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Comparison of virological breakthrough/relapse rate after dose adjustments and sustained virological response rate will be assessed by the type of induction.
The purpose of this study is to compare pharmacokinetics by IFN assays and pharmacodynamics by patient's HCVRNA suppression of 360 mug peginterferon QW, 9 MU interferon daily or 4,5 MU interferon daily in combination with 180 mug peginterferon QW in the first 4 weeks of treatment. Comparison of virological breakthrough/relapse rate after dose adjustments and sustained virological response rate will be assessed by the type of induction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 360 PEG IFN | Active Comparator | 360 mug peginterferon alfa-2a QW |
|
| 9 MU + 180 PEG IFN | Active Comparator | 9 MU interferon daily in combination with 180 mug peginterferon QW in the first 4 weeks of treatment |
|
| 4,5 MU IFN + 180 PEG IFN | Active Comparator | 4,5 MU interferon daily in combination with 180 mug peginterferon QW in the first 4 weeks of treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2a | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare pharmacokinetics by IFN assays and pharmacodynamics by patient's HCV RNA suppression of 360 mug peginterferon alfa-2a QW, 9 MU interferon alfa-2a daily or 4,5 interferon alfa-2a daily in combination with 180 mug peginterferon alfa-2a QW | week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the virological breakthrough/relapse rate after dose adjustments (at 4,24,72) weeks. | week 4, 24 and 72 | |
| To compare the sustained virological response rate at 24 weeks after end of treatment. | week 24 follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rob J. de Knegt, MD, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Rotterdam | 3015 CE | Netherlands |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D000077190 | Interferon alpha-2 |
| D007438 | Introns |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D016898 | Interferon-alpha |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
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| Interferon alfa-2a | Drug |
|
|
| Ribavirin | Drug |
|
|
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D036341 |
| Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D021901 | DNA, Intergenic |
| D040481 | Genome Components |
| D016678 | Genome |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
| D040461 | Gene Components |
| D005796 | Genes |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |