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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by The Fifth People's Hospital of Suzhou.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01380951
First Posted: June 27, 2011
Last Update Posted: June 27, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The Fifth People's Hospital of Suzhou
  Purpose
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.

Condition Intervention Phase
Liver Cirrhosis Chronic Hepatitis B Drug: telbivudine Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Telbivudine on Liver Cirrhosis in Patients With Chronic Hepatitis B

Resource links provided by NLM:


Further study details as provided by The Fifth People's Hospital of Suzhou:

Primary Outcome Measures:
  • Serum HBV DNA [ Time Frame: 48 weeks ]
    serum HBV DNA negativity and decline from baseline at week 48


Secondary Outcome Measures:
  • Serum HBeAg [ Time Frame: 48 weeks ]
    rate of HBeAg seroconversion and HBeAg loss

  • Child-pugh score [ Time Frame: 48 weeks ]
    the average decline of Child-pugh score at week 48 from baseline


Estimated Enrollment: 120
Study Start Date: May 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: telbivudine Drug: telbivudine
telbivudine 600mg/d 96 weeks
Other Name: Sebivo

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01380951


Locations
China, Jiangsu
the Fifth People's Hospital of Suzhou Recruiting
Suzhou, Jiangsu, China
Contact: Honghao Zhang, B.A.       zhanghonghao@medmail.com.cn   
Principal Investigator: Chuanwu Zhu, Doctor         
Sponsors and Collaborators
The Fifth People's Hospital of Suzhou
Investigators
Principal Investigator: Chuanwu Zhu, Doctor The Fifth People's Hospital of Suzhou
  More Information

Responsible Party: Chuanwu Zhu, the Fifth People's Hospital of Suzhou
ClinicalTrials.gov Identifier: NCT01380951     History of Changes
Other Study ID Numbers: szwy20110610
First Submitted: June 23, 2011
First Posted: June 27, 2011
Last Update Posted: June 27, 2011
Last Verified: June 2011

Keywords provided by The Fifth People's Hospital of Suzhou:
liver cirrhosis
chronic hepatitis B
antiviral therapy
telbivudine

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Fibrosis
Liver Cirrhosis
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Pathologic Processes
Telbivudine
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action