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Safety and Antiviral Activity Study of Clevudine 30 mg QD in Patients With HBeAg(-) Chronic HBV

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ClinicalTrials.gov Identifier: NCT00313274
Recruitment Status : Terminated
First Posted : April 12, 2006
Last Update Posted : February 1, 2017
Sponsor:
Information provided by:
Bukwang Pharmaceutical

Brief Summary:
The purpose of this study is to determine safety and efficacy of 30mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in chronic HBV infected patients with HBeAg negative

Condition or disease Intervention/treatment Phase
Hepatitis B Drug: Clevudine Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Parallel, Placebo-Controlled Phase III Study to Evaluate the Safety and Antiviral Activity of Clevudine (L-FMAU) 30 mg QD in Patients With HBeAg Negative Chronic Hepatitis B
Study Start Date : July 2003
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Efficacy:
  2. Antiviral activity (change from baseline in HBV DNA (log 10))
  3. Safety:
  4. Laboratory tests
  5. Adverse Events
  6. Vital signs
  7. ECG

Secondary Outcome Measures :
  1. Efficacy
  2. Antiviral activity: proportion of patients with HBV DNA below the assay limit of detection (<4,700 copies/mL by Digene Hybrid Capture II assay)
  3. Biochemical improvement (e.g. ALT normalization )


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who were between 18 and 60, inclusive
  2. Patients with HBV DNA levels 1 x 105 copies/mL within 30 days of baseline.
  3. Patients who were documented to be HBsAg positive for > 6 months (documentation of positive HBsAg for the previous 6 months included previous laboratory reports showing HBsAg positive at least 6 month ago OR lab results showing IgM anti-HBc negative and IgG anti-HBc positive at screening).
  4. Patients who were HBeAg negative and HBeAb positive.
  5. Patients with ALT levels which were in the range of ≥1.2 and < 15 times the upper limit of normal (ULN) and 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.
  6. Women of childbearing 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. Previous treatment with interferon that had ended less than 6 months prior to the screening visit.
  3. Patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.
  4. Patients coinfected with HCV, HDV or HIV.
  5. Patients with clinical evidence of liver mass or with alfa-fetoprotein > 50 ng/mL
  6. Patients who were pregnant or breast-feeding.
  7. Patients who were unwilling to use an "effective" method of contraception during the treatment period 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)
  8. Patients with a clinically relevant history of abuse of alcohol or drugs.
  9. Patients with a significant gastrointestinal, renal, hepatic (decompensated), broncho-pulmonary, biliary diseases except asymptomatic GB stone, neurological, cardiovascular, oncologic or allergic disease. The patient with a benign tumor was excluded if judged by an investigator that the continuation of study would be interfered by benign tumor.
  10. 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]


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313274


Locations
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Korea, Republic of
St. Mercy's Hospital
Bupyoung-dong, Bupyoung-gu, Incheon, Korea, Republic of
Kangbuk Samsung Hospital
Pyoung-dong, Chongro-gu, Seoul, 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
Korea University Guro Hospital
Seoul City, Guro-gu, Korea, Republic of
Wonkwang University Hospital
Iksan-City, Jeonbuk, Korea, Republic of
Chonbuk National University Hospital
Jeonju-city, Jeonbuk, Korea, Republic of
Seoul National University Hospital
Seoul, Jongno-Gu, Korea, Republic of
Inha University Hospital
Sinhung-dong, Jung-gu, Incheon, Korea, Republic of
Yongdong Severance Hospital
Dogok-dong, Kangnam-gu, Seoul, Korea, Republic of
Seoul Asan Medical Center
Pungnap-dong, Kangnam-gu, Seoul, Korea, Republic of
National Cancer Center
Ilsan-gu, Kyounggi-do, Korea, Republic of
St. Holly Family Mary's Hospital
Puch'onae, Kyounggi-do, Korea, Republic of
Pochon CHA University Hospital
Seongnam-gu, Kyounggi-do, Korea, Republic of
Yeungnam University Medical Center
Dae myoung-dong, Nam-gu, Taegu, Korea, Republic of
Gil Medical Center
Incheon, Namdong-Gu, Korea, Republic of
Nowon Eulji Hospital
Hagye 1-dong, Nowon-gu, Seoul, Korea, Republic of
St. Vincent's Hospital
Ji-dong, Paldal-gu, Suwon, Korea, Republic of
Pusan Paik Hospital
Gaegeum-dong, Pusan, 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
KangNam St. Mary's Hospital
Banpo-dong, Seocho-gu, Seoul, Korea, Republic of
Severance Hospital
Shinchon- dong, Seodaemun-gu, Seoul, Korea, Republic of
Seoul Paik Hospital
Jeo-dong, Seoul, Korea, Republic of
Samsung Medical Center
Ilwon-dong, Songpa-gu, Seoul, Korea, Republic of
Korea University Anam Hospital
Anam-dong, Sungbuk-ku, Seoul, Korea, Republic of
Ehwa Womans University Mokdong Hospital
Mokdong, Yangcheon-gu, Seoul, Korea, Republic of
Kangnam Sacred Heart Hospital
Daelim-dong, Yongdeungpo-gu, Seoul, Korea, Republic of
Soon Chun Hyang University Hospital
Hannam-dong, Yongsan-gu, Seoul, Korea, Republic of
St. Mary's Hospital
Seoul, Yungdungpo-Gu, Korea, Republic of
Sponsors and Collaborators
Bukwang Pharmaceutical
Investigators
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Principal Investigator: Hyo-Suk Lee, MD. PhD Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00313274     History of Changes
Other Study ID Numbers: L-FMAU-302
First Posted: April 12, 2006    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: April 2006
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Clevudine
Anti-Infective Agents