 2, Participants with functional cure achievement will enroll in Cohort 3, and follow-up for 5 years without any study intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants who completion of the TB1901IFN study ("completion" is defined as completion of more than 80% of trial medications (including peginterferon alfa and tenofovir disoproxil fumarate), or meeting criteria for early discontinuation and completion of consolidation therapy, as well as completion of discontinuation follow-up and 24-week post-discontinuation visit);
- Voluntary enrollment, understand and sign the informed consent form.
- For cohort 1 only; - Subjects who have achieved functional cure (defined as the disappearance of HBsAg at the completion of TB1901IFN, with or without the appearance of HBsAb);
- At the completion of TB1901IFN, the S antigen level has decreased by ≥1 log compared to the baseline, with an S antigen level of less than 100 IU/ml, or the S antigen level has decreased by ≥1.5 log compared to the baseline, with an S antigen level of less than 1500 IU/ml;
- Willing to accept the treatment of peginterferon combined with TAF;
Key exclusion criteria (12 listed)
- Suspected or confirmed HCC patients.
- Suspected or confirmed liver cirrhosis.
- Pregnant, breastfeeding women, or those who plan to conceive during the combined medication treatment period.
- Evidence of acute severe liver injury: e.g. ALT > 10 times of the upper limit of normal (ULN), or a significant increase in ALT accompanied by a significant increase in bilirubin;
- Evidence of decompensated liver disease: serum total bilirubin > 2ULN, serum albumin < 35 g/L, prothrombin time extended by more than 3 seconds beyond ULN, prothrombin activity < 60%; or a history of decompensated liver 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 Injection; Tenofovir Alafenamide FumaratePeginterferon α-2b Injection, subcutaneous injection, once a week. Tenofovir Alafenamide Fumarate, Oral administration, once a day. | Drug | Cohort 2 |
Primary outcome
The incidence of Hepatocellular Carcinoma(HCC).
Time frame: 5 years after the completion of the TB1901IFN study.
The incidence all-cause mortality.
Time frame: 5 years after the completion of the TB1901IFN study.
Relapse within 5 years of discontinuation in participants who achieved functional cure.
Time frame: 5 years after the completion of the TB1901IFN study.
Relapse was defined as the occurrence of two consecutive time, interval greater than one month, HBsAg≥0.05 IU/ml at any time during the follow-up period
Rate of functional cure of re-initiation of combination therapy after discontinued for more than 24 weeks in participants who had a favorable outcome on prior therapy and obtained low levels of S antigen.
Time frame: After completing the 72-week combined re-treatment.
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 4 Dec 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.
Guiqiang Wang, Ph.D principal investigator
Peking University First Hospital
30 sites 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 Injection; Tenofovir Alafenamide Fumarate in people with Chronic Hepatitis B, run by Xiamen Amoytop Biotech Co., Ltd. at 30 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 8 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: enrolling by invitation, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of Hepatocellular Carcinoma(HCC). (time frame: 5 years after the completion of the TB1901IFN study.). 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 4 Dec 2024.