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A Study With Clevudine Monotherapy or Adefovir and Clevudine Combination in Proportion to Roadmap Concept in Patients With HBV Associated-HCC

NCT01263002 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2014-12-18

No results posted yet for this study

Summary

An open study to evaluate the Efficacy, Safety of Clevudine monotherapy or Adefovir and Clevudine combination in Proportion to Roadmap Concept in patients with chronic hepatitis B Associated Hepatocellular Carcinoma

Conditions

  • Hepatitis B Associated Hepatocellular Carcinoma

Interventions

DRUG

clevudine, Adefovir

Nucleoside-analogue naive patient : Clevudine 30mg qd 1. Assess the complete virological response(HBV DNA \< 60 IU/ml) at 24 weeks: Only Clevudine 30mg qd 2. Assess not the complete virological response at 24 weeks : Add Adefovir 10mg qd 3. During medication of Clevudine, virological breakthrough : add adefovir 10mg qd 4. During treatment period, composite virological response : stop the medication and F/U for 2 years 5. Recurrence after stopping treatment(HBV DNA \> 2,000IU/ml) retreat medication at composite virological response. * complete virological response: HBV DNA \< 60 IU/ml * virological breakthrough : During antiviral treatment, HBV DNA increased from nadir to 1 log10IU/ml continuously.

Sponsors & Collaborators

  • Bukwang Pharmaceutical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-01-31
Completion
2013-09-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01263002 on ClinicalTrials.gov