Safety and Efficacy Study of Clevudine Compared With Clevudine and Vaccine in Patient With HBeAg(+) 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. Identifier: NCT00501124
Recruitment Status : Completed
First Posted : July 13, 2007
Last Update Posted : December 22, 2010
Information provided by:
Bukwang Pharmaceutical

Brief Summary:
A randomized, parallel, multicenter, active-controlled with 48 weeks of treatment period. Patients will be randomized to receive clevudine alone for 48 weeks or clevudine for 24 weeks followed by 24 weeks of clevudine in addition to monthly HBV vaccination.The purpose of this study is to investigate efficacy of combination of clevudine and HBV vaccine over clevudine alone in patients with chronic hepatitis B infection.

Condition or disease Intervention/treatment Phase
Hepatitis B Drug: Clevudine Biological: Purified hepatitis B surface antigen Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV Study to Evaluate the Safety and Efficacy of Clevudine Compared With Clevudine and Vaccine in Patients Chronically Infected With HBV, HBeAg(+)
Study Start Date : May 2007
Actual Primary Completion Date : July 2010

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Antiviral Activity: Proportion of patients with HBeAg loss [ Time Frame: Screening, Day1(predose), every 4 weeks during treatment period(48weeks) ]
  2. Safety Endpoints:Laboratory tests, Adverse Events, Vital signs, ECG [ Time Frame: Screening, Day1(predose), every 4 weeks during treatment period(48weeks), ECG: screening, Week48 ]

Secondary Outcome Measures :
  1. Proportion of patients with HBV DNA below LOD, Biochemical improvement, Proportion of patients with seroconversion [ Time Frame: Screening, Day1(predose), every 4 weeks during treatment period(48weeks) ]
  2. Immunological endpoints: Alterations in immunological parameters before, after therapy, particularly with regards to the proliferative a [ Time Frame: Day1(predose), Week 8, 16, 24, 28, 32, 40 and 48 ]

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

Inclusion Criteria:

  1. Patient is between 18 and 60
  2. Patient is HBV DNA positive with DNA levels ≥ 5 x 10(6) copies/mL within 30 days of baseline.
  3. Patient is documented to be HBsAg positive for > 6 months. Patient is HBeAg positive.
  4. Patient has ALT levels which are in the range of ≥2 x ULN/L at least 2 consecutive visits, at least one month apart 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.
  5. Women of childbearing potential must have a negative urine (β-HCG) pregnancy test taken within 14 days of starting therapy.
  6. Patient is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

  1. Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
  2. Patients previously treated with interferon, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
  3. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
  4. Patient is coinfected with HCV, HDV or HIV.
  5. Patient with clinical evidence of decompensated liver disease or HCC
  6. ANA > 1:160 and positive anti-smooth muscle antibody as evidence of autoimmune hepatitis
  7. Patient is pregnant or breast-feeding.
  8. 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.
  9. Patient has a clinically relevant history of abuse of alcohol or drugs.
  10. Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic or allergic disease or medical illness that in the investigator's opinion might interfere with therapy. The patient with a benign tumor, excluded if judged by an investigator that the continuation of study would be interfered by the tumor.
  11. 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]

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 identifier (NCT number): NCT00501124

Korea, Republic of
Chungbuk National University Hospital
Gaesin-dong, Cheongju Si Heungdeok-gu, Chungcheongbuk-Do, Korea, Republic of
Dankook University Hospital
Anseo-dong, Cheonan Si, Chungcheongnam-Do, Korea, Republic of
Soon Chun Hyang University Cheonan Hospital
Bongmyeong-dong, Cheonan Si, Chungcheongnam-Do, Korea, Republic of
The Catholic University of Korea, Daejeon St. Mary's Hospital
Daeheung-dong, Jung-gu, Daejeon, Korea, Republic of
Chungnam National University Hospital
Daesa-dong, Jung-gu, Daejeon, Korea, Republic of
Eulji University Hospital
Dunsan 2-dong, Seo-gu, Daejeon, Korea, Republic of
Konyang University Hospital
Gasuwon-dong, Seo-gu,, Daejeon, Korea, Republic of
Sponsors and Collaborators
Bukwang Pharmaceutical
Principal Investigator: Heon Young Lee, MD. PhD. Chungnam National University Hospital
Principal Investigator: Hyeon Woong Yang, MD. PhD. Eulji University Hospital

Responsible Party: HY Lee, Chungnam University Hospital Identifier: NCT00501124     History of Changes
Other Study ID Numbers: L-FMAU-402
First Posted: July 13, 2007    Key Record Dates
Last Update Posted: December 22, 2010
Last Verified: August 2009

Additional relevant MeSH terms:
Hepatitis B
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Antiviral Agents
Anti-Infective Agents