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

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ClinicalTrials.gov Identifier: NCT00781105
Recruitment Status : Completed
First Posted : October 28, 2008
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE October 27, 2008
First Posted Date  ICMJE October 28, 2008
Last Update Posted Date February 23, 2017
Actual Study Start Date  ICMJE August 1, 2008
Actual Primary Completion Date September 16, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2008)
HBV DNA PCR negativity rate [ Time Frame: at 52 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2008)
  • HBV DNA PCR negativity rate [ Time Frame: at week 24 ]
  • DNA reduction [ Time Frame: from baseline to Weeks 12, 24, 36, 52 ]
  • HBeAg loss rate [ Time Frame: at week 52 ]
  • HBeAg seroconversion rate [ Time Frame: at week 52 ]
  • ALT normalization rate [ Time Frame: at weeks 24 and 52 ]
  • Incidence of AE (SAE,etc), Graded lab abnormalities [ Time Frame: at week 52 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B
Official Title  ICMJE An Open-label, Multicenter, Phase IV Study to Evaluate the Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis B
Intervention  ICMJE Drug: Telbivudine
600 mg/day, oral tablets, once daily, 52 weeks
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Telbivudine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 27, 2008)
2200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 16, 2010
Actual Primary Completion Date September 16, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00781105
Other Study ID Numbers  ICMJE CLDT600ACN03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jia Jidong, Dr. Beijing Friendship Hospital
PRS Account Novartis
Verification Date February 2017

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