Entecavir Plus Adefovir in Lamivudine-Resistant Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2014-06-30

Brief Summary

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Combination therapy with entecavir 1.0 mg plus adefovir 10 mg has superior antiviral activity compared with either entecavir monotherapy 1.0 mg or adefovir 10 mg plus lamivudine 100 mg in Chinese adults with lamivudine-resistant chronic hepatitis B infection

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Detailed Description

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Conditions

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Hepatitis B, Chronic

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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Lamivudine plus Adefovir

Group Type ACTIVE_COMPARATOR

Lamivudine

Intervention Type DRUG

Tablets, Oral, 100mg, once daily, 48-96 weeks depending on response

Adefovir

Intervention Type DRUG

Tablets, Oral, 10mg, once daily, 48-96 weeks depending on response

Entecavir

Group Type ACTIVE_COMPARATOR

Entecavir

Intervention Type DRUG

Tablets, Oral, 1mg, once daily, 48-96 weeks depending on response

Entecavir plus Adefovir

Group Type EXPERIMENTAL

Entecavir

Intervention Type DRUG

Tablets, Oral, 1mg, once daily, 48-96 weeks depending on response

Adefovir

Intervention Type DRUG

Tablets, Oral, 10mg, once daily, 48-96 weeks depending on response

Interventions

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Lamivudine

Tablets, Oral, 100mg, once daily, 48-96 weeks depending on response

Intervention Type DRUG

Entecavir

Tablets, Oral, 1mg, once daily, 48-96 weeks depending on response

Intervention Type DRUG

Adefovir

Tablets, Oral, 10mg, once daily, 48-96 weeks depending on response

Intervention Type DRUG

Other Intervention Names

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Heptotin Baraclude Hepsera

Eligibility Criteria

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Inclusion Criteria

* CHB HBeAg(+) Subject with Lamivudine treatment history must have LVDr substitution at rtM204V/I
* Naïve to nucleoside/nucleotide analogues except for LVD
* HBV DNA \> 17,200 IU/mL
* Compensated liver function
* Serum ALT \<10 × ULN

Exclusion Criteria

* Women who are pregnant or breastfeeding
* Evidence of decompensated cirrhosis
* Coinfection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No