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

This study has been terminated.
Sponsor:
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00362505
First received: August 8, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted
  Purpose

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


Condition Intervention Phase
Hepatitis B
Drug: Clevudine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bukwang Pharmaceutical:

Primary Outcome Measures:
  • 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:
  • 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

Study Start Date: June 2004
Estimated Study Completion Date: March 2006
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362505

Locations
Korea, Republic of
Chungnam National University Hospital
Daesa-dong, Jung-gu, Daechon, Korea, Republic of
Kyungpook National University Medical Hospital
Jung-gu, Daegu, Korea, Republic of
Keimyumg University Dongsan Medical Center
Jung-gu,, Daegu, Korea, Republic of
Chonnam National University Hospital
Hak-1-dong, Dong-gu, Gwangju-si, Korea, Republic of
Gil Medical Center
1198 Guwol-dong, Namdong-Gu, Incheon, Korea, Republic of
St. Mercy’s Hospital
Bupyoung-dong, Bupyoung-gu, Incheon, Korea, Republic of
Inha University Hospital
Sinhung-dong, Jung-gu, Incheon, Korea, Republic of
Wonkwang University Hospital
Iksan-City, Jeonbuk, Korea, Republic of
Chonbuk National University Hospital
Jeonju-city, Jeonbuk, Korea, Republic of
St. Holly Family Mary’s Hospital
2 sosa-dong, Wonmi-Gu, Pucheon, Kyounggi-do, Korea, Republic of
National Cancer Center
Ilsan-gu, Kyounggi-do, Korea, Republic of
Pochon CHA University Hospital
Seongnam-gu, Kyounggi-do, Korea, Republic of
Pusan National University Hospital
Ami-dong, Seo-gu, Pusan, Korea, Republic of
Kosin Medical Center
Amnam-dong, Seo-gu, Pusan, Korea, Republic of
Pusan Paik Hospital
Gaegeum-dong, Pusan, Korea, Republic of
Seoul National University Hospital
28 Yeongeon-dong, Jongno-Gu, Seoul, Korea, Republic of
St. Mary’s Hospital
62 Yeouido, Yungdungpo-Gu, Seoul, Korea, Republic of
Korea University Guro Hospital
80 Guro-dong, Gro-gu, Seoul, Korea, Republic of
Korea University Anam Hospital
Anam-dong, Sungbuk-ku, Seoul, Korea, Republic of
KangNam St. Mary’s Hospital
Banpo-dong, Seocho-gu, Seoul, Korea, Republic of
Kangnam Sacred Heart Hospital
Daelim-dong, Yongdeungpo-gu, Seoul, Korea, Republic of
Yongdong Severance Hospital
Dogok-dong, Kangnam-gu, Seoul, Korea, Republic of
Korea Cancer Center Hospital
Gongneung-dong, Nowon-gu, Seoul, Korea, Republic of
Soon Chun Hyang University Hospital
Hannam-dong, Yongsan-gu, Seoul, Korea, Republic of
Samsung Medical Center
Ilwon-dong, Songpa-gu, Seoul, Korea, Republic of
Seoul Paik Hospital
Jeo-dong, Seoul, Korea, Republic of
Ehwa Womans University Mokdong Hospital
Mok-dong, Yangcheon-gu, Seoul, Korea, Republic of
Seoul Asan Medical Center
Pungnap-dong, Kangnam-gu, Seoul, Korea, Republic of
Kangbuk Samsung Hospital
Pyoung-dong, Chongro-gu,, Seoul, Korea, Republic of
Severance Hospital
Shinchon- dong, Seodaemun-gu, Seoul, Korea, Republic of
St. Vincent’s Hospital
Ji-dong,, Paldal-gu, Suwon, Korea, Republic of
Yeungnam University Medical Center
Daemyoung-dong, Nam-gu, Taegu, Korea, Republic of
Sponsors and Collaborators
Bukwang Pharmaceutical
Investigators
Principal Investigator: Hyo-Suk Lee, MD. PhD Seoul National University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00362505     History of Changes
Other Study ID Numbers: L-FMAU-303
Study First Received: August 8, 2006
Last Updated: August 8, 2006
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Clevudine
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014