Safety and Efficacy Study of Clevudine Compared With Clevudine and Vaccine in Patient With HBeAg(+) Chronic HBV
Phase IV Study to Evaluate the Safety and Efficacy of Clevudine Compared With Clevudine and Vaccine in Patients Chronically Infected With HBV, HBeAg(+)
1 other identifier
interventional
70
1 country
7
Brief Summary
A randomized, parallel, multicenter, active-controlled with 48 weeks of treatment period. Patients will be randomized to receive clevudine alone for 48 weeks or clevudine for 24 weeks followed by 24 weeks of clevudine in addition to monthly HBV vaccination.The purpose of this study is to investigate efficacy of combination of clevudine and HBV vaccine over clevudine alone in patients with chronic hepatitis B infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 12, 2007
CompletedFirst Posted
Study publicly available on registry
July 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedDecember 22, 2010
August 1, 2009
3.2 years
July 12, 2007
December 21, 2010
Conditions
Outcome Measures
Primary Outcomes (2)
Antiviral Activity: Proportion of patients with HBeAg loss
Screening, Day1(predose), every 4 weeks during treatment period(48weeks)
Safety Endpoints:Laboratory tests, Adverse Events, Vital signs, ECG
Screening, Day1(predose), every 4 weeks during treatment period(48weeks), ECG: screening, Week48
Secondary Outcomes (2)
Proportion of patients with HBV DNA below LOD, Biochemical improvement, Proportion of patients with seroconversion
Screening, Day1(predose), every 4 weeks during treatment period(48weeks)
Immunological endpoints: Alterations in immunological parameters before, after therapy, particularly with regards to the proliferative a
Day1(predose), Week 8, 16, 24, 28, 32, 40 and 48
Interventions
Eligibility Criteria
You may qualify if:
- Patient is between 18 and 60
- Patient is HBV DNA positive with DNA levels ≥ 5 x 10(6) copies/mL within 30 days of baseline.
- Patient is documented to be HBsAg positive for \> 6 months. Patient is HBeAg positive.
- 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.
- Women of childbearing potential must have a negative urine (β-HCG) pregnancy test taken within 14 days of starting therapy.
- Patient is able to give written informed consent prior to study start and to comply with the study requirements.
You may not qualify if:
- Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
- Patients previously treated with interferon, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
- Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patient is coinfected with HCV, HDV or HIV.
- Patient with clinical evidence of decompensated liver disease or HCC
- ANA \> 1:160 and positive anti-smooth muscle antibody as evidence of autoimmune hepatitis
- Patient is pregnant or breast-feeding.
- 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.
- Patient has a clinically relevant history of abuse of alcohol or drugs.
- 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.
- Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heon Young Lee, MD. PhD.
Chungnam National University Hospital
- PRINCIPAL INVESTIGATOR
Hyeon Woong Yang, MD. PhD.
Eulji University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 12, 2007
First Posted
July 13, 2007
Study Start
May 1, 2007
Primary Completion
July 1, 2010
Last Updated
December 22, 2010
Record last verified: 2009-08