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

NCT ID: NCT00672867

Last Updated: 2014-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2014-09-30

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.

Conditions

Patients With LC-B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Clevudine

Group Type: EXPERIMENTAL

Clevudine

Intervention Type: DRUG

30mg

2

Adefovir

Group Type: ACTIVE_COMPARATOR

Adefovir dipivoxil

Intervention Type: DRUG

10mg

Interventions

Clevudine

30mg

Intervention Type: DRUG

Adefovir dipivoxil

10mg

Intervention Type: DRUG

Other Intervention Names

Levovir; Hepsera

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]

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bukwang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

L-FMAU-309

Identifier Type: -

Identifier Source: org_study_id