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In this randomized, cross-over, open label study the correlation of Pegasys (peginterferon alfa-2a) pharmacokinetics after intravenous (iv) and subcutaneous (sc) administration with viral load and viral kinetics will be investigated in patients with chronic hepatitis C genotype 1 who were non-responders to previous standard combination therapy with pegylated interferon and ribavirin. Patients will be randomized to receive either weekly or twice weekly Pegasys iv or sc for 2 weeks, crossing over to the other mode of administration after a washout period of 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A/B | Experimental |
| |
| C/D | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peginterferon alfa 2a [Pegasys] | Drug | sc weekly |
| |
| peginterferon alfa-2a [Pegasys] |
| Measure | Description | Time Frame |
|---|---|---|
| HCV RNA levels (IU/ml, COBAS TaqMan HCV Test) in correlation with area under the plasma concentration-time curve (AUC) after sc and iv administration | 11 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of predictors of response to i.v. treatment | 11 months | |
| Effect of waist to hip ratio on pharmacokinetics | 11 months | |
| Effect of waist to hip ratio on viral response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berlin | 10969 | Germany | ||||
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| Drug |
iv weekly |
|
| peginterferon alfa-2a [Pegasys] | Drug | sc twice weekly |
|
| peginterferon alfa-2a [Pegasys] | Drug | iv twice weekly |
|
| 11 months |
| Incidence of adverse events | 11 months |
| Frankfurt am Main |
| 60590 |
| Germany |
| Hamburg | 20099 | Germany |
| Hanover | 30625 | Germany |
| Leipzig | 04103 | Germany |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| 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 |
|---|---|
| C100416 | peginterferon alfa-2a |
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