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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01264094

Enrollment

200

Registered

2010-12-21

Start date

2009-11-30

Completion date

2015-06-30

Last updated

2015-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

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.

Interventions

DRUGClevudine

clevudine 30 mg qd

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patient is 18 years and older. 2. Patient is documented to be HBsAg positive for \> 6 months and HBV DNA positive. 3. Patient is HBeAg positive or negative. 4. Patient has ALT levels ≥ 80 IU/L 5. Patient who is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion criteria

1. Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy. 2. Patients previously treated with interferon within the previous 3 months. 3. Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection. 4. Patient is coinfected with HCV, HDV or HIV. 5. Patient is pregnant or breast-feeding. 6. Patient has a clinically relevant history of abuse of alcohol or drugs. 7. 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. 8. Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]

Design outcomes

Primary

Measure	Time frame
Proportion of patients with HBV DNA below the assay limit of detection	—

Secondary

Measure	Time frame
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	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026