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

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

Condition Intervention Phase
Chronic Hepatitis B
Drug: Telbivudine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter, Phase IV Study to Evaluate the Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • HBV DNA PCR negativity rate [ Time Frame: at 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2200
Study Start Date: August 2008
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Telbivudine
600 mg/day, oral tablets, once daily, 52 weeks


Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00781105

Novartis Investigative Site
Beijing, China
Sponsors and Collaborators
Novartis Pharmaceuticals
Principal Investigator: Jia Jidong, Dr. Beijing Friendship Hospital
  More Information

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00781105     History of Changes
Other Study ID Numbers: CLDT600ACN03 
Study First Received: October 27, 2008
Last Updated: May 3, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Novartis:
Chronic hepatitis B
HBV DNA suppression

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Anti-Infective Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 01, 2016