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HBsAg Decline After Pegylated-interferon-α in e Antigen Positive Chronic Hepatitis B With Nucleoside Maintenance

This study is not yet open for participant recruitment.
Verified January 2013 by Pusan National University Hospital
Sponsor:
Information provided by (Responsible Party):
Pusan National University Hospital
ClinicalTrials.gov Identifier:
NCT01769833
First received: January 15, 2013
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

This study proposes to compare the effect of 48 weeks exposure to pegylated interferon alpha vs. nucleoside analogue (NA) on hepatitis B e antigen (HBeAg) seroconversion and HBsAg levels in nucleoside analogue controlled HBeAg-positive chronic hepatitis B (CHB) patients who have an undetectable hepatitis B virus (HBV) viral load at least 1 years.


Condition Intervention Phase
Chronic Hepatitis B
 Drug: PEG-interferon-Alfa-2A
Drug: Nucleosides
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HBsAg Decline and HBeAg Seroconversion Following 48 Weeks Peg-interferon-α Treatment in Patients With e Antigen Positive Chronic Hepatitis B After Nucleoside Analogue Maintenance Therapy Compared to Continuing Nucleoside Analogue Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pusan National University Hospital:

Primary Outcome Measures:
  • Change in log10 HBsAg titer during antiviral therapy [ Time Frame: 48 week ] [ Designated as safety issue: No ]
    To evaluate whether pegylated-IFNα2a treatment lowers HBsAg levels and eventually leads to HBsAg loss in patients after long term NA therapy compared to continuing NA treatment.


Secondary Outcome Measures:
  • HBV DNA undetectability and below 400 IU/mL during antiviral therapy and follow-up [ Time Frame: 48 week, 96 week ] [ Designated as safety issue: No ]
  • HBeAg seroconversion and loss during antiviral therapy and at end of treatment and 1 and 2 years following end of treatment [ Time Frame: 48 week, 96 week ] [ Designated as safety issue: No ]
  • HBsAg loss and HBsAg seroconversion at end of treatment and 1 and 2 years following end of treatment [ Time Frame: 48 week, 96 week ] [ Designated as safety issue: No ]
  • Change in log10 HBsAg titer during follow-up [ Time Frame: 48 week, 96 week ] [ Designated as safety issue: No ]
  • Mean change in log10 HBsAg titre over time, as estimated from the area between the baseline value and the curve of log10 HBsAg titre divided by the duration of treatment [ Time Frame: 48 week ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • effect of immune modulator therapy on the innate immune response in patients with HBeAg-positive CHB [ Time Frame: 48 week, 96 week ] [ Designated as safety issue: No ]
    To evaluate the effect of immune modulator therapy on the innate immune response in patients with HBeAg-positive CHB in whom NA treatment has resulted in undetectable viral replication.


Estimated Enrollment: 144
Study Start Date: May 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PEG-interferon-alfa 2A
PEG-interferon-alfa 2A
 Drug: PEG-interferon-Alfa-2A
Pegasys ( PEG-interferon-Alfa-2A) 180mcg / subcutaneous / once-weekly
Other Name: Pegasys (PEG-interferon-Alfa-2A)
Placebo Comparator: Nucleosides
Nucleosides
 Drug: Nucleosides

Detailed Description:

Pegylated interferon after long term NA therapy will potentiate the antiviral efficacy directly via its effect on broad antiviral activities and indirectly via activation of innate and adaptive immune responses leading to HBeAg seroconversion and eventually HBsAg loss and/or seroconversion.

This study proposes to compare the effect of 48 weeks exposure to pegylated interferon alpha vs. NA on HBeAg seroconversion and HBsAg levels in NA controlled HBeAg-positive CHB patients who have an undetectable HBV viral load at least 1 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent
  • Age over 20 years
  • HBeAg-positive CHB patients
  • Patients treated with all available nucleoside analogue monotherapy or combination in Korea except telbivudine ( e.g.entecavir monotherapy or lamivudine/adefovir combination , lamivudine, adefovir monotherapy) for ≥ 18months and patients who have undetectable HBV viral load at least one year HBV DNA undetectable (≤ 400 copies/ml ) Serum alanine transferase: ≤ 10 X upper limit of normal (ULN) Baseline HBsAg: ≥ 102 IU/ml
  • Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug. Additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during the study and for 3 months after treatment completion.
  • Obtaining written informed consent form

Exclusion Criteria:

  • Decompensated cirrhosis or other contraindications to interferon alfa 2a therapy following local label.
  • Concomitant or prior use of telbivudine.
  • Positive test at screening for hepatitis A virus immunoglobulin M Ab, Hepatitis C virus-RNA or hepatitis C virus Ab, hepatitis delta virus Ab or HIV Ab.
  • Diagnosed hepatic cellular carcinoma
  • Any evidence of decompensated liver disease (Childs B-C)
  • History or other evidence of a medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures, thalassemia).
  • Women with ongoing pregnancy or who are breast feeding.
  • Evidence of alcohol and/or drug abuse within one year of entry.
  • History of major organ transplantation with an existing functional graft.
  • Inability or unwillingness to provide informed consent or abide by the requirements of the study.
  • History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.
  • Patients with a value of alpha-fetoprotein >100 ng/mL are excluded, unless stability (less than 10% increase) has been documented over at least the previous 3 months.
  • patients having hypersensitivities for peginterferon alfa-2a or NAs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769833

Contacts
Contact: Jeong Heo, Dr + 82-51-240-7970 jheo@pusan.ac.kr

Locations
Korea, Republic of
Pusan National University Hospital Not yet recruiting
Busan, Korea, Republic of
Contact: Jeong Heo, Dr     + 82-51-240-7970     jheo@pusan.ac.kr    
Principal Investigator: Jeong Heo, Dr            
Sponsors and Collaborators
Pusan National University Hospital
Investigators
Principal Investigator: Jeong Heo, Dr Pusan National University Hospital
  More Information

No publications provided

Responsible Party: Pusan National University Hospital
ClinicalTrials.gov Identifier: NCT01769833     History of Changes
Other Study ID Numbers: ML25659
Study First Received: January 15, 2013
Last Updated: January 16, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Pusan National University Hospital:
HBsAg
Chronic hepatitis B
PEGinterferon Alfa-2A

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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
Interferon-alpha
 Interferon Alfa-2a
Interferons
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 16, 2013