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Efficacy and Safety of Peginterferon a-2a in Patients of Chronic Hepatitis B With Spontaneous Decline of HBV DNA

NCT ID: NCT01892241

Last Updated: 2013-10-01

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

PHASE3

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-02-28

Brief Summary

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Patients with spontaneous decline of HBV DNA were non-randomly assigned to accept peginterferon alfa-2a or entecavir therapy, or didn't accept any antiviral regiment.

Detailed Description

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It was a prospective, non-randomized, open-label study that evaluated the efficacy and safety of pegasys treatment in chronic hepatitis B patients with spontaneous HBVDNA decline after acute exacerbation.Patients with spontaneous decline of HBV DNA(a decrease of HBV DNA levels of more than 2 log(10) IU/mL as compared to baseline before antiviral treatment) after acute exacerbation (ALT was 10-30ULN，TBIL was 2-20mg/ml，PTA\>60%)were non-randomly divided into 3 groups: group A, B and C. Before treatment, the patients were counselled on the advantages and disadvantages of taking peginterferon or nucleos(t)ide analogue, and the subsequential treatment were decided by themselves. Cases in group A receive 180µg of peginterferon alfa-2a (Pegasys,Roche) once weekly for 48 weeks. Group B and C were control group, cases in group B received an continual entecavir therapy(0.5 mg orally once daily) and those in group C didn't accept any antiviral regiment.

Conditions

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Antiviral Treatment of Chronic Hepatitis B

Keywords

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Chronic hepatitis B,Spontaneous Decline of HBV DNA,Peginterferon a-2a, entecavir

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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180µg of peginterferon alfa-2a

Cases in group A receive 180µg of peginterferon alfa-2a (Pegasys,Roche) once weekly for 48 weeks.

Group Type EXPERIMENTAL

Pegasys(Roche)

Intervention Type DRUG

180µg of peginterferon alfa-2a (Pegasys,Roche) once weekly for 48 weeks.

Entecavir

cases in group B received an continual entecavir therapy(0.5 mg orally once daily)

Group Type ACTIVE_COMPARATOR

Entecavir

Intervention Type DRUG

continual entecavir therapy(0.5 mg orally once daily)

Control group

Those in group C didn't accept any antiviral regiment .

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pegasys(Roche)

180µg of peginterferon alfa-2a (Pegasys,Roche) once weekly for 48 weeks.

Intervention Type DRUG

Entecavir

continual entecavir therapy(0.5 mg orally once daily)

Intervention Type DRUG

Other Intervention Names

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peginterferon alfa-2a

Eligibility Criteria

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Inclusion Criteria

Patients with advanced fibrosis, cirrhosis and hepatoma were excluded. Other cause of chronic liver disease should be systematically checked to exclude co-infection with HDV, HCV and HIV, comorbidities with alcoholism, autoimmune and metabolic liver disease. Serious medical or psychiatric illnesses that had usage of corticosteroid or immunosup-pressive agents at the time of study were excluded. All patients in this study lived in Guangdong, a province of 100,000,000 populations, with same demographics. Owing to patients fear or refusal of liver biopsy, no patients had the liver biopsy and the rest relied on other clinical methods to obtain equivalent information of patient conditions. In our cases, ultrasonorgraphy helped to filter out patients with advanced fibrosis.The liver sonar examination was performed by two experi-enced hepatologists at least three times on each patient.
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Cai Qingxian

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gao Zhiliang, doctor

Role: STUDY_CHAIR

The Third Affliated Hospital of Sun Yat-sen University

Zhao Zhixin, doctor

Role: STUDY_DIRECTOR

The Third Affliated Hospital of Sun Yat-sen University

Other Identifiers

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ATFSHBVD

Identifier Type: -

Identifier Source: org_study_id