Hepatitis BIFNA2/ISGsNCT03771677
To Optimize the Therapeutic Pathway of Peginterferon Treatment in Patients With CHB Based on IFNA2p.Ala120Thr /ISGs.
A study testing Nucleotide Analog and Interferon Alfa-2A in people with Hepatitis B, run by Sun Yat-sen University at 1 site in China.
Trial summary
The study is to guide clinical cure of peginterferon alfa-2a treatment in patients with chronic hepatitis B based on the detection of interferon gene mutation (IFNA2p.Ala120Thr) and interferon-stimulated genes (ISGs) detection gene spectrum. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Nucleotide Analog and Interferon Alfa-2A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 30 Dec 2024
- 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
- Age between 18 and 60 years old;
- HBsAg positive, HBsAg quantification≤1500 IU/mL;
- Serum HBV DNA quantification <100 IU/mL;
- HBeAg negative.
Who cannot join
- Treated with interferon in the past six months;
- Liver cirrhosis or HCC and other associated tumors;
- Women during pregnancy or lactation;
- With liver disease caused by other causes;
- Combination infection of HIV or other immunodeficiency diseases;
- With diabetes, autoimmune diseases and other organ dysfunction or failure;
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- Combination of other serious complications (infection, hepatic encephalopathy,gastrointestinal bleeding, hepatorenal syndrome, etc.);
- Others who cannot be treated with interferon;
- Anyone cannot return to the hospital for follow-up and follow-up visits regularly as planned
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chan Xie
Guangzhou, Guangdong, 510000
Chan Xie, Professor, 862085252043, happyxiechan@hotmail.com
About this study
Official title: A Clinical Controlled Study to Optimize the Therapeutic Pathway of Peginterferon Alfa-2b Treatment in Patients With Chronic Hepatitis B Based on IFNA2p.Ala120Thr /ISGs Gene Spectrum.
The study is to guide clinical cure of peginterferon alfa-2a treatment in patients with chronic hepatitis B based on the detection of interferon gene mutation (IFNA2p.Ala120Thr) and interferon-stimulated genes (ISGs) detection gene spectrum.
Read the detailed description
It is estimated that more than 400 million people are infected with hepatitis B virus (HBV) globally.How to make more patients with chronic hepatitis B get clinical treatment through the existing anti-viral treatment is an urgent problem to be solved.This study is a random, multi-center and open experiment,the collaborators includes the second people's hospital of zhongshan city, the eighth people's hospital of guangzhou city, and the first people's hospital of foshan city.
Patients with chronic hepatitis B who were treated with NAs for over 1 year,HBsAg quantification≤1500 IU/mL, HBeAg negative and serum HBV DNA quantification <100 IU/mL were enrolled in this study. In our study, the enrolled patient's IFNA2p.Ala120Thr without variation and ISGs>0.05 were divided into two groups. After informed consent , patients were grouped according to their treatment intentions,in one group, patients continued NAs for another 48 weeks. In another group , patients were treated with peg-interferon-2a and NAs for 48 weeks.Patient's BMI, genotype, family history, smoking history, drinking history, other medical history, suspected transmission channels, types and time of use were recorded in this study.Moreover, Patients were assessed every 12 weeks,included liver and kidney function, blood routine, HBV cccDNA, HBeAg quantification, HBsAg quantification, pgRNA and so on.In addition,liver imaging examination and liver hardness test were assessed every six months.
In this study, we will analyze whether clinical cure rates differed between patients with chronic hepatitis B treated with peginterferon alfa-2a and NAs;Bisedes,the baseline interferon variant site variants and changes in interferon-stimulated gene profile expression were analyzed to determine whether they could be used as molecular markers to predict clinical cure with interferon.
- Conditions
- Hepatitis B
- Being tested
- Nucleotide Analog, Interferon Alfa-2A
- Keywords
- Chronic Hepatitis B, IFNA2p.Ala120Thr /ISGs
- Medical subject headings
- Hepatitis B, Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nucleotide AnalogDrug
Also called Nucleotide Analogs
such as Entecavir,entecavir 0.5mg per day
Interferon Alfa-2ADrug
Also called Pegasys
Peginterferon alfa-2a 180ug per week
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator:NAs group | Active comparator | Active Comparator:nucleotide analogues(NAs)
patients continue to use NAs Receives: Drug: Nucleotide Analog |
| Experimental:PEG-IFN group | Experimental | Experimental: peg-interferon alfa-2a
patients use peg-interferon α-2a and nucleotide analogues(NAs) Receives: Drug: Nucleotide Analog; Drug: Interferon Alfa-2A |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBsAg clearance rate
Whether the HBsAg clearance rate of patients who received interferon treatment was higher than those treated with nucleoside drugs.
Measured: 48 weeks
Secondary outcomes (1)
HBV cccDNA and pgRNA quantification dynamic change
The difference in cccDNA and pgRNA clearance rate between the two groups after 48 weeks of treatment in immune-controlled patients.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start1 Dec 2018
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2024 (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 Hepatitis BStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Parallel groups
- Model description
- Drug: nucleotide analogues(NAs) Drug: Peginterferon alfa-2a and nucleotide analogues(NAs)
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- First People's Hospital of Foshan, Eighth Affiliated Hospital, Sun Yat-sen University
- Responsible party
- Principal investigator, Chan Xie, Sun Yat-sen University
- Investigators
- Chan Xie, Principal investigator, The Third Affliated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771677
- Sponsor's protocol ID
- XC1
- Acronym
- IFNA2/ISGs
- Status last verified
- May 2023
- First submitted
- 8 Dec 2018
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen X, Zhang B, Song X, Qian T, Zheng X, Zhang Y, Xu W, Gao Z, Peng L, Xie C. Serum sPD-1 and sPD-L1 as predictive biomarkers for HBsAg clearance in HBeAg-negative CHB patients undergoing IFN-based therapy. Aliment Pharmacol Ther. 2024 Sep;60(5):593-603. doi: 10.1111/apt.18131. Epub 2024 Jun 25.
PubMed 38923559
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Controlled Study to Optimize the Therapeutic Pathway of Peginterferon Alfa-2b Treatment in Patients With Chronic Hepatitis B Based on IFNA2p.Ala120Thr /ISGs Gene Spectrum.
- ClinicalTrials.gov ID
- NCT03771677
- Acronym / sponsor ID
- IFNA2/ISGs / XC1
- Conditions
- Hepatitis B
- Keywords
- Chronic Hepatitis B, IFNA2p.Ala120Thr /ISGs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- First People's Hospital of Foshan, Eighth Affiliated Hospital, Sun Yat-sen University
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 11 Dec 2018 (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 study is to guide clinical cure of peginterferon alfa-2a treatment in patients with chronic hepatitis B based on the detection of interferon gene mutation (IFNA2p.Ala120Thr) and interferon-stimulated genes (ISGs) detection gene spectrum.
Detailed description
It is estimated that more than 400 million people are infected with hepatitis B virus (HBV) globally.How to make more patients with chronic hepatitis B get clinical treatment through the existing anti-viral treatment is an urgent problem to be solved.This study is a random, multi-center and open experiment,the collaborators includes the second people's hospital of zhongshan city, the eighth people's hospital of guangzhou city, and the first people's hospital of foshan city.
Patients with chronic hepatitis B who were treated with NAs for over 1 year,HBsAg quantification≤1500 IU/mL, HBeAg negative and serum HBV DNA quantification <100 IU/mL were enrolled in this study. In our study, the enrolled patient's IFNA2p.Ala120Thr without variation and ISGs>0.05 were divided into two groups. After informed consent , patients were grouped according to their treatment intentions,in one group, patients continued NAs for another 48 weeks. In another group , patients were treated with peg-interferon-2a and NAs for 48 weeks.Patient's BMI, genotype, family history, smoking history, drinking history, other medical history, suspected transmission channels, types and time of use were recorded in this study.Moreover, Patients were assessed every 12 weeks,included liver and kidney function, blood routine, HBV cccDNA, HBeAg quantification, HBsAg quantification, pgRNA and so on.In addition,liver imaging examination and liver hardness test were assessed every six months.
In this study, we will analyze whether clinical cure rates differed between patients with chronic hepatitis B treated with peginterferon alfa-2a and NAs;Bisedes,the baseline interferon variant site variants and changes in interferon-stimulated gene profile expression were analyzed to determine whether they could be used as molecular markers to predict clinical cure with interferon.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Drug: nucleotide analogues(NAs) Drug: Peginterferon alfa-2a and nucleotide analogues(NAs)
| Arm | Type | Receives |
|---|---|---|
| Active Comparator:NAs group | Active comparator | Drug: Nucleotide AnalogActive Comparator:nucleotide analogues(NAs) patients continue to use NAs |
| Experimental:PEG-IFN group | Experimental | Drug: Nucleotide Analog, Drug: Interferon Alfa-2AExperimental: peg-interferon alfa-2a patients use peg-interferon α-2a and nucleotide analogues(NAs) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 60 years old;
- HBsAg positive, HBsAg quantification≤1500 IU/mL;
- Serum HBV DNA quantification <100 IU/mL;
- HBeAg negative.
Key exclusion criteria (9 listed)
- Treated with interferon in the past six months;
- Liver cirrhosis or HCC and other associated tumors;
- Women during pregnancy or lactation;
- With liver disease caused by other causes;
- Combination infection of HIV or other immunodeficiency diseases;
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 |
|---|---|---|
| Nucleotide AnalogAlso: Nucleotide Analogssuch as Entecavir,entecavir 0.5mg per day | Drug | Active Comparator:NAs group, Experimental:PEG-IFN group |
| Interferon Alfa-2AAlso: PegasysPeginterferon alfa-2a 180ug per week | Drug | Experimental:PEG-IFN group |
Primary outcome
HBsAg clearance rate
Time frame: 48 weeks
Whether the HBsAg clearance rate of patients who received interferon treatment was higher than those treated with nucleoside drugs.
1 secondary outcome
HBV cccDNA and pgRNA quantification dynamic change
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- Derived from this study: PubMed 38923559Chen X, Zhang B, Song X, Qian T, Zheng X, Zhang Y, Xu W, Gao Z, Peng L, Xie C. Serum sPD-1 and sPD-L1 as predictive biomarkers for HBsAg clearance in HBeAg-negative CHB patients undergoing IFN-based therapy. Aliment Pharmacol Ther. 2024 Sep;60(5):593-603. doi: 10.1111/apt.18131. Epub 2024 Jun 25.
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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.
Chan Xie principal investigator
The Third Affliated Hospital of Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nucleotide Analog and Interferon Alfa-2A in people with Hepatitis B, run by Sun Yat-sen University 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 4 inclusion and 9 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 8 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chan Xie, Professor (862085252043, happyxiechan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBsAg clearance rate (time frame: 48 weeks). 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 NCT03771677, 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 8 May 2023.