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Hepatitis B, ChronicPhase 4E+VIPNCT02097004

Study of Therapeutic Vaccination With Intensified Schedule Plus Pegasys Dual Therapy on Chronic Hepatitis B Infection

A Phase 4 study testing Peginterferon alfa-2a, HBV vaccination and Entecavir in people with Hepatitis B, Chronic, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A randomized, Open label, Single center, Prospective study to compare efficacy and safety of Therapeutic Vaccination with Intensified schedule plus Pegylated Interferon dual Therapy on Seroclearance of Hepatitis B virus Surface Antigen in Patients with Complete Virological Response Induced by Entecavir Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
Peginterferon alfa-2a, HBV vaccination and Entecavir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
1 siteSouth Korea
Study dates
Apr 2014to 13 Mar 2018
Phase
Phase 4
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 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 20 and 75 year-old
  • HBsAg-positive for > 6 months apart (medical history can be alternative)
  • Currently being treated with entecavir 0.5 mg/day for more than 18 months
  • Undetectable HBV DNA in serum (<20IU/mL) and HBeAg-negative or positive for > 1year
  • HBsAg titer < 3,000 IU/mL
  • ALT<300 IU/L
  • Signed written informed consent after being instructed about the objective and procedure of the clinical study

Who cannot join

  • Patients with decompensated liver cirrhosis, any one of the following ① Serum bilirubin > 3 mg/dL
  • ② Prothrombin time > 6 seconds prolonged or INR >2.3
  • ③ Serum albumin < 2.8 g/dL
  • ④ History of ascites, variceal hemorrhage, or hepatic encephalopathy
  • ⑤ Child-Pugh score ≥7 (Child-Pugh class B or C)
  • Patients who have evidence of renal insufficiency defined as serum creatinine>1.5 mg/dL
Show all 24Show fewer
  • Patients with psychological problem including depression
  • Patients who have previous/current significant co-morbidities including congestive heart failure, chronic kidney disease, hematologic disease and malignancy including hepatocellular carcinoma(patients with malignancy cured 5 years before screening can be enrolled)
  • Patients with seropositivity for anti-HCV, anti-HDV or anti-HIV
  • Patients who have excessive alcohol consumption (> 30 g/day)
  • Patients who have evidence of autoimmune hepatitis, hemochromatosis or Wilson's disease
  • Pregnant or breast feeding females or plan for pregnancy or no contraception
  • Patients with disease may deteriorate with interferon therapy(eg, autoimmune thyroiditis)
  • Patients who have an psoriasis
  • Patients who have history of antiviral-resistant HBV after previous treatment with oral antiviral agents
  • Previous diagnosis with immunodeficiency or concomitant treatment of immune suppressive agent or previous organ transplantation Recipients
  • Patients who have a history of hypersensitivity to study drug
  • Uncontrollable seizure, convulsion and/or central nervous system disorders
  • Patients with severe bone marrow disorder or with history of hypersensitivity to biologic agent such as vaccine.
  • Neutrophil count < 1,500/mm3 or platelet count < 75,000/mm3 or hemoglobin < 10 g/dl
  • Patients with Pulmonary disease (in case of history of pulmonary disease with complete recovery, enrollment is on investigator's discretion)
  • Patients who have a fever ≥ 38 °C at the baseline
  • Patients who have a risk of febrile response or systemic reaction
  • Patients who the investigator deems inappropriate to participate in this study

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University

    Seoul, ASI|KR|KS013

Other trials in South Korea

About this study

Official title: Phase4, to Compare Efficacy and Safety of Therapeutic Vaccination With Intensified Schedule Plus Pegylated Interferon Dual Therapy on Seroclearance of HBS Antigen in Patients With Complete Virological Response Induced by Entecavir

A randomized, Open label, Single center, Prospective study to compare efficacy and safety of Therapeutic Vaccination with Intensified schedule plus Pegylated Interferon dual Therapy on Seroclearance of Hepatitis B virus Surface Antigen in Patients with Complete Virological Response Induced by Entecavir

Read the detailed description

A randomized, Open label, Single center, Prospective study to compare efficacy and safety of Therapeutic Vaccination with Intensified schedule plus Pegylated Interferon dual Therapy on Seroclearance of Hepatitis B virus Surface Antigen in Patients with Complete Virological Response Induced by Entecavir (E + VIP)

Being tested
Peginterferon alfa-2a, HBV vaccination, Entecavir
Keywords
chronic hepatitis B, Pegasys, Euvax B, Baracrude
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.

