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Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B

Primary Purpose

Chronic Hepatitis B

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Telbivudine (LdT)
Adefovir Dipivoxil
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All Sexes

Inclusion Criteria: Documented compensated chronic hepatitis B defined by clinical history compatible with compensated chronic hepatitis B Detectable serum HBsAg at the Screening visit Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Patient is pregnant or breastfeeding. Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV Patient previously received lamivudine, adefovir dipivoxil, or an investigational anti-hepatitis B virus (HBV) nucleoside or nucleotide analog at any time Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study Other protocol-defined exclusion criteria may apply.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 21, 2005
Last Updated
May 8, 2015
Sponsor
Novartis
Collaborators
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00115245
Brief Title
Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B
Official Title
A Randomized, Open-Label Trial of Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis
Collaborators
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
This research study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (telbivudine) versus adefovir dipivoxil, a drug approved by the Food and Drug Administration (FDA) for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking adefovir dipivoxil.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Telbivudine (LdT)
Intervention Type
Drug
Intervention Name(s)
Adefovir Dipivoxil

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Eligibility Criteria
Inclusion Criteria: Documented compensated chronic hepatitis B defined by clinical history compatible with compensated chronic hepatitis B Detectable serum HBsAg at the Screening visit Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Patient is pregnant or breastfeeding. Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV Patient previously received lamivudine, adefovir dipivoxil, or an investigational anti-hepatitis B virus (HBV) nucleoside or nucleotide analog at any time Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study Other protocol-defined exclusion criteria may apply.
Facility Information:
City
Los Angeles
State/Province
California
Country
United States
City
Pasadena
State/Province
California
Country
United States
City
San Francisco
State/Province
California
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Clayton
Country
Australia
City
Wooloongabba
Country
Australia
City
Calgary
Country
Canada
City
Toronto
Country
Canada
City
Winnipeg
Country
Canada
City
Hong Kong
Country
China
City
Paris
Country
France
City
Seoul
Country
Korea, Republic of
City
Singapore
Country
Singapore
City
Taipei
Country
Taiwan
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
17909201
Citation
Chan HL, Heathcote EJ, Marcellin P, Lai CL, Cho M, Moon YM, Chao YC, Myers RP, Minuk GY, Jeffers L, Sievert W, Bzowej N, Harb G, Kaiser R, Qiao XJ, Brown NA; 018 Study Group. Treatment of hepatitis B e antigen positive chronic hepatitis with telbivudine or adefovir: a randomized trial. Ann Intern Med. 2007 Dec 4;147(11):745-54. doi: 10.7326/0003-4819-147-11-200712040-00183. Epub 2007 Oct 1.
Results Reference
derived

Learn more about this trial

Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B

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