Safety and Efficacy Study of Clevudine Compared With Clevudine and Vaccine in Patient With HBeAg(+) Chronic HBV
NCT ID: NCT00501124
Last Updated: 2010-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
70 participants
INTERVENTIONAL
2007-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Clevudine
Purified hepatitis B surface antigen
Eligibility Criteria
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Inclusion Criteria
2. Patient is HBV DNA positive with DNA levels ≥ 5 x 10(6) copies/mL within 30 days of baseline.
3. Patient is documented to be HBsAg positive for \> 6 months. Patient is HBeAg positive.
4. Patient has ALT levels which are in the range of ≥2 x ULN/L at least 2 consecutive visits, at least one month apart and bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), a serum albumin level of at least 3.5 g/dL.
5. Women of childbearing potential must have a negative urine (β-HCG) pregnancy test taken within 14 days of starting therapy.
6. Patient is able to give written informed consent prior to study start and to comply with the study requirements.
Exclusion Criteria
2. Patients previously treated with interferon, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
3. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
4. Patient is coinfected with HCV, HDV or HIV.
5. Patient with clinical evidence of decompensated liver disease or HCC
6. ANA \> 1:160 and positive anti-smooth muscle antibody as evidence of autoimmune hepatitis
7. Patient is pregnant or breast-feeding.
8. 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.
9. Patient has a clinically relevant history of abuse of alcohol or drugs.
10. Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic or allergic disease or medical illness that in the investigator's opinion might interfere with therapy. The patient with a benign tumor, excluded if judged by an investigator that the continuation of study would be interfered by the tumor.
11. Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
18 Years
60 Years
ALL
No
Sponsors
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Bukwang Pharmaceutical
INDUSTRY
Responsible Party
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Chungnam University Hospital
Principal Investigators
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Heon Young Lee, MD. PhD.
Role: PRINCIPAL_INVESTIGATOR
Chungnam National University Hospital
Hyeon Woong Yang, MD. PhD.
Role: PRINCIPAL_INVESTIGATOR
Eulji University Hospital
Locations
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Dankook University Hospital
Anseo-dong, Cheonan Si, Chungcheongnam-do, South Korea
Soon Chun Hyang University Cheonan Hospital
Bongmyeong-dong, Cheonan Si, Chungcheongnam-do, South Korea
The Catholic University of Korea, Daejeon St. Mary's Hospital
Daeheung-dong, Jung-gu, Daejeon, South Korea
Chungnam National University Hospital
Daesa-dong, Jung-gu, Daejeon, South Korea
Eulji University Hospital
Dunsan 2-dong, Seo-gu, Daejeon, South Korea
Konyang University Hospital
Gasuwon-dong, Seo-gu,, Daejeon, South Korea
Chungbuk National University Hospital
Gaesin-dong, Cheongju Si Heungdeok-gu, North Chungcheong, South Korea
Countries
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Other Identifiers
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L-FMAU-402
Identifier Type: -
Identifier Source: org_study_id