  • Peginterferon alfa-2aBiological

    Also called Pegasys

    once weekly 180 μg subcutaneous injection for 48 weeks

  • HBV vaccinationBiological

    Also called Euvax B Inj

    1.0 mL (20 μg) intramuscular injection at 4, 8, 12 and 28 weeks

  • EntecavirDrug

    Also called Baracrude

    Continue Entecavir(0.5mg) for 100 weeks

Study groups in NCT02097004
Study groupRoleWhat they receive
Concomitant:Pegasys, Euvax B, BaracrudeExperimental* Peginterferon alfa-2a: once weekly 180 μg subcutaneous injection for 48 weeks * HBV vaccination (Euvax B Inj): 1.0 mL (20 μg) intramuscular injection at 4, 8, 12 and 28 weeks * Continue Entecavir(0.5mg) for 100 weeks(once daily)
Receives: Biological: Peginterferon alfa-2a; Biological: HBV vaccination; Drug: Entecavir
Sequential:Pegasys, Euvax B, BaracrudeExperimental* Peginterferon alfa-2a: once weekly 180 μg or weight base dose subcutaneous injection for 48 weeks * HBV vaccination (Euvax B Inj): 1.0 mL (20 μg) intramuscular injection at 52, 56, 60 and 76 weeks * Continue Entecavir(0.5mg) for 100 weeks(once daily)
Receives: Biological: Peginterferon alfa-2a; Biological: HBV vaccination; Drug: Entecavir
Control GroupActive comparator* Continue Entecavir(0.5mg) for 100 weeks(once daily) * After EOS(100W), injection(once weekly) a Peginterferon alfa-2a for 48 weeks
Receives: Biological: Peginterferon alfa-2a; Drug: Entecavir

What is being measured

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

  1. The rate of HBsAg-seroclearance

    The rate of HBsAg-seroclearance at the time point of at weeks 100 in the sequential treatment group (24 weeks after termination of treatment) versus control group(ETV monotherapy) at weeks 100.

    Measured: The rate of HBsAg-seroclearance at the time point of at weeks 100

Secondary outcomes (5)

  1. The rate of HBsAg-seroconversion

    The rate of HBsAg-seroconversion at weeks 100 in the sequential treatment group versus control group(ETV monotherapy) at weeks 100.

    Measured: The rate of HBsAg-seroconversion at weeks 100

  2. The change of HBsAg level from baseline

    The change of HBsAg level from baseline at weeks 100 in the sequential treatment group versus control group(ETV monotherapy) at weeks 100.

    Measured: The change of HBsAg level from baseline at weeks 100

  3. The change of HBsAg-seroclearance

    The change of HBsAg-seroclearance in the concomitant treatment group versus control group(ETV monotherapy) for exploratory assessment.

    Measured: The change of HBsAg-seroclearance at weeks 4, weeks 12, weeks 24, weeks 36, weeks 48, weeks 60, weeks 72, weeks 96, weeks 100, weeks 148

  4. The change of HBsAg-seroconversion

    The change of HBsAg-seroconversion in the concomitant treatment group versus control group(ETV monotherapy) for exploratory assessment.

    Measured: The change of HBsAg-seroconversion at weeks 4, weeks 12, weeks 24, weeks 36, weeks 48, weeks 60, weeks 72, weeks 96, weeks 100, weeks 148

  5. The change of HBsAg level

    The change of HBsAg level in the concomitant treatment group versus control group(ETV monotherapy) for exploratory assessment.

    Measured: The change of HBsAg level at weeks 4, weeks 12, weeks 24, weeks 36, weeks 48, weeks 60, weeks 72, weeks 96, weeks 100, weeks 148

Timeline

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

  1. First posted26 Mar 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionJan 2018
  4. Study completion13 Mar 2018

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02097004
Sponsor's protocol ID
E+VIP
Acronym
E+VIP
Status last verified
May 2018
First submitted
23 Mar 2014
Last updated
9 May 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Lee JH, Lee YB, Cho EJ, Yu SJ, Yoon JH, Kim YJ. Entecavir Plus Pegylated Interferon and Sequential Hepatitis B Virus Vaccination Increases Hepatitis B Surface Antigen Seroclearance: A Randomized Controlled Proof-of-Concept Study. Clin Infect Dis. 2021 Nov 2;73(9):e3308-e3316. doi: 10.1093/cid/ciaa807.

    PubMed 32556157

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Peginterferon alfa-2a, HBV vaccination and Entecavir in people with Hepatitis B, Chronic, run by Seoul National University Hospital at 1 site in South Korea.

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 7 inclusion and 24 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: finished, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of HBsAg-seroclearance (time frame: The rate of HBsAg-seroclearance at the time point of at weeks 100). 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 NCT02097004, which also lists 1 linked publication.

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 9 May 2018.

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