Safety and Antiviral Activity Study of Clevudine 30 mg QD in Patient With Chronic HBV
A Double-Blind, Randomized, Parallel, Placebo-Controlled Phase III Study to Evaluate the Safety and Antiviral Activity of Clevudine 30 mg QD in Patients Chronically Infected With Hepatitis B Virus
1 other identifier
interventional
180
1 country
33
Brief Summary
The purpose of this study is to determine safety and efficacy of 30 mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in patients with chronic HBV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2003
33 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
June 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 11, 2006
CompletedFirst Posted
Study publicly available on registry
April 12, 2006
CompletedFebruary 1, 2017
April 1, 2006
April 11, 2006
January 30, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Efficacy:change from baseline in HBV DNA (log10) at Week 24
Safety: clinically measured adverse events, abnormality of laboratory tests and abnormality of vital signs.
Secondary Outcomes (4)
Efficacy:
Proportion of patients with HBV DNA below the assay Limit of Detection
Proportion of patients with HBeAg loss and/or seroconversion (HBeAg loss and HBeAb gain)
Proportion of ALT normalization
Interventions
Eligibility Criteria
You may qualify if:
- Patients who were between 18 and 60, inclusive.
- Patients with HBV DNA ³1 x 106 copies/mL within 30 days of baseline.
- Patients who were documented to be HBsAg positive for \> 6 months. (The documentation of positive HBsAg for the previous 6 months included previous laboratory reports of HBsAg positive or HBeAg positive at least 6 month ago or IgM anti-HBc negative and IgG anti-HBc positive at screening).
- Patients who were HBeAg positive.
- Patients with ALT levels which were in the range of ≥1.2 and \< 15 times of the upper limit of normal (x ULN) and bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), and a serum albumin level of at least 3.5 g/dL.
- Women of child bearing potential with a negative serum (β-HCG) pregnancy test taken within 14 days of starting therapy.
- Patients who were able to give written informed consent prior to study start and to comply with the study requirements.
You may not qualify if:
- Patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy.
- Patients previously treated with lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection.
- Previous treatment with interferon that had ended less than 6 months prior to the screening visit.
- Patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patients co-infected with HCV, HDV or HIV.
- Patients with clinical evidence of liver mass or with alpha-fetoprotein \> 50 ng/mL
- Patients who were pregnant or breast-feeding.
- Patients who were unwilling to use an "effective" method of contraception during the treatment and for up to 3 months after cessation of therapy. For males, condoms should be used. Females had to be surgically sterile (via hysterectomy or bilateral tubal ligation) or post-menopausal or using at least medically acceptable barrier method of contraception ( i.e. IUD, barrier methods with spermicide or abstinence)
- Patients with a clinically relevant history of abuse of alcohol or drugs.
- Patients with a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, biliary diseases except asymptomatic GB stone, neurological, cardiovascular, oncologic or allergic disease.
- The patients with a benign tumor were excluded if judged by an investigator that the continuation of study would be interfered by benign tumor.
- Patients with creatinine clearance less than 60mL/min as estimated by the following formula :
- (140-age in years) (body weight \[kg\]) (72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
- Patients who were found to have YMDD HBV DNA polymerase mutation at baseline were to be excluded from the overall efficacy evaluation and analyzed separately. They were to be included in the overall safety evaluation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
St. Mercy's Hospital
Bupyoung-dong, Bupyoung-gu, Incheon, South Korea
Pusan Paik Hospital
Gaegeum-dong, Busan, South Korea
Kangbuk Samsung Hospital
Pyoung-dong, Chongro-gu, Seoul, South Korea
Keimyumg University Dongsan Medical Center
Jung-gu, Daegu, South Korea
Kyungpook National University Medical Hospital
Jung-gu, Daegu, South Korea
Chonnam National University Hospital
Hak-1-dong, Dong-gu, Gwangju-si, South Korea
Korea University Guro Hospital
Seoul, Gro-gu, South Korea
Wonkwang University Hospital
Iksan, Jeollabuk-do, South Korea
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Chungnam National University Hospital
Daesadong, Jung-gu, Daechon, South Korea
Inha University Hospital
Sinhŭng-dong, Jung-gu, Incheon, South Korea
Seoul Asan Medical Center
Pungnap-dong, Kangnam-gu, Seoul, South Korea
Yongdong Severance Hospital
Togok-tong, Kangnam-gu, Seoul, South Korea
National Cancer Center
Ilsan-gu, Kyounggi-do, South Korea
St. Holly Family Mary's Hospital
Pucheon, Kyounggi-do, South Korea
Pochon CHA University Hospital
Seongnam-gu, Kyounggi-do, South Korea
Yeungnam University Medical Center
Dae Myoung-dong, Nam-gu, Taegu, South Korea
Korea Cancer Center Hospital
Gongneungdong, Nowon-gu, Seoul, South Korea
Nowon Eulji Hospital
Hagyeil-tong, Nowon-gu, Seoul, South Korea
St. Vincent's Hospital
Chi-dong, Paldal-gu, Suwon, South Korea
Pusan National University Hospital
Ami-dong, Seo-gu, Pusan, South Korea
Kosin Medical Center
Amnam-dong, Seo-gu, Pusan, South Korea
KangNam St. Mary's Hospital
Banpo-dong, Seocho-gu, Seoul, South Korea
Severance Hospital
Shinchon- Dong, Seodaemun-gu, Seoul, South Korea
Seoul Paik Hospital
Jeo-dong, Seoul, South Korea
Samsung Medical Center
Ilwon-dong, Songpa-gu, Seoul, South Korea
Korea University Anam Hospital
Anam-dong, Sungbuk-ku, Seoul, South Korea
Ehwa Womans University Mokdong Hospital
Mokdong, Yangcheon-gu, Seoul, South Korea
Kangnam Sacred Heart Hospital
Daelim-dong, Yongdeungpo-gu, Seoul, South Korea
Soon Chun Hyang University Hospital
Hannam-dong, Yongsan-gu, Seoul, South Korea
St. Mary's Hospital
Seoul, Yungdungpo-Gu, South Korea
Gil Medical Center
Incheon, South Korea
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyo-Suk Lee, MD. PhD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 11, 2006
First Posted
April 12, 2006
Study Start
June 1, 2003
Study Completion
November 1, 2004
Last Updated
February 1, 2017
Record last verified: 2006-04