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Adefovir and Lamivudine for Entecavir Resistance (ALTER Study)

NCT01546116 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-02-17

No results posted yet for this study

Summary

* Entecavir has been one of the option for treatment of lamivudine resistant chronic hepatitis B (CHB).
* In case of entecavir resistance, adefovir could be used. However, sequential monotherapy may result in multidrug resistance.
* It is thought that adefovir and lamivudine combination therapy reduce the risk of adefovir resistance, thereby continued therapy will lead to suppression of hepatitis B virus (HBV) DNA to be undetectable in patients with entecavir resistance.
* This study aim to evaluate the efficacy of adefovir and lamivudine combination therapy in CHB patients with entecavir resistance.

Conditions

Interventions

DRUG

ADEFOVIR, LAMIVUDINE

Adefovir/10mg tablet/once a day/52week Lamivudine/100mg tablet/once a day/52week

Sponsors & Collaborators

Principal Investigators

  • HYUNG JOON YIM, M.D., Ph.D. · Korea University Ansan Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-02-29
Completion
2014-02-28

Countries

  • South Korea

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01546116 on ClinicalTrials.gov