NCT01263002

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

An Open Study to Evaluate the Efficacy, Safety and Sustained Effect of Clevudine Monotherapy or Adefovir and Clevudine Combination in Proportion to Roadmap Concept in Patients With Chronic Hepatitis B Associated Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Bukwang Pharmaceutical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2010-06-01
• Primary completion: 2013-01-01
• Completion: 2013-09-01
• First posted: 2010-12-20
• Last updated: 2014-12-18

Locations

1 site across 1 country: South Korea