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Chronic Hepatitis BPhase 1/2CTHBVACADCHBNCT02615639

A Clinical Trial on Hepatitis B Vaccine Activated-Dendritic Cells Combined With Anti-HBV Drugs in CHB

A Phase 1/2 study testing HPDC-T cells & Entecavir, Entecavir and HPDC-T cells & IFN-a-2a in people with Chronic Hepatitis B, run by Third Affiliated Hospital, Sun Yat-Sen University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The anti-virus effects is not satisfying in some of Chronic Hepatitis B（CHB) patients who have been on anti-Hepatitis B Virus (HBV) drugs therapy. Dendritic cell (DC) is critical in Hepatitis B Virus (HBV) specific immunity in the process of producing HBV promoter specific cytotoxic T cells (CTLs) and specific T… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Hepatitis B
What is being tested?
HPDC-T cells & Entecavir, Entecavir and HPDC-T cells & IFN-a-2a
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
No sites listed yet
Study dates
Nov 2015to Nov 2018
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • chronic hepatitis B patients, aged 18~65，Chinese
  • have been on entecavir（ETV） or telbivudine（LDT） treatment for more than 1 year,and HBV DNA<100 IU/ml（Roche Cobas）;or have been on
  • have been on PEG-IFN treatment for more than 24 weeks,and 20 < HBV DNA < 20000 IU/ml（Roche Cobas）.
  • HBsAg 100~5000 IU/ml
  • HBeAg 10~500 COI

Who cannot join

  • 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 (including compensated and decompensated cirrhosis) and liver failure;
  • severe bacterial or fungal infections;
  • a history of diabetes or cardiac disease or hypertension or nephrosis;
  • pregnant women.

Trial locations and contacts

No sites are listed yet.

Yurong Gu, MD. contact

18588628204 ext. +86

guyr163@163.com

Yuehua Huang, MD.&PHD. contact

18922103516 ext. +86

huangyh53@mail.sysu.edu.cn

About this study

Official title: A Clinical Trial on Hepatitis B Vaccine Activated-Dendritic Cells Combined With Anti-HBV Drugs in Chronic Hepatitis B

The anti-virus effects is not satisfying in some of Chronic Hepatitis B（CHB) patients who have been on anti-Hepatitis B Virus (HBV) drugs therapy. Dendritic cell (DC) is critical in Hepatitis B Virus (HBV) specific immunity in the process of producing HBV promoter specific cytotoxic T cells (CTLs) and specific T helper cells (HTLs), however they are defective in CHB patients. Therefore, if it were going to remove HBV completely, it mainly depends if the body itself can produce enough HBV specific cytotoxic T cells (CTLs) and specific T helper cells (HTLs). Our research is to plus Hepatitis B Vaccine Activated-DCs therapy to CHB patients who have been on anti-HBV drugs but with poor effects, supposing to significantly improve anti-HBV efficacy, even to clean HBV from the patients.

Read the detailed description

Patients who have been on anti-HBV therapy Complying with the inclusion criteria will be enrolled into our research, Nucleoside analogues (NAs,entecavir） treatment for more than 1 year or interferon（IFN)-a-2a (IFN-a-2a,Pegasys） treatment for more than 24 weeks. The patients will be randomly assigned to experimental group and control group with the ratio of 2:1, one group (control group) will go on receive the anti-HBV drugs treatment solely; another group (experimental group) after enrollment will immediately receive the Hepatitis B Vaccine activated-DCs (HPDC-T cells) for 24 weeks (every 2 weeks once for 24 weeks, 12 times in total), at the same time co-use anti-HBV drugs treatment, as for Pegasys, it will go on to be used for 12 weeks after HPDC-T cells treatment completed.

The technical route of HBV-T cells prepared: First, investigators collect fresh blood of CHB, mononuclear cells were isolated, and induced to HBsAg pulsed DCs in Hepatitis B vaccine (Shenzhen kangtai, Shenzhen, China) and interleukin-4（IL-4)/granulocyte-macrophage colony-stimulating factor(GM-CSF） (Perprotech, New Jersey, USA) (7 days), then co-culture of DCs and Peripheral Blood Mononuclear Cell(PBMCs ）7days, obtain HBV specific T cells, return to the patient finally.

