Lamivudine Plus Adefovir Versus Telbivudine Plus Adefovir in Lamivudine Resistant Chronic Hepatitis B

NCT ID: NCT01270165

Last Updated: 2012-02-02

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-05-31

Brief Summary

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No study has reported on the comparative effect of continuing lamivudine plus adefovir versus switching to telbivudine plus adefovir in HBeAg-positive lamivudine-refractory chronic hepatitis B patients who have suboptimal response to lamivudine plus adefovir. The goal of this study is to compare the efficacy of continuing lamivudine plus adefovir versus switching to telbivudine plus adefovir directly in patients with lamivudine-refractory chronic hepatitis B patients who have suboptimal response to lamivudine plus adefovir for at least 12 months.

Detailed Description

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Conditions

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Chronic Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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telbivudine

600mg, oral daily over 12 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* HBeAg positive
* lamivudine and adefovir at least 12 months over 6 months lamivudine treatment for YMDD positive patients
* HBV DNA over 300 copies/ml

Exclusion Criteria

* decompensated cirrhosis
* renal failure
* prior interferon usage
* evidence of HCC or prior organ transplantation
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sang Hoon Ahn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Yonsei University College of Medicine

Locations

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Department of Internal Medicine, Yonsei University College of Medicine

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Han Jak Ryu, Dr.

Role: CONTACT

+82-10-2329-2379

Facility Contacts

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Han Jak Ryu, Dr.

Role: primary

+82-10-2329-2379

Jun Yong Park, Dr.

Role: backup

+82-2-2228-1994

References

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Park H, Park JY, Kim SU, Kim DY, Han KH, Chon CY, Ahn SH. Efficacy of switching to telbivudine plus adefovir in suboptimal responders to lamivudine plus adefovir. World J Gastroenterol. 2013;19(43):7671-9. doi: 10.3748/wjg.v19.i43.7671.

Reference Type DERIVED
PMID: 24431895 (View on PubMed)

Other Identifiers

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4-2010-0168

Identifier Type: -

Identifier Source: org_study_id

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