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

Primary Purpose

Chronic Hepatitis B

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
telbivudine
Sponsored by
Yonsei University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring lamivudine, telbivudine, adefovir, lamivudine resistance

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Internal Medicine, Yonsei University College of MedicineRecruiting

Outcomes

Primary Outcome Measures

Virologic response

Secondary Outcome Measures

Safety, virologic breakthrough and biochemical response

Full Information

First Posted
January 4, 2011
Last Updated
January 31, 2012
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01270165
Brief Title
Lamivudine Plus Adefovir Versus Telbivudine Plus Adefovir in Lamivudine Resistant Chronic Hepatitis B
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
May 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
lamivudine, telbivudine, adefovir, lamivudine resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
telbivudine
Intervention Description
600mg, oral daily over 12 months
Primary Outcome Measure Information:
Title
Virologic response
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Safety, virologic breakthrough and biochemical response
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Han Jak Ryu, Dr.
Phone
+82-10-2329-2379
Email
hanjak@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Hoon Ahn, MD, PhD
Organizational Affiliation
Department of Internal Medicine, Yonsei University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han Jak Ryu, Dr.
Phone
+82-10-2329-2379
Email
hanjak@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Jun Yong Park, Dr.
Phone
+82-2-2228-1994
Email
DRPJY@yuhs.ac

12. IPD Sharing Statement

Citations:
PubMed Identifier
24431895
Citation
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.
Results Reference
derived

Learn more about this trial

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

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