Clinical trial NCT00641082: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HBeAg(-) Chronic Hepatitis B With Compensated Liver Function
Lead sponsor: Bukwang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-03-21
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 dipivoxil in HBeAg(-) Chronic Hepatitis B with compensated liver function.


Eligibility criteria: 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 â‰¥ 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 Î±-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 \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]

Primary outcomes:
measure: Proportion of patients with HBV DNA below 300copies/mL
timeFrame: at week 48
Secondary outcomes:
measure: The change of HBV DNA from the baseline
timeFrame: at week 24, 48
measure: Proportion of patients with HBV DNA below LOD of RT-PCR
timeFrame: at week 24, 48
measure: ALT normalization rate
timeFrame: at week 24, 48
measure: Proportion of patients with viral breakthrough during 48-week treatment period
timeFrame: at week 24, 48
Other outcomes:
Locations:
city: Bundang
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: