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Safety and Efficacy Study of Clevudine Compared With Clevudine and Vaccine in Patient With HBeAg(+) Chronic HBV

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ClinicalTrials.gov Identifier: NCT00501124
Recruitment Status : Completed
First Posted : July 13, 2007
Last Update Posted : December 22, 2010
Sponsor:
Information provided by:
Bukwang Pharmaceutical

July 12, 2007
July 13, 2007
December 22, 2010
May 2007
July 2010   (Final data collection date for primary outcome measure)
  • Antiviral Activity: Proportion of patients with HBeAg loss [ Time Frame: Screening, Day1(predose), every 4 weeks during treatment period(48weeks) ]
  • Safety Endpoints:Laboratory tests, Adverse Events, Vital signs, ECG [ Time Frame: Screening, Day1(predose), every 4 weeks during treatment period(48weeks), ECG: screening, Week48 ]
Same as current
Complete list of historical versions of study NCT00501124 on ClinicalTrials.gov Archive Site
  • 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) ]
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of Clevudine Compared With Clevudine and Vaccine in Patient With HBeAg(+) Chronic HBV
Phase IV Study to Evaluate the Safety and Efficacy of Clevudine Compared With Clevudine and Vaccine in Patients Chronically Infected With HBV, HBeAg(+)
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hepatitis B
  • Drug: Clevudine
  • Biological: Purified hepatitis B surface antigen
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
Same as current
Not Provided
July 2010   (Final data collection date for primary outcome measure)

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]
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00501124
L-FMAU-402
No
Not Provided
Not Provided
HY Lee, Chungnam University Hospital
Bukwang Pharmaceutical
Not Provided
Principal Investigator: Heon Young Lee, MD. PhD. Chungnam National University Hospital
Principal Investigator: Hyeon Woong Yang, MD. PhD. Eulji University Hospital
Bukwang Pharmaceutical
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP