Chronic Hepatitis bNCT06920329
Effects of Peginterferon Consolidation Therapy on Hepatic cccDNA Dynamics in CHB Patients Achieving Clinical Cure.
A study testing Peginterferon α-2b based injection in people with Chronic Hepatitis b, run by Xiamen Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
This is a single-center, prospective, exploratory clinical study. The study plans to enroll 30 chronic hepatitis B (CHB) patients which achieved HBsAg clearance based peginterferon α-2b treatment. 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 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2025to 31 Mar 2028
- 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
- Voluntarily enroll in the study, able to understand and voluntarily sign the informed consent form;
- Aged 18-65 years (inclusive), no gender restriction;
- A history of HBsAg positivity for at least 6 months or other evidence suggesting chronic hepatitis B;
- First observed clinical cure after treatment with peginterferon α-2b (PegIntron®), either as monotherapy or in combination with NAs, defined as serum HBsAg negative (<0.05IU/ml), HBV DNA undetectable (HBV DNA<20IU/ml), and HBeAg negative, within a 4-week window from the first observed day of clinical cure at the time of screening;
- Agreement to undergo two liver biopsies during the study;
- Negative pregnancy test within 24 hours before the first liver biopsy (for childbearing-age females); and subjects (both male and female) should use effective contraception during the study period.
Who cannot join
- Lactating women;
- Evidence of acute severe liver injury: such as ALT > 10 ULN, or significantly elevated ALT with significantly elevated bilirubin;
- Evidence of decompensated liver disease: such as ascites, esophageal varices rupture bleeding, sepsis, hepatic encephalopathy, hepatorenal syndrome, etc.; or history of decompensated cirrhosis;
- Evidence of hepatocellular carcinoma;
- Prothrombin time (PT) or INR > ULN;
- Participation in other interventional trial studies within 3 months before screening or other conditions deemed unsuitable for inclusion 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
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian
Huiqing, Ph.D
About this study
Official title: An Exploratory Clinical Study Evaluating the Impact of Interferon Consolidation Therapy on Intrahepatic cccDNA Levels in Chronic Hepatitis B Patients Who Achieved Clinical Cure With Peginterferon α-2b Therapy.
This is a single-center, prospective, exploratory clinical study. The study plans to enroll 30 chronic hepatitis B (CHB) patients which achieved HBsAg clearance based peginterferon α-2b treatment. Eligible subjects will receive either 12-24 weeks interferon consolidation therapy (180μg administered subcutaneously in the abdomen or thigh once weekly) or not according to physician's recommendation and patient's preference, with regular follow-up for HBV recurrence. Patients will be followed up every 12 weeks. The study will evaluate changes in intrahepatic covalently closed circular DNA (cccDNA) and peripheral blood HBV pregenomic RNA (pgRNA) levels after achieving HBsAg clearance.
- Conditions
- Chronic Hepatitis b
- Being tested
- Peginterferon α-2b based injection
- Keywords
- Peginterferon α-2b injection, cccDNA, pgRNA
- 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 injectionDrug
Peginterferon α-2b injection, 180 μg administered subcutaneously in the abdomen or thigh once weekly, with regular follow-up for HBV recurrence. Patients will be followed up every 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Peginterferon α-2b based group | Experimental | Not described Receives: Drug: Peginterferon α-2b based injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in intrahepatic cccDNA and peripheral blood pgRNA levels
Measured: baseline to week48
Clearance rate of intrahepatic cccDNA
Measured: week48
Secondary outcomes (9)
Correlation between changes in intrahepatic cccDNA levels and interferon consolidation therapy
Measured: baseline to week48
Correlation between changes in peripheral blood pgRNA levels and interferon consolidation therapy
Measured: baseline to week48
Correlation between intrahepatic cccDNA clearance and interferon consolidation therapy
Measured: week48
Changes in intrahepatic cccDNA levels
Measured: baseline to week48
Changes in intrahepatic HBsAg levels
Measured: baseline to week48
intrahepatic HBsAg clearance rate
Measured: baseline、week48
Histopathological scores in hepatic inflammation and fibrosis
Measured: baseline、week48
Recurrence rate
Measured: baseline to week48
Adverse Event#AE#
Measured: baseline to week48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start20 Apr 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiamen Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Huiqing, Xiamen Hospital of Traditional Chinese Medicine
- Investigators
- Huiqing Liang, Ph.D, Principal investigator, Xiamen Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920329
- Sponsor's protocol ID
- 2024K04701
- Status last verified
- Apr 2025
- First submitted
- 2 Apr 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study Evaluating the Impact of Interferon Consolidation Therapy on Intrahepatic cccDNA Levels in Chronic Hepatitis B Patients Who Achieved Clinical Cure With Peginterferon α-2b Therapy.
