NCT01769833

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2013

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

November 4, 2014

Status Verified

November 1, 2014

Enrollment Period

2 years

First QC Date

January 15, 2013

Last Update Submit

November 3, 2014

Conditions

Chronic Hepatitis B

Keywords

HBsAgChronic hepatitis BPEGinterferon Alfa-2A

Outcome Measures

Primary Outcomes (1)

  • Change in log10 HBsAg titer during antiviral therapy

    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.

    48 week

Secondary Outcomes (5)

  • HBV DNA undetectability and below 400 IU/mL during antiviral therapy and follow-up

    48 week, 96 week

  • HBeAg seroconversion and loss during antiviral therapy and at end of treatment and 1 and 2 years following end of treatment

    48 week, 96 week

  • HBsAg loss and HBsAg seroconversion at end of treatment and 1 and 2 years following end of treatment

    48 week, 96 week

  • Change in log10 HBsAg titer during follow-up

    48 week, 96 week

  • 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

    48 week

Other Outcomes (1)

  • effect of immune modulator therapy on the innate immune response in patients with HBeAg-positive CHB

    48 week, 96 week

Study Arms (2)

PEG-interferon-alfa 2A

ACTIVE COMPARATOR

PEG-interferon-alfa 2A

Drug: PEG-interferon-Alfa-2A

Nucleosides

PLACEBO COMPARATOR

Nucleosides

Drug: Nucleosides

Interventions

PEG-interferon-Alfa-2ADRUG

Pegasys ( PEG-interferon-Alfa-2A) 180mcg / subcutaneous / once-weekly

Also known as: Pegasys (PEG-interferon-Alfa-2A)
PEG-interferon-alfa 2A
NucleosidesDRUG
Nucleosides

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan National University Hospital

Busan, South Korea

Location

Related Publications (1)

  • Woo HY, Heo J, Tak WY, Lee HJ, Chung WJ, Park JG, Park SY, Park YJ, Lee YR, Hwang JS, Kweon YO. Effect of switching from nucleos(t)ide maintenance therapy to PegIFN alfa-2a in patients with HBeAg-positive chronic hepatitis B: A randomized trial. PLoS One. 2022 Jul 22;17(7):e0270716. doi: 10.1371/journal.pone.0270716. eCollection 2022.

    PMID: 35867702DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon alfa-2aNucleosides

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlycosidesCarbohydratesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Jeong Heo, Dr

    Pusan National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 17, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2016

Last Updated

November 4, 2014

Record last verified: 2014-11

Locations

KR(1)