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

Primary Purpose

Chronic Hepatitis B

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Telbivudine
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring Chronic hepatitis B, Adult, HBV DNA suppression, Telbivudine

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

HBV DNA PCR negativity rate

Secondary Outcome Measures

HBV DNA PCR negativity rate
DNA reduction
HBeAg loss rate
HBeAg seroconversion rate
ALT normalization rate
Incidence of AE (SAE,etc), Graded lab abnormalities

Full Information

First Posted
October 27, 2008
Last Updated
February 20, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00781105
Brief Title
Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B
Acronym
Chinese PAC
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 1, 2008 (Actual)
Primary Completion Date
September 16, 2010 (Actual)
Study Completion Date
September 16, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
Chronic hepatitis B, Adult, HBV DNA suppression, Telbivudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Telbivudine
Intervention Description
600 mg/day, oral tablets, once daily, 52 weeks
Primary Outcome Measure Information:
Title
HBV DNA PCR negativity rate
Time Frame
at 52 weeks
Secondary Outcome Measure Information:
Title
HBV DNA PCR negativity rate
Time Frame
at week 24
Title
DNA reduction
Time Frame
from baseline to Weeks 12, 24, 36, 52
Title
HBeAg loss rate
Time Frame
at week 52
Title
HBeAg seroconversion rate
Time Frame
at week 52
Title
ALT normalization rate
Time Frame
at weeks 24 and 52
Title
Incidence of AE (SAE,etc), Graded lab abnormalities
Time Frame
at week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia Jidong, Dr.
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis Investigative Site
City
Beijing
Country
China

12. IPD Sharing Statement

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

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