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

Primary Purpose

Hepatitis B

Status
Completed
Phase
Phase 3
Locations
Hong Kong
Study Type
Interventional
Intervention
Clevudine
Sponsored by
Bukwang Pharmaceutical
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient is between 18 and 60, inclusive. Patient is HBV DNA positive with DNA levels at screening >= 3 x 1,000,000 copies/mL. Patient is documented to be HBsAg positive for > 6 months and HBeAg positive. Patient has AST and ALT levels which are >= 1 times and <= 10 times the upper limit of normal (x ULN). 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. Women of childbearing age must have a negative urine (b-HCG) pregnancy test before start of trial treatment. Patient is able to give written informed consent prior to study start and to comply with the study requirements. Exclusion Criteria: Patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy. Patients previously treated with lamivudine, lobucavir, adefovir, famciclovir, or any other investigational nucleoside for HBV infection. Previous treatment with interferon must have ended at least 6 months prior to the screening visit. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy. Patient is co-infected with HCV or HIV. Patient has evidence of decompensated cirrhosis or hepatocellular carcinoma (alpha fetoprotein). Patient is pregnant or breast-feeding. 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). Patient has a clinically relevant history of abuse of alcohol or drugs. Patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease. 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. 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. Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.

Sites / Locations

  • Alice Ho Miu Ling Nethersole Hospital
  • Queen Mary Hospital

Outcomes

Primary Outcome Measures

Efficacy: incident rate of the HBV DNA negativity (i.e. <300 copies/ml) by PCR
Safety: Laboratory tests, Adverse Events, Physical examination

Secondary Outcome Measures

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

Full Information

First Posted
August 8, 2006
Last Updated
July 24, 2012
Sponsor
Bukwang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00362635
Brief Title
Compare the Efficacy and Safety of 48-week Treatment With Clevudine 30mg Versus Lamivudine 100mg for CHB Infection
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Bukwang Pharmaceutical

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Clevudine
Primary Outcome Measure Information:
Title
Efficacy: incident rate of the HBV DNA negativity (i.e. <300 copies/ml) by PCR
Title
Safety: Laboratory tests, Adverse Events, Physical examination
Secondary Outcome Measure Information:
Title
Efficacy:
Title
Viral kinetics of HBV DNA suppression
Title
Viral dynamic study over the first 12 weeks to define the nature of the anti-viral effect of Clevudine compared to Lamivudine.
Title
Evaluation of the changes of ALT normalization rate and HBV serology over 48 weeks of treatment period
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is between 18 and 60, inclusive. Patient is HBV DNA positive with DNA levels at screening >= 3 x 1,000,000 copies/mL. Patient is documented to be HBsAg positive for > 6 months and HBeAg positive. Patient has AST and ALT levels which are >= 1 times and <= 10 times the upper limit of normal (x ULN). 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. Women of childbearing age must have a negative urine (b-HCG) pregnancy test before start of trial treatment. Patient is able to give written informed consent prior to study start and to comply with the study requirements. Exclusion Criteria: Patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy. Patients previously treated with lamivudine, lobucavir, adefovir, famciclovir, or any other investigational nucleoside for HBV infection. Previous treatment with interferon must have ended at least 6 months prior to the screening visit. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy. Patient is co-infected with HCV or HIV. Patient has evidence of decompensated cirrhosis or hepatocellular carcinoma (alpha fetoprotein). Patient is pregnant or breast-feeding. 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). Patient has a clinically relevant history of abuse of alcohol or drugs. Patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease. 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. 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. Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George KK Lau, M.D.
Organizational Affiliation
Queen Mary Hospital, Hong Kong
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nancy Leung, M.D.
Organizational Affiliation
Alice Ho Miu Ling Nethersole Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alice Ho Miu Ling Nethersole Hospital
City
Tai Po
State/Province
New Territories
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Road
Country
Hong Kong

12. IPD Sharing Statement

Links:
URL
http://www.hkclinicaltrials.com/
Description
Unique trial number : HKCTR-250

Learn more about this trial

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

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