Efficacy of Peg-interferon α-2a in Hepatitis B Patients Treated by Entecavir Without HBeAg Loss

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

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-04-30

Brief Summary

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For HBeAg (+) hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In the investigators study, patients were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.

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Detailed Description

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For HBeAg positive hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In our study, patients without HBeAg loss to 48 weeks entecavir treatment were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.

Conditions

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Hepatitis B

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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entecavir

patients continue to use entecavir

Group Type ACTIVE_COMPARATOR

Entecavir

Intervention Type DRUG

entecavir 0.5mg per day

peg-interferon

patients switch to sequential peg-interferon α-2a

Group Type EXPERIMENTAL

Peginterferon alfa-2a

Intervention Type DRUG

Peginterferon alfa-2a 180ug per week

Interventions

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Entecavir

entecavir 0.5mg per day

Intervention Type DRUG

Peginterferon alfa-2a

Peginterferon alfa-2a 180ug per week

Intervention Type DRUG

Other Intervention Names

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Baraclude Pagasys

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 50 years old
* HBsAg(+) and HBeAg(+) for over 6 months before entecavir treatment
* Treated by entacavir for 48 weeks with HBeAg seroconversion

Exclusion Criteria

* Pregnant women
* Decompensated liver disease
* Combination infection of HCV, HAV, or HEV
* Combination infection of HIV
* Any contraindication of interferon α

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No