Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by The Fifth People's Hospital of Suzhou.
Recruitment status was  Recruiting
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

June 23, 2011
June 23, 2011
May 2011
December 2012   (final data collection date for primary outcome measure)
Serum HBV DNA [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
serum HBV DNA negativity and decline from baseline at week 48
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Telbivudine on Liver Cirrhosis in Patients With Chronic Hepatitis B (CHB)
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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Liver Cirrhosis
  • Chronic Hepatitis B
Drug: telbivudine
telbivudine 600mg/d 96 weeks
Other Name: Sebivo
Experimental: telbivudine
Intervention: Drug: telbivudine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
China
 
NCT01380951
szwy20110610
No
Chuanwu Zhu, the Fifth People's Hospital of Suzhou
The Fifth People's Hospital of Suzhou
Not Provided
Principal Investigator: Chuanwu Zhu, Doctor The Fifth People's Hospital of Suzhou
The Fifth People's Hospital of Suzhou
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP