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TERMINATEDPHASE3

Safety and Antiviral Activity of Clevudine in Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials

An Open-label, Phase III Clinical Trial to Evaluate the Safety and Antiviral Activity of Clevudine in Chronic Hepatitis B Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials

NCT00362505•Bukwang Pharmaceutical

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine safety and efficacy of clevudine 10 mg qd for 24 weeks after completion of 24-week treatment with clevudine 30 mg qd with 12 weeks follow-up period

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient is between 18 and 60, inclusive
•2. Patients who have completed L-FMAU-301 or L-FMAU-302 clinical trial.
•3. Patient is HBsAg positive at week 48 in L-FMAU-301 or L-FMAU-302.
•4. Patient has bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), a serum albumin level of at least 3.5 g/dL at week 48 in L-FMAU-301 or L-FMAU-302.
•5. Women of childbearing potential must have a negative serum (β-HCG) pregnancy test at screening.
•6. Patient is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria

•1. Patients with HBV DNA \< 4,700 copies/mL, ALT normalization and consecutive e seroconversion at week 40 and 48 in L-FMAU-301
•2. Patients with HBV DNA \< 4,700 copies/mL and ALT normalization in L-FMAU-302
•3. Patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
•4. Patients previously treated with α-interferon, lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection.
•5. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
•6. Patient is coinfected with HCV, HDV or HIV.
•7. Patient with clinical evidence of liver mass or hepatocellular carcinoma and α-Fetoprotein \> 50 ng/mL
•8. Patient is pregnant or breast-feeding.
•9. 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) or post-menopausal or using at least medically acceptable barrier method of contraception (i.e. IUD, barrier methods with spermicide or abstinence)
•10. Patient has a clinically relevant history of abuse of alcohol or drugs.
+4 more criteria

Locations (32)

Pusan National University Hospital

Ami-dong, Seo-gu, Busan, South Korea

Kosin Medical Center

Amnam-dong, Seo-gu, Busan, South Korea

Pusan Paik Hospital

Gaegeum-dong, Busan, South Korea

Chungnam National University Hospital

Daesa-dong, Jung-gu, Daechon, South Korea

Yeungnam University Medical Center

Daemyoung-dong, Nam-gu, Daegu, South Korea

Keimyumg University Dongsan Medical Center

Jung-gu,, Daegu, South Korea

Kyungpook National University Medical Hospital

Jung-gu, Daegu, South Korea

Korea University Guro Hospital

Seoul, Guro-gu, South Korea

Chonnam National University Hospital

Hak-1-dong, Dong-gu, Gwangju, South Korea

St. Mercy's Hospital

Bupyoung-dong, Bupyoung-gu, Incheon, South Korea

Key Dates

Start Date

June 1, 2004

Completion Date

March 1, 2006

Last Updated

February 1, 2017

Conditions

Hepatitis B

Interventions

Clevudine

DRUG

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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 Antiviral Activity of Clevudine in Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials

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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