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

Chronic Hepatitis b Clinical Trial

Official title:

Effect of Serum Vitamin D Level and Vitamin D Receptor on the Efficacy of Pegylated Interferon in Patients With Chronic Hepatitis B With Low Level HBsAg Treated by Nucleos(t)Ide Analogues

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05753280
• Other study ID #: G58
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2023
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Vitamin D
Patients take 800 mg vitamin D capsules daily during the whole treatment period

Locations

Country	Name	City	State
China	Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hepatitis B surface antigen	hepatitis B surface antigen should be tested by the reagents from Roche or Abbott, which is expressed by using IU/ml.	up to 48 weeks
Secondary	hepatitis B surface antibody	hepatitis B surface antigen should be tested by the reagents from Roche or Abbott, which is expressed by using IU/ml	every 12 weeks for up to 48 weeks