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

Primary Purpose

Liver Cirrhosis, Chronic Hepatitis B

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
telbivudine
Sponsored by
The Fifth People's Hospital of Suzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring liver cirrhosis, chronic hepatitis B, antiviral therapy, telbivudine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • the Fifth People's Hospital of SuzhouRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

telbivudine

Arm Description

Outcomes

Primary Outcome Measures

Serum HBV DNA
serum HBV DNA negativity and decline from baseline at week 48

Secondary Outcome Measures

Serum HBeAg
rate of HBeAg seroconversion and HBeAg loss
Child-pugh score
the average decline of Child-pugh score at week 48 from baseline

Full Information

First Posted
June 23, 2011
Last Updated
June 23, 2011
Sponsor
The Fifth People's Hospital of Suzhou
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1. Study Identification

Unique Protocol Identification Number
NCT01380951
Brief Title
Safety and Efficacy of Telbivudine on Liver Cirrhosis in Patients With Chronic Hepatitis B (CHB)
Official Title
Clinical Study of Telbivudine on Liver Cirrhosis in Patients With Chronic Hepatitis B
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
The Fifth People's Hospital of Suzhou

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Chronic Hepatitis B
Keywords
liver cirrhosis, chronic hepatitis B, antiviral therapy, telbivudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
telbivudine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
telbivudine
Other Intervention Name(s)
Sebivo
Intervention Description
telbivudine 600mg/d 96 weeks
Primary Outcome Measure Information:
Title
Serum HBV DNA
Description
serum HBV DNA negativity and decline from baseline at week 48
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Serum HBeAg
Description
rate of HBeAg seroconversion and HBeAg loss
Time Frame
48 weeks
Title
Child-pugh score
Description
the average decline of Child-pugh score at week 48 from baseline
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chuanwu Zhu, Doctor
Organizational Affiliation
The Fifth People's Hospital of Suzhou
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Fifth People's Hospital of Suzhou
City
Suzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Honghao Zhang, B.A.
Email
zhanghonghao@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Chuanwu Zhu, Doctor

12. IPD Sharing Statement

Learn more about this trial

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

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