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Study of Therapeutic Vaccination With Intensified Schedule Plus Pegasys Dual Therapy on Chronic Hepatitis B Infection (E+VIP)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02097004
First Posted: March 26, 2014
Last Update Posted: May 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yoon Jun Kim, Seoul National University Hospital
  Purpose
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

Condition Intervention Phase
Hepatitis B, Chronic Biological: Peginterferon alfa-2a Biological: HBV vaccination Drug: Entecavir Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Yoon Jun Kim, Seoul National University Hospital:

Primary Outcome Measures:
  • The rate of HBsAg-seroclearance [ Time Frame: The rate of HBsAg-seroclearance at the time point of at weeks 100 ]
    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.


Secondary Outcome Measures:
  • The rate of HBsAg-seroconversion [ Time Frame: The rate of HBsAg-seroconversion at weeks 100 ]
    The rate of HBsAg-seroconversion at weeks 100 in the sequential treatment group versus control group(ETV monotherapy) at weeks 100.

  • The change of HBsAg level from baseline [ Time Frame: The change of HBsAg level from baseline at weeks 100 ]
    The change of HBsAg level from baseline at weeks 100 in the sequential treatment group versus control group(ETV monotherapy) at weeks 100.

  • The change of HBsAg-seroclearance [ Time Frame: 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 ]
    The change of HBsAg-seroclearance in the concomitant treatment group versus control group(ETV monotherapy) for exploratory assessment.

  • The change of HBsAg-seroconversion [ Time Frame: 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 ]
    The change of HBsAg-seroconversion in the concomitant treatment group versus control group(ETV monotherapy) for exploratory assessment.

  • The change of HBsAg level [ Time Frame: 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 ]
    The change of HBsAg level in the concomitant treatment group versus control group(ETV monotherapy) for exploratory assessment.


Enrollment: 111
Study Start Date: April 2014
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Concomitant:Pegasys, Euvax B, Baracrude
  • 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)
Biological: Peginterferon alfa-2a
once weekly 180 μg subcutaneous injection for 48 weeks
Other Name: Pegasys
Biological: HBV vaccination
1.0 mL (20 μg) intramuscular injection at 4, 8, 12 and 28 weeks
Other Name: Euvax B Inj
Drug: Entecavir
Continue Entecavir(0.5mg) for 100 weeks
Other Name: Baracrude
Experimental: Sequential:Pegasys, Euvax B, Baracrude
  • 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)
Biological: Peginterferon alfa-2a
once weekly 180 μg subcutaneous injection for 48 weeks
Other Name: Pegasys
Biological: HBV vaccination
1.0 mL (20 μg) intramuscular injection at 4, 8, 12 and 28 weeks
Other Name: Euvax B Inj
Drug: Entecavir
Continue Entecavir(0.5mg) for 100 weeks
Other Name: Baracrude
Active Comparator: Control Group
  • Continue Entecavir(0.5mg) for 100 weeks(once daily)
  • After EOS(100W), injection(once weekly) a Peginterferon alfa-2a for 48 weeks
Biological: Peginterferon alfa-2a
once weekly 180 μg subcutaneous injection for 48 weeks
Other Name: Pegasys
Drug: Entecavir
Continue Entecavir(0.5mg) for 100 weeks
Other Name: Baracrude

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)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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)

  2. Patients who have evidence of renal insufficiency defined as serum creatinine>1.5 mg/dL
  3. Patients with psychological problem including depression
  4. 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)
  5. Patients with seropositivity for anti-HCV, anti-HDV or anti-HIV
  6. Patients who have excessive alcohol consumption (> 30 g/day)
  7. Patients who have evidence of autoimmune hepatitis, hemochromatosis or Wilson's disease
  8. Pregnant or breast feeding females or plan for pregnancy or no contraception
  9. Patients with disease may deteriorate with interferon therapy(eg, autoimmune thyroiditis)
  10. Patients who have an psoriasis
  11. Patients who have history of antiviral-resistant HBV after previous treatment with oral antiviral agents
  12. Previous diagnosis with immunodeficiency or concomitant treatment of immune suppressive agent or previous organ transplantation Recipients
  13. Patients who have a history of hypersensitivity to study drug
  14. Uncontrollable seizure, convulsion and/or central nervous system disorders
  15. Patients with severe bone marrow disorder or with history of hypersensitivity to biologic agent such as vaccine.
  16. Neutrophil count < 1,500/mm3 or platelet count < 75,000/mm3 or hemoglobin < 10 g/dl
  17. Patients with Pulmonary disease (in case of history of pulmonary disease with complete recovery, enrollment is on investigator's discretion)
  18. Patients who have a fever ≥ 38 °C at the baseline
  19. Patients who have a risk of febrile response or systemic reaction
  20. Patients who the investigator deems inappropriate to participate in this study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097004


Locations
Korea, Republic of
Seoul National University
Seoul, Korea, Republic of, ASI|KR|KS013
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Yoon Jun Kim, MD, PhD Seoul National University Hospital
  More Information

Responsible Party: Yoon Jun Kim, MD, PhD, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02097004     History of Changes
Other Study ID Numbers: E+VIP
First Submitted: March 23, 2014
First Posted: March 26, 2014
Last Update Posted: May 9, 2017
Last Verified: May 2017

Keywords provided by Yoon Jun Kim, Seoul National University Hospital:
chronic hepatitis B
Pegasys
Euvax B
Baracrude

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Vaccines
Interferon-alpha
Peginterferon alfa-2a
Entecavir
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents