Safety and Antiviral Activity of Clevudine in Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials
An Open-label, Phase III Clinical Trial to Evaluate the Safety and Antiviral Activity of Clevudine in Chronic Hepatitis B Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials
1 other identifier
interventional
N/A
1 country
32
Brief Summary
The purpose of this study is to determine safety and efficacy of clevudine 10 mg qd for 24 weeks after completion of 24-week treatment with clevudine 30 mg qd with 12 weeks follow-up period
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2004
32 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, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 8, 2006
CompletedFirst Posted
Study publicly available on registry
August 10, 2006
CompletedFebruary 1, 2017
June 1, 2006
August 8, 2006
January 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy:change from baseline in HBV DNA; Safety: clinically measured adverse events, abnormality of laboratory tests and abnormality of vital signs, ECG.
Secondary Outcomes (1)
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:
- Patient is between 18 and 60, inclusive
- Patients who have completed L-FMAU-301 or L-FMAU-302 clinical trial.
- Patient is HBsAg positive at week 48 in L-FMAU-301 or L-FMAU-302.
- Patient has 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 at week 48 in L-FMAU-301 or L-FMAU-302.
- Women of childbearing potential must have a negative serum (β-HCG) pregnancy test at screening.
- Patient is able to give written informed consent prior to study start and to comply with the study requirements.
You may not qualify if:
- Patients with HBV DNA \< 4,700 copies/mL, ALT normalization and consecutive e seroconversion at week 40 and 48 in L-FMAU-301
- Patients with HBV DNA \< 4,700 copies/mL and ALT normalization in L-FMAU-302
- Patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
- Patients previously treated with α-interferon, lamivudine, lobucavir, adefovir 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 liver mass or hepatocellular carcinoma and α-Fetoprotein \> 50 ng/mL
- 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. For males, condoms should be used. Females must 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)
- Patient has a clinically relevant history of abuse of alcohol or drugs.
- Patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, biliary diseases excluding asymptomic GB stone, neurological, cardiovascular, oncologic or allergic disease. The patient with a benign tumor except for liver mass, 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 \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
- Patient whom investigator consider is not suitable in this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Pusan National University Hospital
Ami-dong, Seo-gu, Busan, South Korea
Kosin Medical Center
Amnam-dong, Seo-gu, Busan, South Korea
Pusan Paik Hospital
Gaegeum-dong, Busan, South Korea
Chungnam National University Hospital
Daesa-dong, Jung-gu, Daechon, South Korea
Yeungnam University Medical Center
Daemyoung-dong, Nam-gu, Daegu, South Korea
Keimyumg University Dongsan Medical Center
Jung-gu,, Daegu, South Korea
Kyungpook National University Medical Hospital
Jung-gu, Daegu, South Korea
Korea University Guro Hospital
Seoul, Guro-gu, South Korea
Chonnam National University Hospital
Hak-1-dong, Dong-gu, Gwangju, South Korea
St. Mercy's Hospital
Bupyoung-dong, Bupyoung-gu, Incheon, South Korea
Inha University Hospital
Sinhung-dong, Jung-gu, Incheon, South Korea
Wonkwang University Hospital
Iksan, Jeollabuk-do, South Korea
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Seoul National University Hospital
Seoul, Jongno-Gu, South Korea
National Cancer Center
Ilsan-gu, Kyounggi-do, South Korea
St. Holly Family Mary's Hospital
Puch’un, Kyounggi-do, South Korea
Pochon CHA University Hospital
Seongnam-gu, Kyounggi-do, South Korea
Gil Medical Center
Incheon, Namdong-Gu, South Korea
Korea University Anam Hospital
Anam-dong, Sungbuk-ku, Seoul, South Korea
KangNam St. Mary's Hospital
Banpo-dong, Seocho-gu, Seoul, South Korea
Kangnam Sacred Heart Hospital
Daelim-dong, Yongdeungpo-gu, Seoul, South Korea
Yongdong Severance Hospital
Dogok-dong, Kangnam-gu, Seoul, South Korea
Korea Cancer Center Hospital
Gongneung-dong, Nowon-gu, Seoul, South Korea
Soon Chun Hyang University Hospital
Hannam-dong, Yongsan-gu, Seoul, South Korea
Samsung Medical Center
Ilwon-dong, Songpa-gu, Seoul, South Korea
Seoul Paik Hospital
Jeo-dong, Seoul, South Korea
Ehwa Womans University Mokdong Hospital
Mok-dong, Yangcheon-gu, Seoul, South Korea
Seoul Asan Medical Center
Pungnap-dong, Kangnam-gu, Seoul, South Korea
Kangbuk Samsung Hospital
Pyoung-dong, Chongro-gu,, Seoul, South Korea
Severance Hospital
Shinchon- Dong, Seodaemun-gu, Seoul, South Korea
St. Vincent's Hospital
Ji-dong,, Paldal-gu, Suwon, South Korea
St. Mary's Hospital
Seoul, Yungdungpo-Gu, 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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 8, 2006
First Posted
August 10, 2006
Study Start
June 1, 2004
Study Completion
March 1, 2006
Last Updated
February 1, 2017
Record last verified: 2006-06