Back to resultsA Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period
Primary Purpose
Chronic Hepatitis B
Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Clevudine
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B
Eligibility Criteria
Inclusion Criteria:
- Patient is 18 years and older.
- Patient is documented to be HBsAg positive for > 6 months and HBV DNA positive.
- Patient is HBeAg positive or negative.
- Patient has ALT levels ≥ 80 IU/L
- Patient who 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, cytotoxic or corticosteroid therapy.
- Patients previously treated with interferon within the previous 3 months.
- Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
- Patient is coinfected with HCV, HDV or HIV.
- Patient is pregnant or breast-feeding.
- Patient has a clinically relevant history of abuse of alcohol or drugs.
- Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.
- 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]
Sites / Locations
- Gangnam Severance Hospital
Outcomes
Primary Outcome Measures
Proportion of patients with HBV DNA below the assay limit of detection
Secondary Outcome Measures
The change of HBV DNA from the baseline.
Proportion of patients with HBeAg loss and/or seroconversion.
Biochemical improvement (e.g. ALT normalization).
Proportion of sAg loss
Full Information
NCT ID
NCT01264094
First Posted
December 19, 2010
Last Updated
July 20, 2015
Sponsor
Bukwang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT01264094
Brief Title
A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period
Official Title
A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
Enrollment
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bukwang Pharmaceutical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Clevudine
Intervention Description
clevudine 30 mg qd
Primary Outcome Measure Information:
Title
Proportion of patients with HBV DNA below the assay limit of detection
Secondary Outcome Measure Information:
Title
The change of HBV DNA from the baseline.
Title
Proportion of patients with HBeAg loss and/or seroconversion.
Title
Biochemical improvement (e.g. ALT normalization).
Title
Proportion of sAg loss
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is 18 years and older.
Patient is documented to be HBsAg positive for > 6 months and HBV DNA positive.
Patient is HBeAg positive or negative.
Patient has ALT levels ≥ 80 IU/L
Patient who 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, cytotoxic or corticosteroid therapy.
Patients previously treated with interferon within the previous 3 months.
Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
Patient is coinfected with HCV, HDV or HIV.
Patient is pregnant or breast-feeding.
Patient has a clinically relevant history of abuse of alcohol or drugs.
Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.
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]
Facility Information:
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period
We'll reach out to this number within 24 hrs