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This is an open label, dose ranging, phase1a/1b clinical trial to study the safety, Pharmacokinetics and Pharmacodynamics of Peglamda 60, 120, 180 and 240 mcg in healthy volunteers and antiviral activity of once weekly Peglamda administration in combination with daily Ribavirin in Hepatitis C naive patients up to 4 weeks period. The objective of the study to establish safety, PK/PD data on healthy subjects and preliminary efficacy and safety in Hepatitis C naive patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon alfa 2a | Active Comparator | Peginterferon alfa 2a 180 mcg |
|
| Peginterferon Lambda | Experimental | Peginterferon Lambda 60,120,180 and 240 mcg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon lambda | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve (AUC 0-336) | 0, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 336 hours | |
| Percentage of Patients achieving Rapid Virological Response (RVR) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with incidence of adverse events | 15 days |
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Inclusion Criteria:
Phase 1a: The subjects who are willing to participate in Phase 1a study must meet ALL of the following inclusion criteria:
Phase 1b: Subjects willing to participate into the phase 1b study must meet ALL of the following inclusion criteria:
Exclusion Criteria:
Phase 1a: Subjects with at least 1 of the following exclusion criteria are considered ineligible to participate in Phase 1a study:
Phase 1b: Subjects with at least 1 of the following exclusion criteria are considered ineligible to participate in Phase 1b study:
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| Name | Affiliation | Role |
|---|---|---|
| Dr.Chinh Trong Nguyen, PhD | The Military 108 Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Military 108 Hospital | Hanoi | 10000 | Vietnam |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000600496 | peginterferon lambda-1a |
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