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

NCT06920329 | Not Yet Recruiting

• 1 other identifier: 2024K04701
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Peginterferon α-2b injection; cccDNA; pgRNA

Outcome Measures

Primary Outcomes (2)

• Changes in intrahepatic cccDNA and peripheral blood pgRNA levels

  baseline to week48

• Clearance rate of intrahepatic cccDNA

  week48

Secondary Outcomes (9)

• Correlation between changes in intrahepatic cccDNA levels and interferon consolidation therapy

  baseline to week48

• Correlation between changes in peripheral blood pgRNA levels and interferon consolidation therapy

  baseline to week48

• Correlation between intrahepatic cccDNA clearance and interferon consolidation therapy

  week48

• Changes in intrahepatic cccDNA levels

  baseline to week48

• Changes in intrahepatic HBsAg levels

  baseline to week48

Study Arms (1)

Peginterferon α-2b based group

EXPERIMENTAL

Drug: Peginterferon α-2b based injection

Interventions

Peginterferon α-2b based injection DRUG

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.

Peginterferon α-2b based group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Xiamen Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Xiamen Hospital of Traditional Chinese Medicine

Xiamen, Fujian, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Huiqing Liang, Ph.D

  Xiamen Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huiqing Liang, Ph.D

CONTACT

13306051108; 13306051108@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: April 20, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

CN (1)