NCT00558493

Brief Summary

A multi-center and open study to compare the safety and effectiveness of switching treatment from lamivudine to clevudine for 24 weeks.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2007

Completed
Last Updated

July 26, 2012

Status Verified

July 1, 2012

First QC Date

November 14, 2007

Last Update Submit

July 24, 2012

Conditions

Chronic Hepatitis B

Study Arms (1)

1

EXPERIMENTAL

switching treatment from lamivudine to clevudine

Drug: Clevudine

Interventions

ClevudineDRUG

clevudine 30 mg qd for 24 seeks

1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 \[kg\])\] / \[(72) (serum creatinine\] \[mg/dL\])\[Note: multiply estimates by 0.85 for women\]

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Youngnam University Medical Center

Daegu, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

clevudine

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 14, 2007

First Posted

November 15, 2007

Study Start

November 1, 2007

Last Updated

July 26, 2012

Record last verified: 2012-07

Locations

KR(1)