Effects of Peginterferon Consolidation Therapy on Hepatic cccDNA Dynamics in CHB Patients Achieving Clinical Cure.

April 2, 2025 updated by: Liang Huiqing, Xiamen Hospital of Traditional Chinese Medicine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China
        • Xiamen Hospital of Traditional Chinese Medicine
        • Contact:
          • Huiqing, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Peginterferon α-2b based group
Drug: Peginterferon α-2b based injection
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Changes in intrahepatic cccDNA and peripheral blood pgRNA levels
Time Frame: baseline to week48
baseline to week48
Clearance rate of intrahepatic cccDNA
Time Frame: week48
week48

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Correlation between changes in intrahepatic cccDNA levels and interferon consolidation therapy
Time Frame: baseline to week48
baseline to week48
Correlation between changes in peripheral blood pgRNA levels and interferon consolidation therapy
Time Frame: baseline to week48
baseline to week48
Correlation between intrahepatic cccDNA clearance and interferon consolidation therapy
Time Frame: week48
week48
Changes in intrahepatic cccDNA levels
Time Frame: baseline to week48
baseline to week48
Changes in intrahepatic HBsAg levels
Time Frame: baseline to week48
baseline to week48
intrahepatic HBsAg clearance rate
Time Frame: baseline、week48
baseline、week48
Histopathological scores in hepatic inflammation and fibrosis
Time Frame: baseline、week48
baseline、week48
Recurrence rate
Time Frame: baseline to week48
baseline to week48
Adverse Event#AE#
Time Frame: baseline to week48
baseline to week48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiamen Hospital of Traditional Chinese Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Huiqing Liang, Ph.D, Xiamen Hospital of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024K04701

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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