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HBsAg Related Response Guided Therapy

NCT ID: NCT01456312

Last Updated: 2012-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-08-31

Brief Summary

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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

Detailed Description

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After 12w treatment of Pegasys, depends on results of quantitative HBsAg test, Patients will be allocated to one of three groups.

* HBsAg \>20,000 : study termination
* Group A :1,500\<HBsAg≤ 20,000
* Group B : .HBsAg ≤ 1500 At week 48, according to HbeAg seroconversion, patients will be allocated to one of two sub-groups(A-1, A-2, B-1, B-2) Patients are seen for evaluation at treatment weeks 4,8,12,24,36,48. Post-treatment assessments will be performed at 4,12 and 24 week during off-treatment phase for the assessment of the primary and main secondary endpoints of the study.

Conditions

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Hepatitis B, Chronic

Keywords

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Peginterferon alfa 2a Entecavir Response Guided Therapy Chronic Hepatitis B

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HBsAg quantification>20,000 IU/ml

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

Group Type SHAM_COMPARATOR

Peginterferon alfa-2a

Intervention Type DRUG

Duration and combination

HBsAg<=1500IU/ml

extend peginterferon alfa 2a until 48weeks

Group Type SHAM_COMPARATOR

Peginterferon alfa-2a

Intervention Type DRUG

Duration and combination

HBsAg >1500 <=20,000 IU/ML

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

Group Type SHAM_COMPARATOR

Peginterferon alfa-2a

Intervention Type DRUG

Duration and combination

Entecavir

Intervention Type DRUG

combination

Interventions

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Peginterferon alfa-2a

Duration and combination

Intervention Type DRUG

Entecavir

combination

Intervention Type DRUG

Other Intervention Names

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Pegasys Baraclude Tab

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years
2. 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
3. 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.

Exclusion Criteria

1. 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.
2. Positive test at screening for HAV IgM Ab, HCV-RNA or HCV Ab, HDV Ab or HIV Ab.
3. Diagnosed hepatic cellular carcinoma
4. Any evidence of decompensated liver disease (Childs B-C)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kwan Sik Lee

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kwansik Lee, professor

Role: STUDY_CHAIR

Gangnam Severance Hospital

Locations

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Shinchon Severance Hospital

Seoul, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Kwansik Lee, professor

Role: CONTACT

Phone: +82 11 9636 9935

Email: [email protected]

Facility Contacts

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Sanghoon Ahn, professor

Role: primary

Other Identifiers

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ML25588

Identifier Type: -

Identifier Source: org_study_id