Status:
COMPLETED
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
Lead Sponsor:
Bukwang Pharmaceutical
Conditions:
HBeAg(-) Chronic Hepatitis B With Compensated Liver Function
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
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 dipivoxi...
Eligibility Criteria
Inclusion
- 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 \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00641082
Start Date
February 1 2008
Last Update
April 25 2012
Active Locations (2)
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1
Seoul National University Bundang Hospital
Bundang, South Korea
2
Seoul National University Hospital
Seoul, South Korea