A Clinical Trial on HB-Vac Activated-DCs Combined With Peg-IFN or NAs in CHB
A Clinical Trial on Hepatitis B Vaccine Activated-DCs Combined With Peg-interferon or Nucleotide Analogs in Chronic Hepatitis B
1 other identifier
interventional
400
1 country
3
Brief Summary
The purpose of this study is to investigate whether HB-Vac Activated-DCs Combined With Peg-IFN or NAs has more efficacy than Peg-IFN or NAs alone in the treatment of chronic hepatitis B patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2015
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2013
CompletedFirst Posted
Study publicly available on registry
September 5, 2013
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedOctober 30, 2020
October 1, 2020
4.9 years
September 1, 2013
October 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HBV makers
HBV DNA loads,HBsAg/HBsAb titer,HBeAg/HBeAb titer
01/01/2014-31/12/2016, total 6 times (3 years)
Secondary Outcomes (5)
Coagulation tests
01/01/2014-31/12/2016, total 6 times (3 years)
liver function
01/01/2014-31/12/2016, total 6 times (3 years)
alpha-fetal protein
01/01/2014-31/12/2016, total 4 times (3 years)
B ultrasound or MRI examination of the liver
01/01/2014-31/12/2016, total 2 times (3 years)
Liver biopsy
01/01/2014-31/12/2016, total 2 times (3 years)
Study Arms (6)
HPDCs-T immune therapy combined with IFN
EXPERIMENTALHPDCs-T immune therapy:one time every 2 weeks during 12 weeks to 36 weeks, about 2\*105-1\*106 cells per time,total 12 times; IFN therapy (Peg-IFN α-2b/2a):one time every 1 week according to the standards for 48 weeks
HPDCs-T immune therapy combined with ETV
EXPERIMENTALHPDCs-T immune therapy:one time every 2 weeks during 12 weeks to 36 weeks, about 2\*105-1\*106 cells per time,total 12 times; Entecavir(ETV)therapy:0.5mg per day according guidelines for the treatment of chronic hepatitis B in the Asia Pacific Region
HPDCs-T immune therapy combined with LdT
EXPERIMENTALHPDCs-T immune therapy:one time every 2 weeks during 12 weeks to 36 weeks, about 2\*105-1\*106 cells per time,total 12 times; Telbivudine(LdT)therapy:600mg per day according guidelines for the treatment of chronic hepatitis B in the Asia Pacific Region
IFN treatment
NO INTERVENTIONIFN therapy (Peg-IFN α-2b/2a):one time every 1 week according to the standards for 48 weeks
ETV treatment
NO INTERVENTIONEntecavir(ETV)therapy:0.5mg per day according guidelines for the treatment of chronic hepatitis B in the Asia Pacific Region
LdT treatment
NO INTERVENTIONTelbivudine(LdT)therapy:600mg per day according guidelines for the treatment of chronic hepatitis B in the Asia Pacific Region
Interventions
HPDCs-T immune therapy:one time every 2 weeks during 12 weeks to 36 weeks, IV (in the vein), about 2\*105-1\*106 cells per time,total 12 times;
Eligibility Criteria
You may qualify if:
- serum hepatitis B surface antigen(HBsAg) positive for at least 6 months; HBV DNA loads≥ 104IU/ml(Roche Cobas); Containing the IFN treatment: 2ULN ≤ ALT ≤ 10ULN and TBil ≤ 2ULN; Containing the ETV/LdT treatment: 2ULN ≤ ALT and TBil ≤ 5ULN; All patients have not received antiviral treatment or immunotherapy for the last 6 months.
You may not qualify if:
- superinfection or co-infection with hepatitis A, C, D, E, cytomegalovirus and HIV, or Epstein-Barr virus; other liver diseases such as alcoholic liver disease, drug-induced hepatitis, Wilson disease and autoimmune hepatitis; ascites or gastrointestinal bleeding or peptic ulcer or esophageal varix by electronic gastroscope examination; liver cirrhosis; severe bacterial or fungal infections; a history of diabetes or cardiac disease or hypertension or nephrosis; pregnant women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Third Affiliated Hospital, Sun Yat-Sen Universitylead
- Ruijin Hospitalcollaborator
- Second People's Hospital of Yunnan Provincecollaborator
Study Sites (3)
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
The second people's hospital of yunnan province
Kunming, Yunnan, 650000, China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, 200000, China
Related Publications (1)
Gu Y, Gu L, Chen L, Li J, Liao C, Bi Y, Huang Z, Cai W, Wei J, Huang Y. Immunotherapy Using HBV Vaccine Pulsed DCs and Induced T-Cells Combined Antiviral Drugs in Treatment Naive CHB Patients-A Multi-Centre Phase II Study. J Viral Hepat. 2025 Feb;32(2):e14045. doi: 10.1111/jvh.14045.
PMID: 39815989DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yuehua Huang, Doctor
Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- director of liver disease laboratory
Study Record Dates
First Submitted
September 1, 2013
First Posted
September 5, 2013
Study Start
January 1, 2015
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
October 30, 2020
Record last verified: 2020-10