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

NCT05753280 | Completed Phase 4 DMC

• 1 other identifier: G58
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis b

Keywords

hepatitis B; Vitamin D; Interferon

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• hepatitis B surface antibody

  every 12 weeks for up to 48 weeks

Study Arms (2)

treatment group

EXPERIMENTAL

pegylated interferon 180ug/week and oral vitamin D3 800IU/day for no longer than 48 weeks

Drug: Vitamin D

control group

NO INTERVENTION

pegylated interferon 180ug/week for no longer than 48 weeks

Interventions

Vitamin D DRUG

Patients take 800 mg vitamin D capsules daily during the whole treatment period

treatment group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

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)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Zhiliang Gao, Doctor

  Third Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic leader of the infectious diseases department

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 3, 2023
• Study Start: December 1, 2018
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: March 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)