A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period

Sponsor

Bukwang Pharmaceutical (Industry)

Overall Status

Terminated

CT.gov ID

NCT01264094

Collaborator

(none)

200

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period.

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period

Study Start Date :

Nov 1, 2009

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Jun 1, 2015

Outcome Measures

Primary Outcome Measures

Proportion of patients with HBV DNA below the assay limit of detection []

Secondary Outcome Measures

The change of HBV DNA from the baseline. []
Proportion of patients with HBeAg loss and/or seroconversion. []
Biochemical improvement (e.g. ALT normalization). []
Proportion of sAg loss []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient is 18 years and older.
Patient is documented to be HBsAg positive for > 6 months and HBV DNA positive.
Patient is HBeAg positive or negative.
Patient has ALT levels ≥ 80 IU/L
Patient who is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
Patients previously treated with interferon within the previous 3 months.
Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
Patient is coinfected with HCV, HDV or HIV.
Patient is pregnant or breast-feeding.
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]