Inactive HBsAg Carriers (IHCs) Treated With Pegylated Interferon α2b Based Intervention Therapy

NCT05451420 | Completed

• 1 other identifier: HenanPPHGRK
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

A single center, randomized controlled trial design was used to select patients with chronic hepatitis B in the immune control period (HBsAg positive, HBeAg negative, normal ALT, HBsAg ≤ 1500iu/ml, HBV DNA ≤ 2000iu/ml) to enter the study, and to compare the feasibility, effectiveness and safety of pegylate combined with Granulocyte-macrophage colony stimulating factor, high-dose hepatitis B vaccine and pegylate monotherapy in the treatment of patients with chronic hepatitis B in the immune control period

Conditions

Chronic Hepatitis B

Keywords

inactive hepatitis B virus carriers; HBsAg clearance; peginterferon alpha 2b; Intervention treatment

Outcome Measures

Primary Outcomes (1)

• HBsAg clearance at the end of 68 weeks of treatment

  To determine the response rate will be evaluated by HBsAg loss defined as HBsAg level lower than 0.05 IU/ml after 48 week treatment, compared with control group.

  68 weeks of treatment

Secondary Outcomes (2)

• HBsAg level and the decreasing extent of HBsAg level

  baseline，12 weeks, 24 weeks, 44 weeks，56 weeks， 68weeks，80 weeks，92weeks of treatment

• HBsAg seroconversion rate

  68 weeks of treatment

Other Outcomes (1)

• HBsAg clearance and seroconversion rate of PEG IFN based immunoadjuvant combined therapy

  baseline，12 weeks, 24 weeks, 44 weeks，56 weeks， 68weeks，80 weeks，92weeks of treatment

Study Arms (2)

Group A

EXPERIMENTAL

PegIFN α- 2b monotherapy, 180 μg/ week, 68 weeks of treatment, 24 weeks of follow-up after drug withdrawal

Drug: PegIFN α- 2b

Group B

ACTIVE COMPARATOR

Patients had a lead-in period of 16 weeks before baseline, pegifn α- 2b single drug treatment for 24 weeks, 4 weeks after drug withdrawal, 16 weeks of introduction period, pegifn α- 2b was followed up for 24 weeks. The plan of the induction period is as follows: 1) from the first day of the induction period, GM-CSF is injected subcutaneously ® one hundred μg/ piece, produced by Xiamen Tebao Bioengineering Co., Ltd.), 100 μg/ day, 5 consecutive days, one cycle every 4 weeks, 4 consecutive cycles. 2) On the third day of the induction period, recombinant hepatitis B vaccine (Saccharomyces cerevisiae) (1.0ml/HBsAg 60 per dose) was injected subcutaneously μg. Shenzhen Kangtai Biological Products Co., Ltd.), 60 μ g. Once every 4 weeks for 4 consecutive cycles, the course of treatment was 68 weeks, and the patients were followed up for 24 weeks.

Drug: PegIFN α- 2b

Interventions

PegIFN α- 2b DRUG

Adjuvant immunotherapy with GM-CSF and Hepatitis B vaccine ；GM-CSF（100 μg/ piece, produced by Xiamen Tebao Bioengineering Co., Ltd）；Hepatitis B vaccine（Each 1.0ml/HBsAg60 μ g. Shenzhen Kangtai Biological Products Co., Ltd）

Also known as: pegbin ® 180μg，produced by Xiamen Tebao Bioengineering Co., Ltd.

Group A; Group B

Eligibility Criteria

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

You may qualify if:

• age 18 to 65 years;
• HBsAg seropositive status for more than 6 months prior to enrollment;
• never received treatment with any form of nucleos(t)ide analogues (NAs) or interferon before enrollment;
• Serum HBsAg ≤1500 IU/mL;
• HBeAg negative with or without HBeAb positive;
• Serum HBV DNA ≤2000IU/ml IU/mL;
• normal ALT levels;
• normal white blood cell and platelet counts;
• abdominal computed tomography or B-ultrasound showed no cirrhosis, splenomegaly or ascites.

You may not qualify if:

• Participants with other hepatotropic viruses or human immunodeficiency virus co-infection
• other chronic non-viral liver diseases or decompensated liver diseases
• tumours
• drug abuse
• severe psychiatric disease
• uncontrolled thyroid disease or diabetes
• pregnancy or lactation

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead
• Xiamen Amoytop Biotech Co., Ltd.: collaborator

Study Sites (1)

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

Location

Related Publications (1)

• Ning H, Li K, Peng Z, Jin H, Zhao H, Shang J. The efficacy and safety of pegylated interferon alpha-2b-based immunotherapy for inactive hepatitis B surface antigen carriers. Eur J Gastroenterol Hepatol. 2023 Oct 1;35(10):1216-1223. doi: 10.1097/MEG.0000000000002627. Epub 2023 Aug 14.

  PMID: 37577817 DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Long-Term Synaptic Depression

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

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jia Shang

  Henan Provincial People's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 11, 2022
• Study Start: December 1, 2017
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2021
• Last Updated: July 13, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: End of study
• Access Criteria: Editors and reviewers of contributing magazines

Locations

CN (1)