- ClinicalTrials.gov ID
- NCT06920329
- Acronym / sponsor ID
- 2024K04701
- Conditions
- Chronic Hepatitis b
- Keywords
- Peginterferon α-2b injection, cccDNA, pgRNA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xiamen Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 20 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 9 Apr 2025 (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.
This is a single-center, prospective, exploratory clinical study. The study plans to enroll 30 chronic hepatitis B (CHB) patients which achieved HBsAg clearance based peginterferon α-2b treatment. Eligible subjects will receive either 12-24 weeks interferon consolidation therapy (180μg administered subcutaneously in the abdomen or thigh once weekly) or not according to physician's recommendation and patient's preference, with regular follow-up for HBV recurrence. Patients will be followed up every 12 weeks. The study will evaluate changes in intrahepatic covalently closed circular DNA (cccDNA) and peripheral blood HBV pregenomic RNA (pgRNA) levels after achieving HBsAg clearance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peginterferon α-2b based group | Experimental | Drug: Peginterferon α-2b based injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntarily enroll in the study, able to understand and voluntarily sign the informed consent form;
- Aged 18-65 years (inclusive), no gender restriction;
- A history of HBsAg positivity for at least 6 months or other evidence suggesting chronic hepatitis B;
- First observed clinical cure after treatment with peginterferon α-2b (PegIntron®), either as monotherapy or in combination with NAs, defined as serum HBsAg negative (<0.05IU/ml), HBV DNA undetectable (HBV DNA<20IU/ml), and HBeAg negative, within a 4-week window from the first observed day of clinical cure at the time of screening;
- Agreement to undergo two liver biopsies during the study;
Key exclusion criteria (6 listed)
- Lactating women;
- Evidence of acute severe liver injury: such as ALT > 10 ULN, or significantly elevated ALT with significantly elevated bilirubin;
- Evidence of decompensated liver disease: such as ascites, esophageal varices rupture bleeding, sepsis, hepatic encephalopathy, hepatorenal syndrome, etc.; or history of decompensated cirrhosis;
- Evidence of hepatocellular carcinoma;
- Prothrombin time (PT) or INR > ULN;
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 injectionPeginterferon α-2b injection, 180 μg administered subcutaneously in the abdomen or thigh once weekly, with regular follow-up for HBV recurrence. Patients will be followed up every 12 weeks. | Drug | Peginterferon α-2b based group |
Primary outcome
Changes in intrahepatic cccDNA and peripheral blood pgRNA levels
Time frame: baseline to week48
Clearance rate of intrahepatic cccDNA
Time frame: week48
9 secondary outcomes
Correlation between changes in intrahepatic cccDNA levels and interferon consolidation therapy
Time frame: baseline to week48
Correlation between changes in peripheral blood pgRNA levels and interferon consolidation therapy
Time frame: baseline to week48
Correlation between intrahepatic cccDNA clearance and interferon consolidation therapy
Time frame: week48
Changes in intrahepatic cccDNA levels
Time frame: baseline to week48
Changes in intrahepatic HBsAg levels
Time frame: baseline to week48
intrahepatic HBsAg clearance rate
Time frame: baseline、week48
Histopathological scores in hepatic inflammation and fibrosis
Time frame: baseline、week48
Recurrence rate
Time frame: baseline to week48
Adverse Event#AE#
Time frame: baseline to week48
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 9 Apr 2025.
Related trials for Chronic Hepatitis b
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
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.
Huiqing Liang, Ph.D principal investigator
Xiamen Hospital of Traditional Chinese Medicine
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 injection in people with Chronic Hepatitis b, run by Xiamen Hospital of Traditional Chinese Medicine 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 6 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: opening soon, as of the sponsor's last update on 9 Apr 2025. 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?
Contact Huiqing Liang, Ph.D (13306051108, 13306051108@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in intrahepatic cccDNA and peripheral blood pgRNA levels (time frame: baseline to week48). The study lists 2 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 9 Apr 2025.