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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-000198-22 | EudraCT Number |
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This multicenter, open-label, uncontrolled study will evaluate the efficacy and safety of increasing the dose of peginterferon alfa-2a (Pegasys) in participants with Genotype 1/4/5/6 CHC and an early non-response to a standard course of peginterferon alfa-2a plus ribavirin. The study will consist of screening (4 weeks), treatment (32 weeks), and follow-up (24 weeks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Experimental | Participants will receive 360 microgram (mcg) of Peginterferon Alfa-2a subcutaneous (SC) once a week plus ribavirin (1000 - 1200 milligram per day [mg/day] orally as a split dose in the morning and the evening based on the participant's body weight) for 32 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ribavirin | Drug |
|
| |
| peginterferon alfa-2a |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Virologic Response, as measured by ultrasensitive Roche HCV TaqMan Test | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Sustained Virologic Response (SVR), as measured by ultrasensitive Roche HCV TaqMan Test | Week 56 | |
| Percentage of Participants Achieving End-of-treatment Response, as measured by ultrasensitive Roche HCV TaqMan Test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp | 2018 | Belgium | ||||
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| Drug |
|
|
| Week 32 |
| Mean Log Change From Baseline to Week 2, 4, 8, 12, 32, and 56 in Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Viral Load | Baseline, Week 2, 4, 8, 12, 32, 56 |
| Number of Participants With Adverse Events and Serious Adverse | Baseline up to Week 56 |
| Antwerp |
| 2060 |
| Belgium |
| Bruges | 8000 | Belgium |
| Brussels | 1000 | Belgium |
| Brussels | 1020 | Belgium |
| Brussels | 1070 | Belgium |
| Brussels | 1090 | Belgium |
| Brussels | 1180 | Belgium |
| Brussels | 1190 | Belgium |
| Brussels | 1200 | Belgium |
| Charleroi | 6000 | Belgium |
| Edegem | 2650 | Belgium |
| Ghent | 9000 | Belgium |
| Gilly | 6060 | Belgium |
| Haine-Saint-Paul | 7100 | Belgium |
| Kortrijk | 8500 | Belgium |
| Leuven | 3000 | Belgium |
| Liège | 4000 | Belgium |
| Namur | 5000 | Belgium |
| Roeselare | 8800 | Belgium |
| Yvoir | 5530 | Belgium |
| 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 |
|---|---|
| D012254 | Ribavirin |
| C100416 | peginterferon alfa-2a |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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