A clinical control study of HBeAg(+) chronic hepatitis B patients using HBV antigen specific DCs/T cells adoptive immunotherapy and entecavir

A clinical non randomized control study of HBeAg(+) chronic hepatitis B patients using HBV antigen specific DCs/T cells adoptive immunotherapy and entecavir

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-ONRC-14004393

Enrollment

Unknown

Registered

2014-03-14

Start date

2014-04-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic hepatitis B

Interventions

Treatment group 1:Entecvir 0.5mg po qd+ HBV antigen specific DCs/T c

treatment group 2:Entecvir 0.5mg po qd+ HBV antigen specific DCs cel

treatment group 3:HBV antigen specific DCs/T cells adoptive immunoth

treatment group 4:HBV antigen specific DCs cells adoptive immunother

control group:HBV antigen specific DCs cells adoptive immunother

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age: 18 to 60 years old; HBeAg positive ; HBV DNA=105copies / ml; ALT: normal or =10×ULN; Bilirubin=2×ULN; Without antiretroviral drugs and cells immunotherapy treatment within one year; ISC<50 (using Elispot method to detect the IFN? spot of peripheral blood PBMC); HLA-A2 positive.

Exclusion criteria

Exclusion criteria: Patients with cirrhosis; Use of interferon, immunomodulator, cell therapy or any nucleoside analog that is active against hepatitis virus within one year; patients with malignancles (including lymphoma); patients combined any other system (heart, brain, kidney, etc.) disease or in the acute phase; combined CMV or EBV or HIV or HCV or syphilis infection; Breastfeeding or pregnant women (or planning pregnancy within the next year); patients with autoimmune disease.

Design outcomes

Primary

Measure	Time frame
The serum levels of HBV DNA;The serum levels of HBsAg;The serum levels of HBeAg;The serum levels of HBeA;	—

Secondary

Measure	Time frame
Albumin;Alanine aminotransferase;Aspartate aminotransferase;Total bilirubi;	—

Contacts

Public ContactXingnan Pan

The 180th hospital of PLA

qz180pxn@yahoo.com.cn+86 0595-28919439

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026