Being tested
HPDC-T cells & Entecavir, Entecavir, HPDC-T cells & IFN-a-2a, IFN-a-2a, HPDC-T cells & Telbivudine
Keywords
HPDC-T cells, CHB, immuno therapy
Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HPDC-T cells & EntecavirBiological

    Also called Hepatitis B Vaccine Activated-DCs & Entecavir

    experimental groups will be given HPDC-T cells \& Entecavir. HPDC-T cells will be given for 24weeks on the basis of anti-HBV therapy ,and entecavir 0.5mg tablet every night by mouth

  • EntecavirDrug

    Also called Baraclude

    0.5mg tablet every night by mouth

  • HPDC-T cells & IFN-a-2aDrug

    Also called Hepatitis B Vaccine Activated-DCs & Pegasys

    experimental groups will be given HPDC-T cells \& IFN-a-2a. HPDC-T cells will be given for 24 weeks on the basis of anti-HBV therapy ,and IFN-a-2a 180ug subcutaneous injection every week

  • IFN-a-2aDrug

    Also called Pegasys

    IFN-a-2a 180ug subcutaneous injection every week

  • HPDC-T cells & TelbivudineDrug

    Also called Hepatitis B Vaccine Activated-DCs & Telbivudine

    experimental groups will be given HPDC-T cells \& Telbivudine. HPDC-T cells will be given for 24weeks on the basis of anti-HBV therapy ,and Telbivudine 600mg tablet every day by mouth

  • TelbivudineDrug

    Also called LDT

    Telbivudine 600mg tablet every day by mouth

Study groups in NCT02615639
Study groupRoleWhat they receive
HPDC-T cells & entecavirExperimentalHPDC-T cells 1-5×10^5 intravenous injection, every 2 weeks for 24 weeks , and entecavir(ETV) 0.5mg tablet by mouth, every night.
Receives: Biological: HPDC-T cells & Entecavir
entecavirActive comparatorentecavir 0.5mg tablet by mouth, every night.
Receives: Drug: Entecavir
HPDC-T cells & IFN-a-2aExperimentalHPDC-T cells 1-5×10^5 intravenous injection, every 2 weeks for 24 weeks ,and IFN-a-2a 180ug subcutaneous injection， every week for 9 months.
Receives: Drug: HPDC-T cells & IFN-a-2a
IFN-a-2aActive comparatorIFN-a-2a 180ug subcutaneous injection， every week for 9 months.
Receives: Drug: IFN-a-2a
HPDC-T cells & TelbivudineExperimentalHPDC-T cells 1-5×10^5 intravenous injection, every 2 weeks for 24 weeks ,and Telbivudine 600mg tablet by mouth, every night.
Receives: Drug: HPDC-T cells & Telbivudine
TelbivudineActive comparatorTelbivudine 600mg tablet by mouth, every night.
Receives: Drug: Telbivudine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hepatitis B surface Antigen （HBeAg）seroconversion

    to increase Hepatitis B surface antigen (HBsAg) loss rate from 1% up to 11% or more

    Measured: 3 years

Secondary outcomes (4)

  1. Number of participants with treatment-related adverse events as assessed by low-grade fever, Infection and shock.

    Safety profiles include side effects of anti-HBV drugs(ETV,LDT and IFN-a), viral resistance of anti-HBV drugs. And side effects of HPDC-T cells infusion,such as low-grade fever, Infection and shock.The difference of side effects rates between anti-HBV drugs monotherapy and anti-HBV drugs plus HPDC-T cells combined therapy will also be analyzed.

    Measured: one and a half year

  2. Hepatitis B envelope Antigen （HBeAg） seroconversion

    to increase HBeAg negative rate by 12 percentage points on the basis of the existing data

    Measured: 3 years

  3. HBV DNA clearance

    to increase the undetectable rate of HBV DNA

    Measured: 3 years

  4. ALT recovery

    to increase the recovery rate of ALT

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionNov 2018 (estimated)
  4. Study completionNov 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02615639
Sponsor's protocol ID
SunYatSenIDD
Acronym
CTHBVACADCHB
Status last verified
Nov 2015
First submitted
12 Nov 2015
Last updated
26 Nov 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Luo J, Li J, Chen RL, Nie L, Huang J, Liu ZW, Luo L, Yan XJ. Autologus dendritic cell vaccine for chronic hepatitis B carriers: a pilot, open label, clinical trial in human volunteers. Vaccine. 2010 Mar 16;28(13):2497-504. doi: 10.1016/j.vaccine.2010.01.038. Epub 2010 Jan 29.

    PubMed 20117267

  • Akbar SM, Furukawa S, Horiike N, Abe M, Hiasa Y, Onji M. Safety and immunogenicity of hepatitis B surface antigen-pulsed dendritic cells in patients with chronic hepatitis B. J Viral Hepat. 2011 Jun;18(6):408-14. doi: 10.1111/j.1365-2893.2010.01320.x.

    PubMed 20487261

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HPDC-T cells & Entecavir, Entecavir and HPDC-T cells & IFN-a-2a in people with Chronic Hepatitis B, run by Third Affiliated Hospital, Sun Yat-Sen University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yurong Gu, MD. (18588628204 ext. +86, guyr163@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hepatitis B surface Antigen （HBeAg）seroconversion (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02615639, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2015.

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