A Pilot Study to Evaluate the Safety and Efficacy of Clevudine or Adefovir Patients With LC-B

Bukwang Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Patients With LC-B

Treatments: Drug: Adefovir dipivoxil; Drug: Clevudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00672867

L-FMAU-309

Details and patient eligibility

About

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

Enrollment: 102 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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]

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

1

Experimental group

Description:

Clevudine

Treatment:

Drug: Clevudine

2

Active Comparator group

Description:

Adefovir

Treatment:

Drug: Adefovir dipivoxil