A Double-Blind Randomized Clinical Trial Comparing the Safety and Antiviral Activity of 48-week Clevudine and Adefovir Dipivoxil in HBeAg(-) Chronic Hepatitis B With Compensated Liver Function

This study has been completed.
Sponsor:
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00641082
First received: March 5, 2008
Last updated: April 24, 2012
Last verified: April 2012

March 5, 2008
April 24, 2012
February 2008
March 2012   (final data collection date for primary outcome measure)
Proportion of patients with HBV DNA below 300copies/mL [ Time Frame: at week 48 ]
Same as current
Complete list of historical versions of study NCT00641082 on ClinicalTrials.gov Archive Site
  • The change of HBV DNA from the baseline [ Time Frame: at week 24, 48 ]
  • Proportion of patients with HBV DNA below LOD of RT-PCR [ Time Frame: at week 24, 48 ]
  • ALT normalization rate [ Time Frame: at week 24, 48 ]
  • Proportion of patients with viral breakthrough during 48-week treatment period [ Time Frame: at week 24, 48 ]
Same as current
Not Provided
Not Provided
 
A Double-Blind Randomized Clinical Trial Comparing the Safety and Antiviral Activity of 48-week Clevudine and Adefovir Dipivoxil in HBeAg(-) Chronic Hepatitis B With Compensated Liver Function
A Double-Blind Randomized Clinical Trial Comparing the Safety and Antiviral Activity of 48-week Clevudine and Adefovir Dipivoxil in HBeAg(-) Chronic Hepatitis B With Compensated Liver Function

A double-blind randomized, parallel, multicenter with 48 weeks of treatment period. The purpose of this study is to compare the safety and antiviral activity of 48-week Clevudine and Adefovir dipivoxil in HBeAg(-) Chronic Hepatitis B with compensated liver function.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HBeAg(-) Chronic Hepatitis B With Compensated Liver Function
  • Drug: Clevudine
    30mg for 48 weeks
    Other Name: Levovir
  • Drug: Adefovir dipivoxil
    10mg for 48 weeks
    Other Name: Hepsera
  • Experimental: 1
    Clevudine
    Intervention: Drug: Clevudine
  • Active Comparator: 2
    Adefovir
    Intervention: Drug: Adefovir dipivoxil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
Not Provided
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient is between 18 and 60
  • Patient is documented to be HBsAg positive for > 6 months.
  • Patient with compensated hepatic function.
  • Nucleoside treatment-naÃ-ve subjects of either gender
  • Patient is HBeAg negative. Patient is HBV DNA positive with DNA levels ≥ 1 x 10(5) copies/mL within 30 days of baseline.
  • Patient has ALT levels which are in the range of 2 x ULN and < 10 X ULN
  • Patient who has not a history of ascites, variceal hemorrhage or hepatic encephalopathy.

Exclusion Criteria

  • Patient is currently receiving antiviral or corticosteroid therapy.
  • Patients previously treated with lamivudine, adefovir, entecavir, telbivudine, clevudine, lobucavir, famciclovir or any other investigational nucleoside for HBV infection.
  • Previous treatment with interferon must have ended at least 6 months prior to the screening visit.
  • Treatment with nephrotoxic drugs, competitors of renal excretion, and/or hepatotoxic drugs within 2 months before study screening or during the study period
  • Subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening visit.
  • Patient is coinfected with HCV, HDV or HIV.
  • Patient with following clinical evidence

    • Decompensated liver cirrhosis (Child class B,C: CPT score 7) or hepatocellular carcinoma
    • Significant gastrointestinal, renal, bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease
  • Previous organ transplantation
  • Patient has a clinically relevant history of abuse of alcohol or drugs.
  • Patient is pregnant or breast-feeding.
  • Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases.
  • Patient has α-Fetoprotein more than 100ng/mL
  • Patient has Hemoglobin <11g/dL (Male), 10g/dL (Female) or WBC count < 3,500/mm3 (PMN<1,500/mm3) or Platelet count <50,000/mm3
  • 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]
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00641082
CLV-401
Not Provided
Not Provided
Bukwang Pharmaceutical
Not Provided
Not Provided
Bukwang Pharmaceutical
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP