NCT01264107
Completed
Not Applicable
An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine
Bukwang Pharmaceutical1 site in 1 country37 target enrollmentApril 2009
ConditionsChronic Hepatitis B
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Hepatitis B
- Sponsor
- Bukwang Pharmaceutical
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Proportion of patients with sustained antiviral activity effect
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients is currently clevudine treatment.
- •Patients with HBV DNA \< 300 cpoies/mL and ALT normal Showing Muscle-related Symptom Who received Clevudine
- •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.
- •Patient is pregnant or breast-feeding.
- •Patient has a significant gastrointestinal, renal, decompensated liver, bronchopulmonary, neurological, cardiac, oncologic(except HCC)or allergic disease.
- •Patient, in the opinion of the investigator, unsuitable for the study.
- •Showing Muscle-related Symptom who any other evidence.
Outcomes
Primary Outcomes
Proportion of patients with sustained antiviral activity effect
Time Frame: at week 48
Secondary Outcomes
- The change of sAg(at week 48)
- Proportion of sAg loss(at week 48)
- The change of HBV DNA form the baseline(at week 48)
- Proportion of patients with ALT normalization(at week 48)
- Proportion of HBeAg loss/seroconversion(at week 48)
Study Sites (1)
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