- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00672867
A Pilot Study to Evaluate the Safety and Efficacy of Clevudine or Adefovir Patients With LC-B
December 17, 2014 updated by: Bukwang Pharmaceutical
A Open Randomized Clinical Trial Comparing the Efficacy and Safety of Clevudine 30mg Versus Adefovir 10mg in Patients With LC-B
The purpose of this study is to compare the safety and antiviral activity of Clevudine Versus Adefovir dipivoxil in patients with LC-B.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
102
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Samsung Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient is 18 years and older.
- 5 ≦ Child-Pugh score ≦ 12
- Patient is HBV DNA positive with DNA levels ≥ 1 x 10(4) copies/mL within 30 days of baseline.
- Patient is documented to be HBsAg positive for > 6 months.
- Patient is HBeAg positive or negative.
- Patient has ALT or AST levels which are in the range of > 1 x ULN and < 15 X ULN
- Patient with liver cirrhosis diagnosed by imaging study within 1 year or clinical evidence of portal hypertension
- Life expectancy of at least 12 months
- Female patient with a negative urine(Beta-HCG) pregnancy test taken within 14 days of starting therapy.
- 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.
- Previous treatment with interferon must have ended at least 6 months prior to the screening visit.
- Patients previously treated with clevudine, entecavir, lamivudine, adefovir, telbivudine or any other investigational nucleoside for HBV infection.
- Patient is coinfected with HCV, HDV or HIV.
- Patient with clinical evidence of hepatocellular carcinoma
- Patient has alpha-fetoprotein > 400ng/mL.
- Patient has Hemoglobin <8g/dL (Male), 7.5g/dL (Female) or WBC <1,500mm3 or Neutrophils <500/mm3 or Platelet count <30,000/mm3.
- 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.
- Patient has a clinically relevant history of abuse of alcohol or drugs.
- Patient with previous liver transplantation
- 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]
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Clevudine
|
30mg
Other Names:
|
Active Comparator: 2
Adefovir
|
10mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Proportion of patients with HBV DNA below 12 IU/mL by Real-Time PCR
|
Secondary Outcome Measures
Outcome Measure |
---|
The change of HBV DNA from the baseline.
|
Child-Pugh score improvement
|
MELD score improvement
|
Biochemical improvement
|
Proportion of patients with HBeAg loss and/or seroconversion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
May 2, 2008
First Submitted That Met QC Criteria
May 2, 2008
First Posted (Estimate)
May 6, 2008
Study Record Updates
Last Update Posted (Estimate)
December 18, 2014
Last Update Submitted That Met QC Criteria
December 17, 2014
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- L-FMAU-309
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patients With LC-B
-
Meir Medical CenterUnknownPatients With Normal ECG | Patients With Pathological ECGIsrael
-
Centre Hospitalier Universitaire DijonCompletedPatients Undergoing Cardiac Surgery | Patients With Coronary Artery Bypass Surgery With CECFrance
-
Rennes University HospitalTerminated
-
Centre Francois BaclesseRecruitingPatients With CancerFrance
-
Yonsei UniversityRecruitingPatients With DefibrillatorKorea, Republic of
-
Philogen S.p.A.TerminatedPatients With CancerItaly, United Kingdom
-
Hospices Civils de LyonRecruitingPatients With Diffuse Large B-cell Lymphoma Treated With CART-cellsFrance
-
Yonsei UniversityNot yet recruiting
-
Second Affiliated Hospital, School of Medicine,...Sir Run Run Shaw Hospital; Zhejiang Provincial People's HospitalActive, not recruitingCancer Patients With PICCChina
-
Centre Hospitalier Universitaire de NiceCompletedPatients With Pharmaceutical RecordFrance
Clinical Trials on Clevudine
-
Bukwang PharmaceuticalCompleted
-
Bukwang PharmaceuticalTerminatedHepatitis BKorea, Republic of
-
Bukwang PharmaceuticalTerminatedHepatitis BKorea, Republic of
-
Triangle PharmaceuticalsUnknownHepatitis BUnited States, Canada, China, France, Singapore
-
Bukwang PharmaceuticalCompletedChronic Hepatitis BKorea, Republic of
-
French National Agency for Research on AIDS and...Gilead Sciences; PharmassetTerminatedHBe Negative Chronic Hepatitis B | Hepatitis B Viral InfectionFrance
-
Bukwang PharmaceuticalCompletedHBeAg(+) Chronic Hepatitis BKorea, Republic of
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Bukwang PharmaceuticalCompleted
-
Bukwang PharmaceuticalCompletedChronic Hepatitis BKorea, Republic of