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

Phase 3

Completed

• Conditions: Patients With LC-B
• Interventions: Drug: Clevudine; Drug: Adefovir dipivoxil

• Registration Number: NCT00672867
• Lead Sponsor: Bukwang Pharmaceutical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-05-02
• Study First Submitted QC: 2008-05-02
• Study First Posted: 2008-05-06
• Status Verified: 2012-07
• Primary Completion: 2012-11
• Study Completion: 2014-09
• Last Update Submitted: 2014-12-17
• Last Update Posted: 2014-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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]

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Clevudine	Clevudine
2	Adefovir dipivoxil	Adefovir

Primary Outcome Measures

Name	Time	Method
Proportion of patients with HBV DNA below 12 IU/mL by Real-Time PCR

Secondary Outcome Measures

Name	Time	Method
The change of HBV DNA from the baseline.
Child-Pugh score improvement
MELD score improvement
Biochemical improvement
Proportion of patients with HBeAg loss and/or seroconversion

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of