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Switching Study From Lamivudine to Clevudine in the Chronic Hepatitis B Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00558493
First Posted: November 15, 2007
Last Update Posted: July 26, 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:
Bukwang Pharmaceutical
  Purpose
A multi-center and open study to compare the safety and effectiveness of switching treatment from lamivudine to clevudine for 24 weeks.

Condition Intervention Phase
Chronic Hepatitis B Drug: Clevudine Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase lV Study to Evaluate the Safety and Effectiveness of Switching Treatment From Lamivudine to Clevudine in the Chronic Hepatitis B Patients With Suboptimal Virologic Response During Lamivudine Treatment

Resource links provided by NLM:


Further study details as provided by Bukwang Pharmaceutical:

Estimated Enrollment: 100
Study Start Date: November 2007
Arms Assigned Interventions
Experimental: 1
switching treatment from lamivudine to clevudine
Drug: Clevudine
clevudine 30 mg qd for 24 seeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HBV DNA > 2,000 copies/mL at screening
  • Patients who have compensated liver disease (Child-Pugh score =<6)
  • Patients without LMV resistant mutation by RFMP assay
  • Patients who have NOT experienced viral breakthrough at consecutive two measurements (at least one month apart) during lamivudine monotherapy
  • Patients who can submit the written consent and comply with the claims postulated of this clinical trial

Exclusion Criteria:

  • Currently receiving antiviral except LMV or corticosteroid therapy
  • Patients that previously received antiviral treatment for hepatitis B other than lamivudine in the proceeding 12 months
  • Previous treatment with interferon or other immunomodulatory therapies must have ended at least 6 months preceding the study screening
  • Treatment with nephrotoxic drugs, competitors of renal excretion, and/or hepatotoxic drugs within 2 months before study screening or during the study period
  • Patients who is co-infected with HCV, HDV or HIV
  • Serious concurrent medical conditions
  • Prior organ transplantation
  • Patient has creatinine clearance less than 60mL/min as estimated by the following formula:

[(140-age in years) (body weight [kg])] / [(72) (serum creatinine] [mg/dL])[Note: multiply estimates by 0.85 for women]

  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): NCT00558493


Locations
Korea, Republic of
Youngnam University Medical Center
Daegu, Korea, Republic of
Sponsors and Collaborators
Bukwang Pharmaceutical
  More Information

ClinicalTrials.gov Identifier: NCT00558493     History of Changes
Other Study ID Numbers: KB-406
First Submitted: November 14, 2007
First Posted: November 15, 2007
Last Update Posted: July 26, 2012
Last Verified: July 2012

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
Clevudine
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