Clinical trial NCT00672867: A Pilot Study to Evaluate the Safety and Efficacy of Clevudine or Adefovir Patients With LC-B
Official title: A Open Randomized Clinical Trial Comparing the Efficacy and Safety of Clevudine 30mg Versus Adefovir 10mg in Patients With LC-B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Patients With LC-B
Lead sponsor: Bukwang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-05-06
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and antiviral activity of Clevudine Versus Adefovir dipivoxil in patients with LC-B.


Eligibility criteria: Inclusion Criteria:

1. Patient is 18 years and older.
2. 5 ≦ Child-Pugh score ≦ 12
3. Patient is HBV DNA positive with DNA levels ≥ 1 x 10(4) copies/mL within 30 days of baseline.
4. Patient is documented to be HBsAg positive for \> 6 months.
5. Patient is HBeAg positive or negative.
6. Patient has ALT or AST levels which are in the range of \> 1 x ULN and \< 15 X ULN
7. Patient with liver cirrhosis diagnosed by imaging study within 1 year or clinical evidence of portal hypertension
8. Life expectancy of at least 12 months
9. Female patient with a negative urine(Beta-HCG) pregnancy test taken within 14 days of starting therapy.
10. Patient who is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
2. Previous treatment with interferon must have ended at least 6 months prior to the screening visit.
3. Patients previously treated with clevudine, entecavir, lamivudine, adefovir, telbivudine or any other investigational nucleoside for HBV infection.
4. Patient is coinfected with HCV, HDV or HIV.
5. Patient with clinical evidence of hepatocellular carcinoma
6. Patient has alpha-fetoprotein \> 400ng/mL.
7. Patient has Hemoglobin \<8g/dL (Male), 7.5g/dL (Female) or WBC \<1,500mm3 or Neutrophils \<500/mm3 or Platelet count \<30,000/mm3.
8. Patient is pregnant or breast-feeding.
9. 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.
10. Patient has a clinically relevant history of abuse of alcohol or drugs.
11. Patient with previous liver transplantation
12. Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.
13. 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 12 IU/mL by Real-Time PCR
Secondary outcomes:
measure: The change of HBV DNA from the baseline.
measure: Child-Pugh score improvement
measure: MELD score improvement
measure: Biochemical improvement
measure: Proportion of patients with HBeAg loss and/or seroconversion
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: