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

This study has been completed.
Sponsor:
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00558493
First received: November 14, 2007
Last updated: July 24, 2012
Last verified: July 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

Drug Information available for: Lamivudine
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00558493

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

No publications provided

Responsible Party: __
ClinicalTrials.gov Identifier: NCT00558493     History of Changes
Other Study ID Numbers: KB-406, KB-406
Study First Received: November 14, 2007
Last Updated: July 24, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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
2'-fluoro-5-methylarabinosyluracil
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 22, 2013