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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003508-11 | EudraCT Number |
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The purpose of this study is to determine if 48 weeks of therapy with Peginterferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Peginterferon alfa-2a plus Ribavirin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon Lambda-1a + Ribavirin | Experimental | Peginterferon Lambda-1a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks |
|
| Peginterferon alfa-2a + Ribavirin | Active Comparator | Peginterferon alfa-2a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon Lambda-1a | Biological |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who develop treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, and/or neutropenia as defined by ANC < 750 mm3 and/or thrombocytopenia as defined by platelets < 50,000 mm3) in treatment-naive subjects |
| Up to 48 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with Sustained Virologic Response at Post-Treatment Follow-up Week 24 (SVR24), defined as Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < Lower Limit of Quantitation of Assay (LLOQ) | At Post-Treatment Follow-up Week 24 | |
| Proportion of subjects with Rapid Virologic Response (RVR) (HCV RNA not detected) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Hradec Králové | 500 05 | Czechia | |||
| Local Institution |
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| Ribavirin |
| Drug |
|
|
| Peginterferon alfa-2a | Biological |
|
|
| On treatment Week 4 (of an up to 48-week treatment period) |
| Proportion of subjects with on-treatment Serious Adverse Events (SAEs) through end of treatment | Up to 48 weeks of treatment |
| Proportion of subjects with dose reductions through end of treatment | Up to 48 weeks of treatment |
| Proportion of subjects who discontinue due to Adverse Events (AEs) through end of treatment | Up to 48 weeks of treatment |
| Proportion of subjects with on-treatment Interferon (IFN)-associated symptoms as determined by adverse event reporting | On-treatment IFN-associated symptoms are:
| Up to 48 weeks of treatment |
| Prague |
| 140 00 |
| Czechia |
| Local Institution | Ústí nad Labem | 400 01 | Czechia |
| Local Institution | Guadalajara | Jalisco | 44500 | Mexico |
| Local Institution | Guadalajara | Jalisco | 44650 | Mexico |
| Local Institution | Distrito Federal | Mexico City | 03720 | Mexico |
| Local Institution | Mexico City | Mexico City | 07760 | Mexico |
| Local Institution | México | State of Mexico | 06700 | Mexico |
| Local Institution | Chungcheongnam-do | 330-930 | South Korea |
| Local Institution | Daegu | 700-821 | South Korea |
| Local Institution | Gangwon-do | 200-704 | South Korea |
| Local Institution | Gyeonggi-do | 420-717 | South Korea |
| Local Institution | Gyeonggi-do | 463-707 | South Korea |
| Local Institution | Gyeongsangnam-do | 626-770 | South Korea |
| Local Institution | Incheon | 403-720 | South Korea |
| Local Institution | Seoul | 156-755 | South Korea |
| 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 |
| D012254 | Ribavirin |
| C100416 | peginterferon alfa-2a |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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