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Compare the Efficacy and Safety of 48-week Treatment With Clevudine 30mg Versus Lamivudine 100mg for CHB Infection

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ClinicalTrials.gov Identifier: NCT00362635
Recruitment Status : Completed
First Posted : August 10, 2006
Last Update Posted : July 26, 2012
Sponsor:
Information provided by:
Bukwang Pharmaceutical

Tracking Information
First Submitted Date  ICMJE August 8, 2006
First Posted Date  ICMJE August 10, 2006
Last Update Posted Date July 26, 2012
Study Start Date  ICMJE August 2006
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2006)
  • Efficacy: incident rate of the HBV DNA negativity (i.e. <300 copies/ml) by PCR
  • Safety: Laboratory tests, Adverse Events, Physical examination
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00362635 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2008)
  • Efficacy:
  • Viral kinetics of HBV DNA suppression
  • Viral dynamic study over the first 12 weeks to define the nature of the anti-viral effect of Clevudine compared to Lamivudine.
  • Evaluation of the changes of ALT normalization rate and HBV serology over 48 weeks of treatment period
  • Evaluation of the proportion of patients with HBV DNA <300 copies/ml, median HBV DNA change from baseline(log10 copies/ml), the proportion of patients with normal ALT, and HBV serology over an additional 48 weeks of open label treatment
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2006)
  • Efficacy:
  • Viral kinetics of HBV DNA suppression
  • Viral dynamic study over the first 12 weeks to define the nature of the anti-viral effect of Clevudine compared to Lamivudine.
  • Tolerance of anti-viral response after the cessation of 48 weeks treatment period till week 72.
  • Viral rebound defined as HBV DNA more than 100,000 copies/ml with a rise in serum transaminase to 2X ULN at 24 weeks after end of treatment.
  • Evaluation of the changes of ALT normalization rate and HBV serology over 48 weeks treatment period.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Compare the Efficacy and Safety of 48-week Treatment With Clevudine 30mg Versus Lamivudine 100mg for CHB Infection
Official Title  ICMJE A Double-blinded and Randomised Study to Compare the Efficacy and Safety of 48-week Treatment With Clevudine 30 mg qd Versus Lamivudine 100 mg qd for Chronic Hepatitis B Infection
Brief Summary The purpose of this study is to compare the efficacy and safety of 48-week treatment with Clevudine 30 mg qd versus lamivudine 100 mg qd for chronic hepatitis B infection.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Hepatitis B
Intervention  ICMJE Drug: Clevudine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 8, 2006)
92
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient is between 18 and 60, inclusive.
  2. Patient is HBV DNA positive with DNA levels at screening >= 3 x 1,000,000 copies/mL.
  3. Patient is documented to be HBsAg positive for > 6 months and HBeAg positive.
  4. Patient has AST and ALT levels which are >= 1 times and <= 10 times the upper limit of normal (x ULN).
  5. Patient has bilirubin levels <= 1.5 x ULN or bilirubin levels > 1.5 x ULN with diagnosis of Gilbert's disease and conjugated bilirubin within normal limits.
  6. Women of childbearing age must have a negative urine (b-HCG) pregnancy test before start of trial treatment.
  7. 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 or corticosteroid therapy.
  2. Patients previously treated with lamivudine, lobucavir, adefovir, famciclovir, or any other investigational nucleoside for HBV infection.
  3. Previous treatment with interferon must have ended at least 6 months prior to the screening visit.
  4. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
  5. Patient is co-infected with HCV or HIV.
  6. Patient has evidence of decompensated cirrhosis or hepatocellular carcinoma (alpha fetoprotein).
  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. For males, condoms should be used. Females must be surgically sterile (via hysterectomy or bilateral tubal ligation), post-menopausal, or using at least a medically acceptable barrier method of contraception (i.e., IUD, barrier methods with spermicide or abstinence).
  9. Patient has a clinically relevant history of abuse of alcohol or drugs.
  10. Patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease.
  11. Subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to Screening Visit.
  12. Subjects who are taking any traditional Chinese medication, or has been taking any traditional Chinese medication within the last 2 weeks prior to Screening Visit.
  13. Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00362635
Other Study ID Numbers  ICMJE CLV-310
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Bukwang Pharmaceutical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: George KK Lau, M.D. Queen Mary Hospital, Hong Kong
Principal Investigator: Nancy Leung, M.D. Alice Ho Miu Ling Nethersole Hospital
PRS Account Bukwang Pharmaceutical
Verification Date July 2012

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