Trial record 126 of 436 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Yoon Jun Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02097004
First received: March 23, 2014
Last updated: August 27, 2014
Last verified: August 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 72 ] [ Designated as safety issue: No ]
    The rate of HBsAg-seroclearance at the time point of at weeks 72 in the concomitant treatment group and at weeks 100 in the sequential treatment group (24 weeks after termination of treatment)


Secondary Outcome Measures:
  • The rate of HBsAg-seroconversion [ Time Frame: The rate of HBsAg-seroconversion at weeks 72 ] [ Designated as safety issue: No ]
    The rate of HBsAg-seroconversion at weeks 72 in theconcomitant treatment group and at weeks 100 in the sequential treatment group

  • The Change of HBsAg level from baseline [ Time Frame: The Change of HBsAg level from baseline at weeks 72 ] [ Designated as safety issue: No ]
    The Change of HBsAg level from baseline at weeks 72 in the concomitant treatment group and at weeks 100 in the sequential treatment group


Estimated Enrollment: 150
Study Start Date: April 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (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)
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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT02097004

Contacts
Contact: Yoon Jun Kim, MD. PhD 82-2-745-1721 yoonjun@snu.ac.kr
Contact: Yun Bin Lee yunbin@hanmail.net

Locations
Korea, Republic of
Seoul National University Recruiting
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

No publications provided

Responsible Party: Yoon Jun Kim, MD, PhD, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02097004     History of Changes
Other Study ID Numbers: E+VIP
Study First Received: March 23, 2014
Last Updated: August 27, 2014
Health Authority: Korea: Ministry of Food and Drug Safety

Keywords provided by Seoul National University Hospital:
chronic hepatitis B
Pegasys
Euvax B
Baracrude

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

ClinicalTrials.gov processed this record on September 16, 2014