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
1 other identifier
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 4, 2011
CompletedFirst Posted
Study publicly available on registry
January 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedFebruary 2, 2012
January 1, 2012
1.9 years
January 4, 2011
January 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Virologic response
1 year
Secondary Outcomes (1)
Safety, virologic breakthrough and biochemical response
1 year
Interventions
600mg, oral daily over 12 months
Eligibility Criteria
You may qualify if:
- HBeAg positive
- lamivudine and adefovir at least 12 months over 6 months lamivudine treatment for YMDD positive patients
- HBV DNA over 300 copies/ml
You may not qualify if:
- decompensated cirrhosis
- renal failure
- prior interferon usage
- evidence of HCC or prior organ transplantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Internal Medicine, Yonsei University College of Medicine
Seoul, 120-752, South Korea
Related Publications (1)
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.
PMID: 24431895DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sang Hoon Ahn, MD, PhD
Department of Internal Medicine, Yonsei University College of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2011
First Posted
January 5, 2011
Study Start
June 1, 2010
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
February 2, 2012
Record last verified: 2012-01