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

June 23, 2011 updated by: The Fifth People's Hospital of Suzhou

Clinical Study of Telbivudine on Liver Cirrhosis in Patients With Chronic Hepatitis B

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China
        • Recruiting
        • The Fifth People's Hospital of Suzhou
        • Contact:
        • Principal Investigator:
          • Chuanwu Zhu, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: telbivudine
Drug: telbivudine
telbivudine 600mg/d 96 weeks
Other Names:
  • Sebivo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum HBV DNA
Time Frame: 48 weeks
serum HBV DNA negativity and decline from baseline at week 48
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum HBeAg
Time Frame: 48 weeks
rate of HBeAg seroconversion and HBeAg loss
48 weeks
Child-pugh score
Time Frame: 48 weeks
the average decline of Child-pugh score at week 48 from baseline
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Fifth People's Hospital of Suzhou

Investigators

  • Principal Investigator: Chuanwu Zhu, Doctor, The Fifth People's Hospital of Suzhou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

June 23, 2011

First Submitted That Met QC Criteria

June 23, 2011

First Posted (Estimate)

June 27, 2011

Study Record Updates

Last Update Posted (Estimate)

June 27, 2011

Last Update Submitted That Met QC Criteria

June 23, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • szwy20110610

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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