NCT01456312

Brief Summary

Primary objective: Compare Pegasys RGT overall response rate (i.e., HBeAg seroconversion rate) with Pegasys mono historical response rate at week 72 (48 week treatment with 24 week follow up) Secondary objective :

  • The changes of HBsAg titer
  • The rate of combined HBeAg seroconversion and HBV DNA \< 300 copies/mL
  • The rate of serum HBV DNA \< 300 copies/mL ⅳ. The rate of ALT normalization
  • The rate of HBsAg loss ⅵ. The rate of serum HBV DNA \< 10,000 copies/mL

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
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2012

Longer than P75 for phase_4

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

October 15, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 20, 2011

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

October 31, 2012

Status Verified

October 1, 2012

Enrollment Period

3.4 years

First QC Date

October 15, 2011

Last Update Submit

October 29, 2012

Conditions

Hepatitis B, Chronic

Keywords

Peginterferon alfa 2aEntecavirResponse Guided TherapyChronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • HBeAg seroconversion

    24 weeks post treatment follow up

Secondary Outcomes (1)

  • The changes of HBsAg titer

    baseline and 24weeks post treatment follow up

Study Arms (3)

HBsAg quantification>20,000 IU/ml

SHAM COMPARATOR

stop peginterferon alfa 2a if patients reach HBsAg quantification\>20,000 Iu/ml at 12w

Drug: Peginterferon alfa-2a

HBsAg<=1500IU/ml

SHAM COMPARATOR

extend peginterferon alfa 2a until 48weeks

Drug: Peginterferon alfa-2a

HBsAg >1500 <=20,000 IU/ML

SHAM COMPARATOR

add Entecavir for 12w with peginterferon alfa 2a then, extend peginterferon alfa 2a until 48w

Drug: Peginterferon alfa-2aDrug: Entecavir

Interventions

Peginterferon alfa-2aDRUG

Duration and combination

Also known as: Pegasys
HBsAg >1500 <=20,000 IU/MLHBsAg quantification>20,000 IU/mlHBsAg<=1500IU/ml
EntecavirDRUG

combination

Also known as: Baraclude Tab
HBsAg >1500 <=20,000 IU/ML

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years
  • Positive HBsAg for more than 6 months, positive HBeAg, detectable HBV DNA(patients must have \> 100,000 copies/ml as measured by PCR) and anti-HBs negative
  • Elevated serum ALT \> 2ULN but ≤ 10 × ULN as determined by two abnormal values taken ≥ 14 days apart during the six months before the first dose of study drug with at least one of the determinations obtained ≤ 35 days prior to the first dose.

You may not qualify if:

  • Patients must not have received antiviral therapy for their chronic hepatitis B. Patients who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded. Exception: patients who have had less than 6 months treatment of NA(Nucleos(t)ide analog) and more than 1 year wash-out period for systemic antiviral therapy and negative results in the NA resistance test at baseline are not excluded.
  • Positive test at screening for HAV IgM Ab, HCV-RNA or HCV Ab, HDV Ab or HIV Ab.
  • Diagnosed hepatic cellular carcinoma
  • Any evidence of decompensated liver disease (Childs B-C)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shinchon Severance Hospital

Seoul, Seoul, 120742, South Korea

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon alfa-2aentecavir

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

Study Officials

  • Kwansik Lee, professor

    Gangnam Severance Hospital

    STUDY CHAIR

Central Study Contacts

Kwansik Lee, professor

CONTACT

+82 11 9636 9935leeks519@yuhs.ac

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 15, 2011

First Posted

October 20, 2011

Study Start

September 1, 2012

Primary Completion

February 1, 2016

Study Completion

August 1, 2016

Last Updated

October 31, 2012

Record last verified: 2012-10

Locations

KR(1)