NCT00376259

Brief Summary

This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently approved by the Food and Drug Administration \[FDA\] for the treatment of hepatitis B virus \[HBV\]) versus adefovir dipivoxil used alone. The results for patients taking the combination therapy will be compared to the results for patients taking adefovir alone.

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at below P25 for phase_3

Geographic Reach
5 countries

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

May 17, 2011

Completed
Last Updated

June 30, 2011

Status Verified

June 1, 2011

Enrollment Period

1.6 years

First QC Date

September 13, 2006

Results QC Date

December 20, 2010

Last Update Submit

June 28, 2011

Conditions

Hepatitis B

Keywords

lamivudine resistanceHepatitis B virus

Outcome Measures

Primary Outcomes (1)

  • The Proportion of Participants Who Experienced Virologic Breakthrough

    Virologic breakthrough is defined as a minimum of 1 log reduction from baseline followed by a 1 log increase from nadir on at least 2 consecutive visits including the last treatment visit.

    96 Weeks

Secondary Outcomes (3)

  • Change From Baseline in Mean Hepatitis B Virus (HBV) DNA Concentration

    Baseline to 12 weeks, 24 weeks, 48 weeks and 60 weeks

  • Percentage of Participants Achieving Specified Clinical and Laboratory Safety Criteria

    12 week, 24 week, 48 week and 60 weeks

  • Proportion of Participants With Treatment-emergent HBV Resistance Mutations Associated With Virologic Breakthrough

    Week 96

Study Arms (2)

Combination therapy

EXPERIMENTAL

Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.

Drug: telbivudineDrug: adefovir dipivoxil

Adefovir monotherapy

ACTIVE COMPARATOR

Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.

Drug: adefovir dipivoxil

Interventions

telbivudineDRUG

600mg/day oral tablet for 96 weeks

Combination therapy
adefovir dipivoxilDRUG

10 mg of adefovir by mouth once daily

Adefovir monotherapyCombination therapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented compensated chronic hepatitis B defined by a clinical history compatible with chronic hepatitis B.
  • Previous or current lamivudine treatment
  • HBV DNA \> 6 log10 copies/mL
  • Evidence of viral breakthrough

You may not qualify if:

  • Patient is pregnant or breastfeeding.
  • Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV.
  • Patient has received any anti-HBV treatment for HBV infection other than lamivudine in the 12 months before Screening for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Novartis

San Diego, California, United States

Location

Unknown Facility

San Mateo, California, United States

Location

Unknown Facility

Pok Fu Lam, Hong Kong

Location

Unknown Facility

Seoul, South Korea

Location

Novarits

Kaohsuing, Taiwan

Location

Unknown Facility

Bangkok, Thailand

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

Telbivudineadefovir dipivoxil

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Limitations and Caveats

The study was not completed as planned and was terminated early with agreement from the European Medicines Agency (EMEA).

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2006

First Posted

September 14, 2006

Study Start

January 1, 2007

Primary Completion

August 1, 2008

Last Updated

June 30, 2011

Results First Posted

May 17, 2011

Record last verified: 2011-06

Locations

HK(1)TW(1)KR(1)US(2)TH(1)