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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Yonsei University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01270165
First Posted: January 5, 2011
Last Update Posted: February 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Virologic response [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Safety, virologic breakthrough and biochemical response [ Time Frame: 1 year ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01270165     History of Changes
Other Study ID Numbers: 4-2010-0168
First Submitted: January 4, 2011
First Posted: January 5, 2011
Last Update Posted: February 2, 2012
Last Verified: January 2012

Keywords provided by Yonsei University:
lamivudine
telbivudine
adefovir
lamivudine resistance

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