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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00313287
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 30 mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in patients with chronic HBV.

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 180 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 30 mg QD in Patients Chronically Infected With Hepatitis B Virus
Study Start Date : June 2003
Study Completion Date : November 2004

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Efficacy:change from baseline in HBV DNA (log10) at Week 24
  2. Safety: clinically measured adverse events, abnormality of laboratory tests and abnormality of vital signs.

Secondary Outcome Measures :
  1. Efficacy:
  2. Proportion of patients with HBV DNA below the assay Limit of Detection
  3. Proportion of patients with HBeAg loss and/or seroconversion (HBeAg loss and HBeAb gain)
  4. Proportion of 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 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.


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): NCT00313287


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
Kyungpook National University Medical Hospital
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, Gro-gu, Korea, Republic of
Wonkwang University Hospital
Iksan-City, Jeonbuk, Korea, Republic of
Chonbuk National University Hospital
Jeonju-city, Jeonbuk, Korea, Republic of
Chungnam National University Hospital
Daesa-dong, Jung-gu, Daechon, 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
Pucheon, 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
Korea Cancer Center Hospital
Gongneung-dong, Nowon-gu, Seoul, 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
Mok-dong, 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
Gil Medical Center
Incheon, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Bukwang Pharmaceutical
Investigators
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Principal Investigator: Hyo-Suk Lee, MD. PhD Seoul National University Hospital

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ClinicalTrials.gov Identifier: NCT00313287     History of Changes
Other Study ID Numbers: L-FMAU-301
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