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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-003932-23 | EudraCT Number |
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This 3-arm study assessed the safety and efficacy of combination treatment with peginterferon alfa-2a + ribavirin in participants with chronic hepatitis C. Three groups of participants were studied; 1) those with elevated alanine transaminase (ALT) levels, 2) those with normal ALT levels, and 3) those with human immunodeficiency virus (HIV) co-infection. Participants with genotype 1, 4, 5 or 6 received peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) once weekly (qw) + ribavirin 1000-1200 milligrams (mg) orally (PO) daily (dependent on body weight) for 48 weeks. Those with genotype 2 or 3 received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 24 weeks, and all participants with HIV co-infection received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 48 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Participants with genotype 1, 4, 5 or 6 received peginterferon alfa-2a 180 mcg SC qw + ribavirin 1000-1200 mg PO daily (dependent on body weight) for 48 weeks. |
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| Group B | Experimental | Participants with genotype 2 or 3 received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 24 weeks. |
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| Group C | Experimental | Participants with HIV co-infection received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2a | Drug | Peginterferon alfa-2a was administered at a dose of 180 mcg SC weekly for 48 weeks to participants with genotype 1, 4, 5, 6 and to participants with HIV co-infection, or for 24 weeks to participants with genotype 2 and 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virological Response | Sustained virological response is defined as having no hepatitis C (HCV) virus detectable in the blood 24 weeks after end of treatment. | Up to 72 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With End-of-Treatment Virological Response | End-of-treatment virological response is defined as having no HCV virus detectable in the blood immediately after end of treatment. | Up to 48 weeks |
| Percentage of Participants With Early-Treatment Virological 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 |
|---|---|---|---|---|---|---|
| Beroun | Czechia | |||||
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| Ribavirin | Drug | Ribavirin was administered at a dose of 1000-1200 mg PO daily for 48 weeks to participants with genotype 1, 4, 5, 6 or 800 mg PO daily for 24 weeks to participants with genotype 2 and 3. |
|
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Early-treatment virological response is defined as having no HCV virus detectable in the blood or a 2-log (100-fold) decrease in HCV virus concentration in the blood after 12 weeks of study treatment. |
| Up to 12 weeks |
| Percentage of Participants With Adverse Events | An adverse event is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsen during the study are reported as adverse events. | Up to 72 weeks |
| Brno |
| 62500 |
| Czechia |
| Chomutov | Czechia |
| Česká Lípa | Czechia |
| České Budějovice | 370 87 | Czechia |
| Děčín | 0 | Czechia |
| Havířov | Czechia |
| Havlíčkův Brod | Czechia |
| Hradec Králové | 500 12 | Czechia |
| Hradec Králové | Czechia |
| Jablonec/nisou | 466 60 | Czechia |
| Jihlava | Czechia |
| Karlovy Vary | Czechia |
| Kolín | Czechia |
| Liberec | Czechia |
| Mělník | Czechia |
| Most | Czechia |
| Olomouc | Czechia |
| Opava | Czechia |
| Ostrava | 708 52 | Czechia |
| Pardubice | Czechia |
| Prague | 00000 | Czechia |
| Prague | 128 08 | Czechia |
| Prague | 140 00 | Czechia |
| Prague | 180 01 | Czechia |
| Prague | Czechia |
| Prostějov | Czechia |
| Ústí nad Labem | Czechia |
| Banská Bystrica | 957 17 | Slovakia |
| Bratislava | 833 05 | Slovakia |
| Bratislava | 851 07 | Slovakia |
| Košice | 040 01 | Slovakia |
| Košice | 04001 | Slovakia |
| Martin | 036 59 | Slovakia |
| Trenčín | 911 07 | Slovakia |
| 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 |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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