Safety and Antiviral Activity Study of Clevudine 30 mg QD in Patients With HBeAg(-) Chronic HBV
Study Details
Study Description
Brief Summary
The purpose of this study is to determine safety and efficacy of 30mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in chronic HBV infected patients with HBeAg negative
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Outcome Measures
Primary Outcome Measures
- Efficacy: []
- Antiviral activity (change from baseline in HBV DNA (log 10)) []
- Safety: []
- Laboratory tests []
- Adverse Events []
- Vital signs []
- ECG []
Secondary Outcome Measures
- Efficacy []
- Antiviral activity: proportion of patients with HBV DNA below the assay limit of detection (<4,700 copies/mL by Digene Hybrid Capture II assay) []
- Biochemical improvement (e.g. ALT normalization ) []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who were between 18 and 60, inclusive
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Patients with HBV DNA levels 1 x 105 copies/mL within 30 days of baseline.
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Patients who were documented to be HBsAg positive for > 6 months (documentation of positive HBsAg for the previous 6 months included previous laboratory reports showing HBsAg positive at least 6 month ago OR lab results showing IgM anti-HBc negative and IgG anti-HBc positive at screening).
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Patients who were HBeAg negative and HBeAb positive.
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Patients with ALT levels which were in the range of ≥1.2 and < 15 times the upper limit of normal (ULN) 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.
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Women of childbearing potential with a negative serum (β-HCG) pregnancy test taken within 14 days of starting therapy.
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Patients who were able to give written informed consent prior to study start and to comply with the study requirements.
Exclusion Criteria:
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Patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy.
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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.
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Patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.
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Patients coinfected with HCV, HDV or HIV.
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Patients with clinical evidence of liver mass or with alfa-fetoprotein > 50 ng/mL
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Patients who were pregnant or breast-feeding.
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Patients who were unwilling to use an "effective" method of contraception during the treatment period 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)
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Patients with a clinically relevant history of abuse of alcohol or drugs.
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Patients with a significant gastrointestinal, renal, hepatic (decompensated), broncho-pulmonary, biliary diseases except asymptomatic GB stone, neurological, cardiovascular, oncologic or allergic disease. The patient with a benign tumor was excluded if judged by an investigator that the continuation of study would be interfered by benign tumor.
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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]
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | St. Mercy's Hospital | Bupyoung-dong | Bupyoung-gu, Incheon | Korea, Republic of | |
2 | Kangbuk Samsung Hospital | Pyoung-dong | Chongro-gu, Seoul | Korea, Republic of | |
3 | Keimyumg University Dongsan Medical Center | Jung-gu | Daegu | Korea, Republic of | |
4 | Chonnam National University Hospital | Hak-1-dong | Dong-gu, Gwangju-si | Korea, Republic of | |
5 | Korea University Guro Hospital | Seoul City | Guro-gu | Korea, Republic of | |
6 | Wonkwang University Hospital | Iksan-City | Jeonbuk | Korea, Republic of | |
7 | Chonbuk National University Hospital | Jeonju-city | Jeonbuk | Korea, Republic of | |
8 | Seoul National University Hospital | Seoul | Jongno-Gu | Korea, Republic of | |
9 | Inha University Hospital | Sinhung-dong | Jung-gu, Incheon | Korea, Republic of | |
10 | Yongdong Severance Hospital | Dogok-dong | Kangnam-gu, Seoul | Korea, Republic of | |
11 | Seoul Asan Medical Center | Pungnap-dong | Kangnam-gu, Seoul | Korea, Republic of | |
12 | National Cancer Center | Ilsan-gu | Kyounggi-do | Korea, Republic of | |
13 | St. Holly Family Mary's Hospital | Puch'onae | Kyounggi-do | Korea, Republic of | |
14 | Pochon CHA University Hospital | Seongnam-gu | Kyounggi-do | Korea, Republic of | |
15 | Yeungnam University Medical Center | Dae myoung-dong | Nam-gu, Taegu | Korea, Republic of | |
16 | Gil Medical Center | Incheon | Namdong-Gu | Korea, Republic of | |
17 | Nowon Eulji Hospital | Hagye 1-dong | Nowon-gu, Seoul | Korea, Republic of | |
18 | St. Vincent's Hospital | Ji-dong | Paldal-gu, Suwon | Korea, Republic of | |
19 | Pusan Paik Hospital | Gaegeum-dong | Pusan | Korea, Republic of | |
20 | Pusan National University Hospital | Ami-dong | Seo-gu, Pusan | Korea, Republic of | |
21 | Kosin Medical Center | Amnam-dong | Seo-gu, Pusan | Korea, Republic of | |
22 | KangNam St. Mary's Hospital | Banpo-dong | Seocho-gu, Seoul | Korea, Republic of | |
23 | Severance Hospital | Shinchon- dong | Seodaemun-gu, Seoul | Korea, Republic of | |
24 | Seoul Paik Hospital | Jeo-dong | Seoul | Korea, Republic of | |
25 | Samsung Medical Center | Ilwon-dong | Songpa-gu, Seoul | Korea, Republic of | |
26 | Korea University Anam Hospital | Anam-dong | Sungbuk-ku, Seoul | Korea, Republic of | |
27 | Ehwa Womans University Mokdong Hospital | Mokdong | Yangcheon-gu, Seoul | Korea, Republic of | |
28 | Kangnam Sacred Heart Hospital | Daelim-dong | Yongdeungpo-gu, Seoul | Korea, Republic of | |
29 | Soon Chun Hyang University Hospital | Hannam-dong | Yongsan-gu, Seoul | Korea, Republic of | |
30 | St. Mary's Hospital | Seoul | Yungdungpo-Gu | Korea, Republic of |
Sponsors and Collaborators
- Bukwang Pharmaceutical
Investigators
- Principal Investigator: Hyo-Suk Lee, MD. PhD, Seoul National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- L-FMAU-302