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A Study of Peginterferon Alfa-2a [PEGASYS] in Patients With Chronic Hepatitis B Who Are HBeAg Positive

NCT ID: NCT01086085

Last Updated: 2016-11-02

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

265 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-03-31

Brief Summary

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This open-label, multi-center study will evaluate the effect on the quantitative HBsAg reduction of peginterferon alfa-2a \[PEGASYS\] in patients with HBeAg positive chronic hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. After 24 weeks of treatment, rapid responders will receive another 24 weeks of treatment. After 24 weeks of treatment, slow responders will be randomized to another 24 or 72 weeks of PEGASYS monotherapy, or to 72 weeks PEGASYS plus 36 weeks adefovir (10 mg, po once daily, starting from week 29 of PEGASYS treatment). The anticipated time on study drug is \>2 years.

Detailed Description

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Conditions

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Hepatitis B, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

peginterferon alfa-2a [PEGASYS]

Intervention Type DRUG

Early responders: PEGASYS 180 mcg sc once weekly for 48 weeks

B

Group Type EXPERIMENTAL

peginterferon alfa-2a [PEGASYS]

Intervention Type DRUG

Non-early responders: PEGASYS 180 mcg sc once weekly for 48 weeks

C

Group Type EXPERIMENTAL

peginterferon alfa-2a [PEGASYS]

Intervention Type DRUG

Non-early responders: PEGASYS 180 mcg sc once weekly for 96 weeks

D

Group Type EXPERIMENTAL

Adefovir

Intervention Type DRUG

Adefovir 10 mg po once daily for 36 weeks

peginterferon alfa-2a [PEGASYS]

Intervention Type DRUG

Non-early responders: PEGASYS 180 mcg sc once weekly for 96 weeks

Interventions

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Adefovir

Adefovir 10 mg po once daily for 36 weeks

Intervention Type DRUG

peginterferon alfa-2a [PEGASYS]

Early responders: PEGASYS 180 mcg sc once weekly for 48 weeks

Intervention Type DRUG

peginterferon alfa-2a [PEGASYS]

Non-early responders: PEGASYS 180 mcg sc once weekly for 48 weeks

Intervention Type DRUG

peginterferon alfa-2a [PEGASYS]

Non-early responders: PEGASYS 180 mcg sc once weekly for 96 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients \>/=18 years of age
* HBeAg positive chronic hepatitis B
* Compensated liver disease

Exclusion Criteria

* Patients who had previously received treatment of drugs with activity against HBV within 6 months prior to study start
* Antiviral, anti-neoplastic or immunomodulatory treatment
* Co-infection with active hepatitis A, hepatitis C, hepatitis D, or HIV
* Evidence of decompensated liver disease
* Chronic liver disease other than viral hepatitis
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Major Science and Technology Special Project of China Eleventh Five-year

OTHER

Sponsor Role collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Beijing, , China

Site Status

Beijing, , China

Site Status

Beijing, , China

Site Status

Beijing, , China

Site Status

Changchun, , China

Site Status

Guangzhou, , China

Site Status

Shanghai, , China

Site Status

Shanghai, , China

Site Status

Shanghai, , China

Site Status

Wuhan, , China

Site Status

Xi'an, , China

Site Status

Countries

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China

References

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Sun J, Ma H, Xie Q, Xie Y, Sun Y, Wang H, Shi G, Wan M, Niu J, Ning Q, Yu Y, Zhou H, Cheng J, Kang W, Xie Y, Fan R, Wei L, Zhuang H, Jia J, Hou J. Response-guided peginterferon therapy in patients with HBeAg-positive chronic hepatitis B: A randomized controlled study. J Hepatol. 2016 Oct;65(4):674-682. doi: 10.1016/j.jhep.2016.05.024. Epub 2016 May 26.

Reference Type DERIVED
PMID: 27238752 (View on PubMed)

Other Identifiers

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ML22266

Identifier Type: -

Identifier Source: org_study_id