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Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone

NCT ID: NCT00376259

Last Updated: 2011-06-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis B

Keywords

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lamivudine resistance Hepatitis B virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Combination therapy

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

Group Type EXPERIMENTAL

telbivudine

Intervention Type DRUG

600mg/day oral tablet for 96 weeks

adefovir dipivoxil

Intervention Type DRUG

10 mg of adefovir by mouth once daily

Adefovir monotherapy

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

Group Type ACTIVE_COMPARATOR

adefovir dipivoxil

Intervention Type DRUG

10 mg of adefovir by mouth once daily

Interventions

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telbivudine

600mg/day oral tablet for 96 weeks

Intervention Type DRUG

adefovir dipivoxil

10 mg of adefovir by mouth once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis

Locations

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Novartis

San Diego, California, United States

Site Status

San Mateo, California, United States

Site Status

Pok Fu Lam, , Hong Kong

Site Status

Seoul, , South Korea

Site Status

Novarits

Kaohsuing, , Taiwan

Site Status

Bangkok, , Thailand

Site Status

Countries

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United States Hong Kong South Korea Taiwan Thailand

Other Identifiers

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CLDT600A2304

Identifier Type: -

Identifier Source: org_study_id