Chronic Hepatitis B
Conditions
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.
Interventions
None listed
Sponsors
Bukwang Pharmaceutical
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patients is currently clevudine treatment. 2. Patients with HBV DNA \< 300 cpoies/mL and ALT normal Showing Muscle-related Symptom Who received Clevudine 3. 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. Patient is pregnant or breast-feeding. 3. Patient has a significant gastrointestinal, renal, decompensated liver, bronchopulmonary, neurological, cardiac, oncologic(except HCC)or allergic disease. 4. Patient, in the opinion of the investigator, unsuitable for the study. 5. Showing Muscle-related Symptom who any other evidence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with sustained antiviral activity effect | at week 48 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | (log copies/mL) |
| Proportion of patients with ALT normalization | at week 48 | — |
| Proportion of HBeAg loss/seroconversion | at week 48 | — |
Countries
South Korea
Outcome results
None listed