Clinical trial NCT00362505: Safety and Antiviral Activity of Clevudine in Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hepatitis B
Lead sponsor: Bukwang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2006-08-10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Patient is between 18 and 60, inclusive
2. Patients who have completed L-FMAU-301 or L-FMAU-302 clinical trial.
3. Patient is HBsAg positive at week 48 in L-FMAU-301 or L-FMAU-302.
4. 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.
5. Women of childbearing potential must have a negative serum (β-HCG) pregnancy test at screening.
6. Patient is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Patients with HBV DNA \< 4,700 copies/mL, ALT normalization and consecutive e seroconversion at week 40 and 48 in L-FMAU-301
2. Patients with HBV DNA \< 4,700 copies/mL and ALT normalization in L-FMAU-302
3. Patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
4. Patients previously treated with α-interferon, lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection.
5. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
6. Patient is coinfected with HCV, HDV or HIV.
7. Patient with clinical evidence of liver mass or hepatocellular carcinoma and α-Fetoprotein \> 50 ng/mL
8. Patient is pregnant or breast-feeding.
9. 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)
10. Patient has a clinically relevant history of abuse of alcohol or drugs.
11. 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.
12. Patient has creatinine clearance less than 60mL/min as estimated by the following formula:

(140-age in years) (body weight \[kg\])/(72)(serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]

13.Patient whom investigator consider is not suitable in this study

Primary outcomes:
measure: Efficacy:change from baseline in HBV DNA; Safety: clinically measured adverse events, abnormality of laboratory tests and abnormality of vital signs, ECG.
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Daesa-dong, Jung-gu
country: Korea, Republic of
facility: Chungnam National University Hospital
state: Daechon
city: Jung-gu,
country: Korea, Republic of
facility: Keimyumg University Dongsan Medical Center
state: Daegu
city: Jung-gu
country: Korea, Republic of
facility: Kyungpook National University Medical Hospital
state: Daegu
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Guro-gu
city: Hak-1-dong, Dong-gu
country: Korea, Republic of
facility: Chonnam National University Hospital
state: Gwangju-si
city: Bupyoung-dong, Bupyoung-gu
country: Korea, Republic of
facility: St. Mercy's Hospital
state: Incheon
city: Sinhung-dong, Jung-gu
country: Korea, Republic of
facility: Inha University Hospital
state: Incheon
city: Iksan-City
country: Korea, Republic of
facility: Wonkwang University Hospital
state: Jeonbuk
city: Jeonju-city
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeonbuk
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-Gu
city: Ilsan-gu
country: Korea, Republic of
facility: National Cancer Center
state: Kyounggi-do
city: Puch'un
country: Korea, Republic of
facility: St. Holly Family Mary's Hospital
state: Kyounggi-do
city: Seongnam-gu
country: Korea, Republic of
facility: Pochon CHA University Hospital
state: Kyounggi-do
city: Incheon
country: Korea, Republic of
facility: Gil Medical Center
state: Namdong-Gu
city: Ami-dong, Seo-gu
country: Korea, Republic of
facility: Pusan National University Hospital
state: Pusan
city: Amnam-dong, Seo-gu
country: Korea, Republic of
facility: Kosin Medical Center
state: Pusan
city: Gaegeum-dong
country: Korea, Republic of
facility: Pusan Paik Hospital
state: Pusan
city: Anam-dong, Sungbuk-ku
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seoul
city: Banpo-dong, Seocho-gu
country: Korea, Republic of
facility: KangNam St. Mary's Hospital
state: Seoul
city: Daelim-dong, Yongdeungpo-gu
country: Korea, Republic of
facility: Kangnam Sacred Heart Hospital
state: Seoul
city: Dogok-dong, Kangnam-gu
country: Korea, Republic of
facility: Yongdong Severance Hospital
state: Seoul
city: Gongneung-dong, Nowon-gu
country: Korea, Republic of
facility: Korea Cancer Center Hospital
state: Seoul
city: Hannam-dong, Yongsan-gu
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital
state: Seoul
city: Ilwon-dong, Songpa-gu
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul
city: Jeo-dong
country: Korea, Republic of
facility: Seoul Paik Hospital
state: Seoul
city: Mok-dong, Yangcheon-gu
country: Korea, Republic of
facility: Ehwa Womans University Mokdong Hospital
state: Seoul
city: Pungnap-dong, Kangnam-gu
country: Korea, Republic of
facility: Seoul Asan Medical Center
state: Seoul
city: Pyoung-dong, Chongro-gu,
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
state: Seoul
city: Shinchon- dong, Seodaemun-gu
country: Korea, Republic of
facility: Severance Hospital
state: Seoul
city: Ji-dong,, Paldal-gu
country: Korea, Republic of
facility: St. Vincent's Hospital
state: Suwon
city: Daemyoung-dong, Nam-gu
country: Korea, Republic of
facility: Yeungnam University Medical Center
state: Taegu
city: Seoul
country: Korea, Republic of
facility: St. Mary's Hospital
state: Yungdungpo-Gu
Study officials:
affiliation: Seoul National University Hospital
name: Hyo-Suk Lee, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References: