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| ID | Type | Description | Link |
|---|---|---|---|
| CMC-403 |
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A study to evaluate the efficacy and safety of clevudine and peg-interferon in sequence compared with clevudine alone in the patients with HBeAg(+) chronic Hepatitis B or clevudine and peg-interferon sequential treatment in patients with chronic Hepatitis B who have HBeAg(+)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Clevudine 30mg |
|
| 2 | Active Comparator | Clevudine 30mg + peg-interferon 180mcg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clevudine | Drug | 30mg,QD |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| antiviral activity;Proportion of patients with HBV DNA below LOD(HBV DAN levels < 300 copies/mL) by real time PCR | At week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| antiviral activity;Proportion of patients with HBV DNA below LOD(HBV DAN levels < 300 copies/mL) by real time PCR | At week 72 | |
| antiviral activity: The change of HBV DNA from the baseline | Screening, Day1(predose), at week 12, 24, 36, 48, 60, 72 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee Chang Don, MD, PhD | The Catholic University of Korea, Uijeongbu St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uijeongbu St.Mary's Hospital | Uijeongbu-si | South Korea |
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| Clevudine + Peg-interferon |
| Drug |
30mg, QD(for 24 weeks) + 180mcg,QW(for 24 weeks) |
|
|
| ALT normalization rate | Screening, Day1(predose), at week 12, 24, 36, 48, 60, 72 |
| Proportion sustained complete response of patients with complete response | At week 72 |
| Immunological endpoints | Day1(predose), at week 24, 48, 72 |
| Proportion of patients with HBeAg loss/ HBeAg seroconversion | At week 48 |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C034935 | clevudine |
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