Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B (Chinese PAC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00781105
First received: October 27, 2008
Last updated: May 3, 2012
Last verified: May 2012

October 27, 2008
May 3, 2012
August 2008
September 2010   (final data collection date for primary outcome measure)
HBV DNA PCR negativity rate [ Time Frame: at 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00781105 on ClinicalTrials.gov Archive Site
  • HBV DNA PCR negativity rate [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • DNA reduction [ Time Frame: from baseline to Weeks 12, 24, 36, 52 ] [ Designated as safety issue: No ]
  • HBeAg loss rate [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
  • HBeAg seroconversion rate [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
  • ALT normalization rate [ Time Frame: at weeks 24 and 52 ] [ Designated as safety issue: No ]
  • Incidence of AE (SAE,etc), Graded lab abnormalities [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B
An Open-label, Multicenter, Phase IV Study to Evaluate the Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B

The "Chinese PAC" study (CLDT600ACN03) will evaluate the efficacy and safety of open label telbivudine in 2,200 compensated Chronic Hepatitis B (CHB) adults. The primary objective of the study is the proportion of patients achieving undetectable HBV DNA at week 52.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis B
Drug: Telbivudine
600 mg/day, oral tablets, once daily, 52 weeks
Experimental: 1
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.
 
Completed
2200
Not Provided
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female 16 to 65 year of age
  • Documented CHB defined by detectable serum HBsAg and serum HBV DNA level
  • Willing and able to comply with the study drug regimen
  • Written informed consent before any assessment

Exclusion Criteria:

  • Patient has a history of/or clinical signs/symptoms of hepatic decompensation
  • Patient has a history of HCC or findings suggestive of possible HCC
  • Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational at any time
  • History of hypersensitivity to any of the drugs (telbivudine) or to drugs of similar clinical classes
  • Patient has received IFN or other immunomodulatory treatment with 12 months before screening
  • Previous treatment history with NRTIs

Other protocol-defined inclusion/exclusion criteria may apply.

Both
16 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00781105
CLDT600ACN03
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Principal Investigator: Jia Jidong, Dr. Beijing Friendship Hospital
Novartis
May 2012

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