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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00781105
Recruitment Status : Completed
First Posted : October 28, 2008
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: Telbivudine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : August 1, 2008
Actual Primary Completion Date : September 16, 2010
Actual Study Completion Date : September 16, 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Telbivudine

Arm Intervention/treatment
Experimental: 1 Drug: Telbivudine
600 mg/day, oral tablets, once daily, 52 weeks

Primary Outcome Measures :
  1. HBV DNA PCR negativity rate [ Time Frame: at 52 weeks ]

Secondary Outcome Measures :
  1. HBV DNA PCR negativity rate [ Time Frame: at week 24 ]
  2. DNA reduction [ Time Frame: from baseline to Weeks 12, 24, 36, 52 ]
  3. HBeAg loss rate [ Time Frame: at week 52 ]
  4. HBeAg seroconversion rate [ Time Frame: at week 52 ]
  5. ALT normalization rate [ Time Frame: at weeks 24 and 52 ]
  6. Incidence of AE (SAE,etc), Graded lab abnormalities [ Time Frame: at week 52 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00781105

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Novartis Investigative Site
Beijing, China
Sponsors and Collaborators
Novartis Pharmaceuticals
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Principal Investigator: Jia Jidong, Dr. Beijing Friendship Hospital
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00781105    
Other Study ID Numbers: CLDT600ACN03
First Posted: October 28, 2008    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Chronic hepatitis B
HBV DNA suppression
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action