HBeAg(-) Chronic Hepatitis B With Compensated Liver Function Clinical Trial
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
| NCT number | NCT00641082 |
| Other study ID # | CLV-401 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | March 5, 2008 |
| Last updated | April 24, 2012 |
| Start date | February 2008 |
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.
| Status | Completed |
| Enrollment | 43 |
| Est. completion date | |
| Est. primary completion date | March 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
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] |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Seoul National University Bundang Hospital | Bundang | |
| Korea, Republic of | Seoul National University Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Bukwang Pharmaceutical |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of patients with HBV DNA below 300copies/mL | at week 48 | ||
| Secondary | The change of HBV DNA from the baseline | at week 24, 48 | ||
| Secondary | Proportion of patients with HBV DNA below LOD of RT-PCR | at week 24, 48 | ||
| Secondary | ALT normalization rate | at week 24, 48 | ||
| Secondary | Proportion of patients with viral breakthrough during 48-week treatment period | at week 24, 48 |