Safety and Antiviral Activity of Clevudine in Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials

NCT ID: NCT00362505

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2006-03-31

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

Conditions

Hepatitis B

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Clevudine

Intervention Type: DRUG

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bukwang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Principal Investigators

Hyo-Suk Lee, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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

Countries

South Korea

Other Identifiers

L-FMAU-303

Identifier Type: -

Identifier Source: org_study_id