Status:
TERMINATED
Safety and Efficacy Study of Retreated Clevudine in Chronic HBV Patients Who Received Clevudine in L-FMAU-201
Lead Sponsor:
Bukwang Pharmaceutical
Conditions:
Hepatitis B
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety and antiviral activity of Clevudine, when retreated to patients previously treated with Clevudine
Eligibility Criteria
Inclusion
- Patients who received clevudine in L-FMAU-201 clinical trial (phase IIb)
- Female of childbearing potential must have a negative serum ( b-HCG) pregnancy test within 14 days of starting therapy.
- Patient is able to give written informed consent prior to study start and to comply with the study requirements.
- Patients who met the following criteria after completion of the Week 48 visit were to have additional follow-up visits at Weeks 54 and 60: 1) had received no additional therapy since completion of 24-week treatment of clevudine and 2)experienced a \> 1 log10 decrease from baseline in HBV DNA at Week 48
Exclusion
- HBV DNA negative (\< 4,700 copies/mL) consistently at the last 2 visit (at least 2 consecutive visits, at one month interval)
- Patient is currently receiving antiviral immunomodulatory or corticosteroid therapy.
- Patients previously treated with lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection after cessation of treatment in L-FMAU-201 study.
- Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patient is coinfected with HCV, HDV or HIV.
- Patient with clinical evidence of cirrhosis or hepatocellular carcinoma (®-Fetoprotein) Evaluation will be based on alpha-fetoprotein primarily. If alpha-fetoprotein level is suggestive of cirrhosis or hepatocellular carcinoma, confirmation will be made with sonography etc.
- 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.
- Patient has creatinine clearance less than 60mL/min as estimated by the following formula:
- (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00362700
Start Date
July 1 2003
End Date
October 1 2005
Last Update
February 1 2017
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Korea University Guro Hospital
Seoul, Guro-gu, South Korea
2
Seoul National University Hospital
Seoul, Jongno-Gu, South Korea
3
Yongdong Severance Hospital
Dogok-dong, Kangnam-gu, Seoul, South Korea
4
Samsung Medical Center
Ilwon-dong, Songpa-gu, Seoul, South Korea