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

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

Study Overview

• Status: Terminated
• Conditions: Hepatitis B
• Intervention / Treatment: Drug: Clevudine

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daechon
    • Daesa-dong, Jung-gu, Daechon, Korea, Republic of
      • Chungnam National University Hospital
  • Daegu
    • Jung-gu, Daegu, Korea, Republic of
      • Kyungpook National University Medical Hospital
    • Jung-gu,, Daegu, Korea, Republic of
      • Keimyumg University Dongsan Medical Center
  • Guro-gu
    • Seoul, Guro-gu, Korea, Republic of
      • Korea University Guro Hospital
  • Gwangju-si
    • Hak-1-dong, Dong-gu, Gwangju-si, Korea, Republic of
      • Chonnam National University Hospital
  • Incheon
    • Bupyoung-dong, Bupyoung-gu, Incheon, Korea, Republic of
      • St. Mercy's Hospital
    • Sinhung-dong, Jung-gu, Incheon, Korea, Republic of
      • Inha University Hospital
  • Jeonbuk
    • Iksan-City, Jeonbuk, Korea, Republic of
      • Wonkwang University Hospital
    • Jeonju-city, Jeonbuk, Korea, Republic of
      • Chonbuk National University Hospital
  • Jongno-Gu
    • Seoul, Jongno-Gu, Korea, Republic of
      • Seoul National University Hospital
  • Kyounggi-do
    • Ilsan-gu, Kyounggi-do, Korea, Republic of
      • National Cancer Center
    • Puch'un, Kyounggi-do, Korea, Republic of
      • St. Holly Family Mary's Hospital
    • Seongnam-gu, Kyounggi-do, Korea, Republic of
      • Pochon CHA University Hospital
  • Namdong-Gu
    • Incheon, Namdong-Gu, Korea, Republic of
      • Gil Medical Center
  • Pusan
    • Ami-dong, Seo-gu, Pusan, Korea, Republic of
      • Pusan National University Hospital
    • Amnam-dong, Seo-gu, Pusan, Korea, Republic of
      • Kosin Medical Center
    • Gaegeum-dong, Pusan, Korea, Republic of
      • Pusan Paik Hospital
  • Seoul
    • Anam-dong, Sungbuk-ku, Seoul, Korea, Republic of
      • Korea University Anam Hospital
    • Banpo-dong, Seocho-gu, Seoul, Korea, Republic of
      • KangNam St. Mary's Hospital
    • Daelim-dong, Yongdeungpo-gu, Seoul, Korea, Republic of
      • KangNam Sacred Heart Hospital
    • Dogok-dong, Kangnam-gu, Seoul, Korea, Republic of
      • Yongdong Severance Hospital
    • Gongneung-dong, Nowon-gu, Seoul, Korea, Republic of
      • Korea Cancer Center Hospital
    • Hannam-dong, Yongsan-gu, Seoul, Korea, Republic of
      • Soon Chun Hyang University Hospital
    • Ilwon-dong, Songpa-gu, Seoul, Korea, Republic of
      • Samsung Medical Center
    • Jeo-dong, Seoul, Korea, Republic of
      • Seoul Paik Hospital
    • Mok-dong, Yangcheon-gu, Seoul, Korea, Republic of
      • Ehwa Womans University Mokdong Hospital
    • Pungnap-dong, Kangnam-gu, Seoul, Korea, Republic of
      • Seoul ASAN Medical Center
    • Pyoung-dong, Chongro-gu,, Seoul, Korea, Republic of
      • Kangbuk Samsung Hospital
    • Shinchon- dong, Seodaemun-gu, Seoul, Korea, Republic of
      • Severance Hospital
  • Suwon
    • Ji-dong,, Paldal-gu, Suwon, Korea, Republic of
      • St. Vincent's Hospital
  • Taegu
    • Daemyoung-dong, Nam-gu, Taegu, Korea, Republic of
      • Yeungnam University Medical Center
  • Yungdungpo-Gu
    • Seoul, Yungdungpo-Gu, Korea, Republic of
      • St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy:change from baseline in HBV DNA; Safety: clinically measured adverse events, abnormality of laboratory tests and abnormality of vital signs, ECG.

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Bukwang Pharmaceutical
• Investigators: Principal Investigator: Hyo-Suk Lee, MD. PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Study Completion: March 1, 2006

Study Registration Dates

• First Submitted: August 8, 2006
• First Submitted That Met QC Criteria: August 8, 2006
• First Posted (Estimate): August 10, 2006

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 30, 2017
• Last Verified: June 1, 2006

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis B; Hepatitis; Anti-Infective Agents; Antiviral Agents; Clevudine
• Other Study ID Numbers: L-FMAU-303