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

February 20, 2017 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HBV DNA PCR negativity rate
Time Frame: at 52 weeks
at 52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
HBV DNA PCR negativity rate
Time Frame: at week 24
at week 24
DNA reduction
Time Frame: from baseline to Weeks 12, 24, 36, 52
from baseline to Weeks 12, 24, 36, 52
HBeAg loss rate
Time Frame: at week 52
at week 52
HBeAg seroconversion rate
Time Frame: at week 52
at week 52
ALT normalization rate
Time Frame: at weeks 24 and 52
at weeks 24 and 52
Incidence of AE (SAE,etc), Graded lab abnormalities
Time Frame: at week 52
at week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Principal Investigator: Jia Jidong, Dr., Beijing Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2008

Primary Completion (Actual)

September 16, 2010

Study Completion (Actual)

September 16, 2010

Study Registration Dates

First Submitted

October 27, 2008

First Submitted That Met QC Criteria

October 27, 2008

First Posted (Estimate)

October 28, 2008

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 20, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLDT600ACN03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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