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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00558818
Other study ID # KOR-404
Secondary ID KOR-404
Status Completed
Phase Phase 4
First received November 14, 2007
Last updated July 24, 2012
Start date June 2007
Est. completion date September 2011

Study information

Verified date July 2012
Source Bukwang Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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 (ß-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]

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Clevudine
clevudine 30 mg qd

Locations

Country Name City State
Korea, Republic of KoreaUniversity Guro Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Bukwang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No
Secondary 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) Yes
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