Long-term Study With Clevudine

• Sponsor: Bukwang Pharmaceutical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00558818
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Duration (Months): 51
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Chronic Hepatitis B	Drug: Clevudine	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. 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 [Screening, day1, every 12 weeks during treatment period(96 weeks)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

• Patient with DNA levels >=1 x 10^5 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.

• 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 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]

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KoreaUniversity Guro Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Bukwang Pharmaceutical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00558818
• Other Study ID Numbers: KOR-404; KOR-404
• First Posted: Nov 15, 2007
• Last Update Posted: Jul 26, 2012
• Last Verified: Jul 1, 2012

• Additional relevant MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis; Clevudine

Study Results

No Results Posted as of Jul 26, 2012