Safety and Efficacy of Telbivudine on Liver Cirrhosis in Patients With Chronic Hepatitis B (CHB)

NCT ID: NCT01380951

Last Updated: 2011-06-27

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-12-31

Brief Summary

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Antiviral treatment on Chronic Hepatitis B (CHB) patients with liver cirrhosis is compulsory and effective. Telbivudine, which is superior to lamivudine in the treatment of CHB,is considered to be appropriate for the antiviral treatment on CHB patients with liver cirrhosis.

Detailed Description

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Antiviral therapy on CHB patients with liver cirrhosis is compulsory and effective. Diseases development can be prevented or delayed if the virus is depressed successfully. Lamivudine is often used and usually has good efficacy. However, lamivudine resistance and virus mutation happens a lot. Telbivudine, which is superior to lamivudine in the treatment of CHB,is considered to be appropriate for the antiviral treatment on CHB patients with liver cirrhosis.

Conditions

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Liver Cirrhosis Chronic Hepatitis B

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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telbivudine

Group Type EXPERIMENTAL

telbivudine

Intervention Type DRUG

telbivudine 600mg/d 96 weeks

Interventions

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telbivudine

telbivudine 600mg/d 96 weeks

Intervention Type DRUG

Other Intervention Names

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Sebivo

Eligibility Criteria

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Inclusion Criteria

* liver cirrhosis with CHB
* without history of antiviral therapy or discontinued antiviral therapy for more than 6 months
* for patients with compensated liver cirrhosis: HBV DNA≥4log copies/ml if HBeAg positive,HBV DNA≥3log copies/ml if HBeAg negative
* for patients with uncompensated liver cirrhosis:HBV DNA positive

Exclusion Criteria

* coinfection with HCV,HDV and HIV
* AFP≥100mg/L or HCC diagnosed by iconography
* with severe cardiovascular, respiratory and endocrinology diseases or autoimmune diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Fifth People's Hospital of Suzhou

OTHER

Sponsor Role lead

Responsible Party

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the Fifth People's Hospital of Suzhou

Principal Investigators

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Chuanwu Zhu, Doctor

Role: PRINCIPAL_INVESTIGATOR

The Fifth People's Hospital of Suzhou

Locations

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the Fifth People's Hospital of Suzhou

Suzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Honghao Zhang, B.A.

Role: primary

Other Identifiers

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szwy20110610

Identifier Type: -

Identifier Source: org_study_id

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