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TERMINATEDPHASE2

Safety and Efficacy Study of Retreated Clevudine in Chronic HBV Patients Who Received Clevudine in L-FMAU-201

An Open-Label, Phase II Study to Evaluate Safety, Tolerability, Antiviral Activity and Biochemical and Immunological Responses of Retreated Clevudine in Chronic Hepatitis B Patients Who Received Clevudine in L-FMAU-201

NCT00362700•Bukwang Pharmaceutical

View on ClinicalTrials.gov

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

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients who received clevudine in L-FMAU-201 clinical trial (phase IIb)
•2. Female of childbearing potential must have a negative serum ( b-HCG) pregnancy test within 14 days of starting therapy.
•3. Patient is able to give written informed consent prior to study start and to comply with the study requirements.
•4. 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 Criteria

•1. HBV DNA negative (\< 4,700 copies/mL) consistently at the last 2 visit (at least 2 consecutive visits, at one month interval)
•2. Patient is currently receiving antiviral immunomodulatory or corticosteroid therapy.
•3. Patients previously treated with lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection after cessation of treatment in L-FMAU-201 study.
•4. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
•5. Patient is coinfected with HCV, HDV or HIV.
•6. 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.
•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.
+2 more criteria

Locations (7)

Korea University Guro Hospital

Seoul, Guro-gu, South Korea

Seoul National University Hospital

Seoul, Jongno-Gu, South Korea

Yongdong Severance Hospital

Dogok-dong, Kangnam-gu, Seoul, South Korea

Samsung Medical Center

Ilwon-dong, Songpa-gu, Seoul, South Korea

Ehwa Womans University Mokdong Hospital

Mok-dong, Yangcheon-gu, Seoul, South Korea

Seoul Asan Medical Center

Pungnap-dong, Kangnam-gu, Seoul, South Korea

Asan Medical Center

P’ungnabi-dong, Songpa-Gu, Seoul, South Korea

Key Dates

Start Date

July 1, 2003

Completion Date

October 1, 2005

Last Updated

February 1, 2017

Enrollment

Estimated participants

Conditions

Hepatitis B

Interventions

Clevudine

DRUG

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

NCT07024641

Hepatitis B Virus Infection

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 1, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy Study of Retreated Clevudine in Chronic HBV Patients Who Received Clevudine in L-FMAU-201

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

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