Long-Term Study With Clevudine

This study is currently recruiting participants.

Verified by Bukwang Pharmaceutical, November 2007

First Received: November 14, 2007 No Changes Posted

Sponsored by:	Bukwang Pharmaceutical
Information provided by:	Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00558818

Purpose

A open-labeled phase lV study with 96 weeks of treatment period. The purpose of this study is to investigate safety and efficacy of clevudine in patients chronically infected with hepatitis B virus, HBeAg positive or negative.

Condition	Intervention	Phase
Chronic Hepatitis B	Drug: Clevudine	Phase IV

MedlinePlus related topics: Hepatitis Hepatitis B

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase lV Study to Evaluate the Long-Term Safety and Efficacy of Clevudine in the Patients Chronically Infected With Hepatitis B Virus

Further study details as provided by Bukwang Pharmaceutical:

Primary Outcome Measures:

Proportion of patients with HBV DNA below the assay limit of detection by Real-time PCR [ Time Frame: Screening, day1,every 12 weeks during treatment period(96weeks) ]

Secondary Outcome Measures:

Antiviral activity : change from baseline in HBV DNA (log10 copies/mL)Biochemical improvement (e.g. ALT normalization)Proportion of patients with HBeAg loss and/or seroconversionClevudine-related mutation [ Time Frame: Screening, day1, every 12 weeks during treatment period(96 weeks) ]

Estimated Enrollment:	150
Study Start Date:	June 2007

Intervention Details:

clevudine 30 mg qd

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patient with DNA levels >=1 x 105 copies/mL within 30 days of baseline.
Patient is documented to be HBsAg positive for > 6 months.
Patient has ALT levels >=80 IU/L
Women of childbearing potential must have a negative urine (β-HCG) pregnancy test taken within 14 days of starting therapy.

Exclusion Criteria.

Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
Patients previously treated with interferon within the previous 6 months.
Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
Patient is coinfected with HCV, HDV or HIV.
Patient with clinical evidence of decompensated liver disease or hepatocellular carcinoma
Patient is pregnant or breast-feeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00558818

Contacts

Contact: Soon Ho Um, MD.PhD

82-2-828-8087

umsh@korea.ac.kr

Locations

Korea, Republic of
KoreaUniversity Guro Hospital	Recruiting
Seoul, Korea, Republic of
Contact: Kwan Soo Byun, MD.PhD 82-2-828-8087 winner0429@naver.com

Sponsors and Collaborators

Bukwang Pharmaceutical

More Information

No publications provided

Study ID Numbers:	KOR-404, KOR-404
Study First Received:	November 14, 2007
Last Updated:	November 14, 2007
ClinicalTrials.gov Identifier:	NCT00558818 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic
Hepatitis B, Chronic

2'-fluoro-5-methylarabinosyluracil
Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections
Antiviral Agents

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
Hepatitis, Chronic
Hepatitis, Viral, Human
Hepadnaviridae Infections
Antiviral Agents
Pharmacologic Actions
Hepatitis

Virus Diseases
Digestive System Diseases
Therapeutic Uses
Hepatitis B, Chronic
2'-fluoro-5-methylarabinosyluracil
Hepatitis B
DNA Virus Infections

ClinicalTrials.gov processed this record on May 07, 2009