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

Antiviral Efficacy of Continuing Lamivudine Plus Adefovir or Switching to Telbivudine Plus Adefovir in HBeAg-positive Lamivudine-refractory Chronic Hepatitis B Patients Who Have Suboptimal Response to Lamivudine Plus Adefovir for at Least 12 Months

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01270165

Enrollment

110

Registered

2011-01-05

Start date

2010-06-30

Completion date

2012-05-31

Last updated

2012-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Keywords

lamivudine, telbivudine, adefovir, lamivudine resistance

Brief summary

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.

Interventions

DRUGtelbivudine

600mg, oral daily over 12 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Virologic response	1 year

Secondary

Measure	Time frame
Safety, virologic breakthrough and biochemical response	1 year

Countries

South Korea

Contacts

Primary ContactHan Jak Ryu, Dr.

hanjak@yuhs.ac+82-10-2329-2379

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026