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

This study is currently recruiting participants.
Verified January 2012 by Yonsei University
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
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis B
 Drug: telbivudine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Virologic response [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety, virologic breakthrough and biochemical response [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: June 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: telbivudine
    600mg, oral daily over 12 months
  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01270165

Contacts
Contact: Han Jak Ryu, Dr. +82-10-2329-2379 hanjak@yuhs.ac

Locations
Korea, Republic of
Department of Internal Medicine, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Han Jak Ryu, Dr.     +82-10-2329-2379     hanjak@yuhs.ac    
Contact: Jun Yong Park, Dr.     +82-2-2228-1994     DRPJY@yuhs.ac    
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Sang Hoon Ahn, MD, PhD Department of Internal Medicine, Yonsei University College of Medicine
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01270165     History of Changes
Other Study ID Numbers: 4-2010-0168
Study First Received: January 4, 2011
Last Updated: January 31, 2012
Health Authority: Republic of Korea: Institutional Review Board

Keywords provided by Yonsei University:
lamivudine
telbivudine
adefovir
lamivudine resistance

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
 Adefovir
Adefovir dipivoxil
Lamivudine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 16, 2013