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

This study is currently recruiting participants.
Verified June 2011 by The Fifth People's Hospital of Suzhou
Sponsor:
Information provided by:
The Fifth People's Hospital of Suzhou
ClinicalTrials.gov Identifier:
NCT01380951
First received: June 23, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Serum HBV DNA [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    serum HBV DNA negativity and decline from baseline at week 48


Secondary Outcome Measures:
  • Serum HBeAg [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    rate of HBeAg seroconversion and HBeAg loss

  • Child-pugh score [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Chuanwu Zhu, the Fifth People's Hospital of Suzhou
ClinicalTrials.gov Identifier: NCT01380951     History of Changes
Other Study ID Numbers: szwy20110610
Study First Received: June 23, 2011
Last Updated: June 23, 2011
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Liver Cirrhosis
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Fibrosis
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

ClinicalTrials.gov processed this record on June 18, 2013