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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Yonsei University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01270165
First received: January 4, 2011
Last updated: January 31, 2012
Last verified: January 2012

January 4, 2011
January 31, 2012
June 2010
May 2012   (final data collection date for primary outcome measure)
Virologic response [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01270165 on ClinicalTrials.gov Archive Site
Safety, virologic breakthrough and biochemical response [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis B
Drug: telbivudine
600mg, oral daily over 12 months
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 70 Years
No
Contact: Han Jak Ryu, Dr. +82-10-2329-2379 hanjak@yuhs.ac
Korea, Republic of
 
NCT01270165
4-2010-0168
Yes
Yonsei University
Yonsei University
Not Provided
Principal Investigator: Sang Hoon Ahn, MD, PhD Department of Internal Medicine, Yonsei University College of Medicine
Yonsei University
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP