NCT01263002 - A Study With Clevudine Monotherapy or Adefovir and Clevudine Combination in Proportion to Roadmap Concept in Patients With HBV Associated-HCC | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

January 31, 2013

Study Completion Date

September 30, 2013

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."

Trial Locations (1)

Unknown

Seoul National University Hospital, Seoul