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

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ClinicalTrials.gov Identifier: NCT01380951
Recruitment Status : Unknown
Verified June 2011 by The Fifth People's Hospital of Suzhou.
Recruitment status was:  Recruiting
First Posted : June 27, 2011
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:
The Fifth People's Hospital of Suzhou

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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Chronic Hepatitis B Drug: telbivudine Phase 4

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  (Clinical Trial)
Estimated Enrollment : 120 participants
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
Study Start Date : May 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Telbivudine

Arm Intervention/treatment
Experimental: telbivudine Drug: telbivudine
telbivudine 600mg/d 96 weeks
Other Name: Sebivo




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


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

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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

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

Responsible Party: Chuanwu Zhu, the Fifth People's Hospital of Suzhou
ClinicalTrials.gov Identifier: NCT01380951     History of Changes
Other Study ID Numbers: szwy20110610
First Posted: June 27, 2011    Key Record Dates
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