Hepatitis BNCT03181113
Long-term Benefit in Chronic Hepatitis B Patients After Standard Peginterferon Alfa Therapy
An observational study of Hepatitis B, run by Xiamen Amoytop Biotech Co., Ltd. at 28 sites in China.
Trial summary
In this cohort study, patients with chronic hepatitis B who prior participated in TB1211IFN study and received at least 39 doses of peginterferon alfa will be enrolled. HBsAg/anti-HBs level, HBeAg/anti-HBe level, Serum HBV DNA load and alanine transaminase level will be test every year from the second year to the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Peginterferon Alfa-2B and Peginterferon Alfa-2A
- How many people
- 473 participants
- Where
- 28 sitesChina
- Study dates
- 18 May 2016to 21 Sep 2020
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic hepatitis B who previously participated in TB1211IFN study.
Who may be able to join
- Understand and sign the informed consent form.
- Participated in NCT01760122 study (TB1211IFN) and has received at least 39 doses of peginterferon.
Who cannot join
- Conditions which in the opinion of the investigator should be precluded from the study(e.g., poor compliance).
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
China28 sites
302 Military Hospital
Beijing, Beijing Municipality
Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality
Peking University First Hospital
Beijing, Beijing Municipality
Peking University People's Hospital
Beijing, Beijing Municipality
Xiangya Hospital, Central-south University
Changsha, Hunan
Xiangya Second Hospital, Central-south University
Changsha, Hunan
Second Affiliated Hospital Chongqing Medical University
Chongqing, Chongqing Municipality
Southwest Hospital
Chongqing, Chongqing Municipality
Fuzhou Infectious Disease Hospital
Fuzhou, Fujian
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong
Nanfang Hospital
Guangzhou, Guangdong
Jinan Infectious Disease Hospital
Jinan, Shandong
First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
81 Military Hospital
Nanjing, Jiangsu
Second Hospital of Nanjing
Nanjing, Jiangsu
85 Military Hospital
Shanghai, Shanghai Municipality
Huashan Hospital
Shanghai, Shanghai Municipality
Ruijing Hospital
Shanghai, Shanghai Municipality
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality
Shenyang Sixth People's Hospital
Shenyang, Liaoning
Beijing University Shenzhen Hospital
Shenzhen, Guangdong
Third Affiliated Hospital, Hebei Medical University
Shijiazhuang, Hebei
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality
First Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Xiamen Hospital of T.C.M
Xiamen, Fujian
Henan Provincial People's Hospital
Zhengzhou, Henan
About this study
Official title: A Multi-center, Prospective Study to Acess Long-term Benefit in HBeAg Positive Chronic Hepatitis B Patients Who Previously Received Standard Peginterferon Alfa Therapy
In this cohort study, patients with chronic hepatitis B who prior participated in TB1211IFN study and received at least 39 doses of peginterferon alfa will be enrolled. HBsAg/anti-HBs level, HBeAg/anti-HBe level, Serum HBV DNA load and alanine transaminase level will be test every year from the second year to the fifth year after the ending of peginterferon alfa treatment, and long-term benefit of interferon treatment will be evaluated.
- Conditions
- Hepatitis B
- Being tested
- Peginterferon Alfa-2B, Peginterferon Alfa-2A
- Keywords
- peginterferon alpha, HBeAg seroconversion, immune control
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon Alfa-2BDrug
Also called pegberon
pre-received standard peginterferon alfa-2b therapy
Peginterferon Alfa-2ADrug
Also called pegasys
pre-received standard peginterferon alfa-2a therapy
| Study group | Role | What they receive |
|---|---|---|
| peginterferon alfa 2b | Not described Receives: Drug: Peginterferon Alfa-2B | |
| peginterferon alfa 2a | Not described Receives: Drug: Peginterferon Alfa-2A |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of HBeAg seroconversion
Measured: from the second year to the fifth year
Secondary outcomes (6)
decent degree of HBeAg
Measured: from the second year to the fifth year
decent degree of HBV DNA
Measured: from the second year to the fifth year
rate of alanine aminotransferase normalization
Measured: from the second year to the fifth year
rate of HBeAg loss
Measured: from the second year to the fifth year
rate of HBV DNA undetectable
Measured: from the second year to the fifth year
rate of HBeAg seroconversion
Measured: from the second year to the fifth year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start18 May 2016
- Primary completion21 Sep 2020
- Study completion21 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 473 participants (actual)
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, MD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181113
- Sponsor's protocol ID
- TB1510IFN
- Status last verified
- Apr 2021
- First submitted
- 6 Jun 2017
- Last updated
- 13 Apr 2021
- 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 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective Study to Acess Long-term Benefit in HBeAg Positive Chronic Hepatitis B Patients Who Previously Received Standard Peginterferon Alfa Therapy
- ClinicalTrials.gov ID
- NCT03181113
- Acronym / sponsor ID
- TB1510IFN
- Conditions
- Hepatitis B
- Keywords
- peginterferon alpha, HBeAg seroconversion, immune control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 473 participants (actual)
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking University First Hospital
- Study start
- 18 May 2016 (actual)
- Primary completion
- 21 Sep 2020 (actual)
- Study completion
- 21 Sep 2020 (actual)
- First posted
- 8 Jun 2017 (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.
In this cohort study, patients with chronic hepatitis B who prior participated in TB1211IFN study and received at least 39 doses of peginterferon alfa will be enrolled. HBsAg/anti-HBs level, HBeAg/anti-HBe level, Serum HBV DNA load and alanine transaminase level will be test every year from the second year to the fifth year after the ending of peginterferon alfa treatment, and long-term benefit of interferon treatment will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| peginterferon alfa 2b | – | Drug: Peginterferon Alfa-2B |
| peginterferon alfa 2a | – | Drug: Peginterferon Alfa-2A |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic hepatitis B who previously participated in TB1211IFN study.
Key inclusion criteria (2 listed)
- Understand and sign the informed consent form.
- Participated in NCT01760122 study (TB1211IFN) and has received at least 39 doses of peginterferon.
Key exclusion criteria (1 listed)
- Conditions which in the opinion of the investigator should be precluded from the study(e.g., poor compliance).
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-2BAlso: pegberonpre-received standard peginterferon alfa-2b therapy | Drug | peginterferon alfa 2b |
| Peginterferon Alfa-2AAlso: pegasyspre-received standard peginterferon alfa-2a therapy | Drug | peginterferon alfa 2a |
Primary outcome
rate of HBeAg seroconversion
Time frame: from the second year to the fifth year
6 secondary outcomes
decent degree of HBeAg
Time frame: from the second year to the fifth year
decent degree of HBV DNA
Time frame: from the second year to the fifth year
rate of alanine aminotransferase normalization
Time frame: from the second year to the fifth year
rate of HBeAg loss
Time frame: from the second year to the fifth year
rate of HBV DNA undetectable
Time frame: from the second year to the fifth year
rate of HBeAg seroconversion
Time frame: from the second year to the fifth year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- 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. This study is not recruiting at the moment.
Guiqiang Wang, MD principal investigator
Peking University First Hospital
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, run by Xiamen Amoytop Biotech Co., Ltd. at 28 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
rate of HBeAg seroconversion (time frame: from the second year to the fifth year). 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 13 Apr 2021; AzTrials last refreshed its copy on 1 Nov 2026.