Effect of Serum Vitamin D Level on the Efficacy of Peg-interferon Treatment in CHB

Phase 4

Completed

• Conditions: Chronic Hepatitis b
• Interventions: Drug: Vitamin D

• Registration Number: NCT05753280
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary

In recent years, vitamin D (VD) has received much attention in the fields of host immune regulation, inflammation, fibrosis, cell proliferation and differentiation and tumor. VD works by binding to the vitamin D receptor (VDR). VDR is mainly distributed in giant cells, dendritic cells, T cells and lymphocytes. Four SNPs of VDRS have been most studied: TaqI (rs731236), FokI (rs10735810), ApaI (rs7975232), and BsmI (rs1544410). At present, more and more patients have been treated with oral nucleotide/nucleoside analogues (NAs) with direct antiviral drugs in China, and a large part of them show low expression of HBsAg. Clinical cure can be pursued for these patients, that is, HBsAg turns negative. A number of studies have been carried out at home and abroad.

In this study, We will recruit CHB patients with low HBsAg levels. They all will receive pegylated interferon treatment and were randomly assigned to a vitamin D treatment or a control group. A final assessment will be made to determine whether vitamin D levels would affect the clearance rate of HBsAg.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2023-02
• Study First Submitted: 2023-02-22
• Study First Submitted QC: 2023-03-02
• Last Update Submitted: 2023-03-02
• Study First Posted: 2023-03-03
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1.According with the diagnosis of chronic hepatitis B in the guideline of China in 2015 2.18-60 years old 3.More than 1 year history of nucleot(s)ide analogues therapy with HBsAg ≤1500 IU/ml, negative HBeAg and HBV DNA<100 IU/ml 4.No contraindications of interferon

Exclusion Criteria

1. Allergy to interferon
2. Alanine transaminase >10 times of upper limit of normal(ULN) or total bilirubin >2 times of ULN
3. existing or previous decompensated liver cirrhosis
4. White blood cells or Platelet below the lower limit of normal
5. existing severe organ injury
6. combined with autoimmune diseases, psychiatric diseases, diabetes or thyroidism
7. confirmed or suspected malignant tumors
8. before or after transplantation
9. using immunosuppressor
10. pregnant or having a planned parenthood in 2 years
11. alcohol or drug addicted
12. infected by HIV
13. any conditions that is unsuitable to interferon therapy according to the doctors' judgement

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment group	Vitamin D	pegylated interferon 180ug/week and oral vitamin D3 800IU/day for no longer than 48 weeks

Primary Outcome Measures

Name	Time	Method
hepatitis B surface antigen	up to 48 weeks	hepatitis B surface antigen should be tested by the reagents from Roche or Abbott, which is expressed by using IU/ml.

Secondary Outcome Measures

Name	Time	Method
hepatitis B surface antibody	every 12 weeks for up to 48 weeks	hepatitis B surface antigen should be tested by the reagents from Roche or Abbott, which is expressed by using IU/ml

Trial Locations

Locations (1)

Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China