Safety and Antiviral Activity Study of Clevudine 30 mg QD in Patient With Chronic HBV

NCT ID: NCT00313287

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2004-11-30

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.

Conditions

Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

clevudine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients who were between 18 and 60, inclusive.

2. Patients with HBV DNA ³1 x 106 copies/mL within 30 days of baseline.

3. 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).

4. Patients who were HBeAg positive.

5. 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.

6. Women of child bearing potential with a negative serum (β-HCG) pregnancy test taken within 14 days of starting therapy.

7. Patients who were able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria

1. Patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy.

2. Patients previously treated with lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection.

3. Previous treatment with interferon that had ended less than 6 months prior to the screening visit.

4. Patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.

5. Patients co-infected with HCV, HDV or HIV.

6. Patients with clinical evidence of liver mass or with alpha-fetoprotein > 50 ng/mL

7. Patients who were pregnant or breast-feeding.

8. 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)

9. Patients with a clinically relevant history of abuse of alcohol or drugs.

10. 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.

11. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• 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

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

Countries

South Korea

Other Identifiers

L-FMAU-301

Identifier Type: -

Identifier Source: org_study_id