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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
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

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

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

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

No publications provided

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
Adult
HBV DNA suppression
Telbivudine

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on May 23, 2013