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The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of HM10660A in subjects with chronic hepatitis C(HCV).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort1 | Experimental | HM10660A SC once weekly |
|
| Cohort2 | Experimental | HM10660A SC once every 2 weeks |
|
| Cohort3 | Experimental | HM10660A SC once every 4 weeks |
|
| Cohort4 | Active Comparator | 180 mcg Pegasys SC once weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM10660A | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| HCV RNA Viral load | Through study week 32 | |
| Safety/tolerability | symptom-directed physical examination, Vital signs, Inspection of the Injection site, Complete Physical examination, 12-lead ECG, Hematology/coagulation | Through study week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Rapid virologic response (RVR) | Study Week 4 | |
| Early virologic response (EVR) | Study week 12 | |
| Sustained virologic response (SVR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanmi Clinical | Contact | clinical4@hanmi.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanmi Clinical | Recruiting | Estado de México | State of Mexico | Mexico |
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| Pegasys |
| Drug |
180 mcg Pegasys SC once weekly |
|
| Study week 24 |
| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
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