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

Chronic Hepatitis B Clinical Trial

Official title:

The Efficacy and Safety of Inactive Hepatitis B Surface Antigen (HBsAg) Carriers (IHCs) Treated With Pegylated Interferon α2b Based Intervention Therapy(HBsAg Positive, HBeAg Negative, ALT Normal, HBsAg ≤ 1500IU/ml, HBV DNA ≤ 2000IU/ml)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05451420
• Other study ID #: HenanPPHGRK
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2022
• Source: Henan Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Explore the efficacy, safety and related influencing factors of intervention therapy based on PegIFN α- 2b in inactive hepatis B surface antigen (HBsAg) carriers (IHCs), and compare pegifn α- 2b combined with granulocyte macrophage stimulating factor (GM-CSF), high-dose hepatitis B vaccine and pegifn α- 2B feasibility, efficacy and safety of monotherapy for IHCs.The IHCs patients were randomly divided into two groups (group A: pegifn α- 2b single drug group, group B: pegifn α- 2b combined with GM-CSF and high-dose hepatitis B vaccine group). To start applying pegifn α- 2B was the baseline, treatment for 68 weeks, followed up for 24 weeks after drug withdrawal. Patients in group B used GM-CSF and vaccine introduction for 16 weeks before baseline.The HBsAg clearance rate and related influencing factors of the two groups at 68 weeks were analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• PegIFN a- 2b
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)

Locations

Country	Name	City	State
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Henan Provincial People's Hospital	Xiamen Amoytop Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HBsAg clearance and seroconversion rate of PEG IFN based immunoadjuvant combined therapy	To assessment the HBsAg clearance and seroconversion rate of immunoadjuvant combined therapy on 68 weeks' curative effect	baseline,12 weeks, 24 weeks, 44 weeks,56 weeks, 68weeks,80 weeks,92weeks of treatment
Primary	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	HBsAg level and the decreasing extent of HBsAg level	To assessment the decreasing level and difference of HBsAg levels in different treatment groups	baseline,12 weeks, 24 weeks, 44 weeks,56 weeks, 68weeks,80 weeks,92weeks of treatment
Secondary	HBsAg seroconversion rate	To assessment the HBsAg seroconversion rate in different treatment groups	68 weeks of treatment