Clinical trial NCT05753280: Effect of Serum Vitamin D Level on the Efficacy of Peg-interferon Treatment in CHB
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis b
Keywords: hepatitis B
Vitamin D
Interferon
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: hepatitis B surface antigen
timeFrame: up to 48 weeks
Secondary outcomes:
measure: hepatitis B surface antibody
timeFrame: every 12 weeks for up to 48 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Zhiliang Gao, Doctor
role: STUDY_CHAIR
References: