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This multi-center, observational study will examine the clinical use and outcomes of pegylated interferon (PEG-IFN) alfa-2a and ribavirin combination (PEGASYS RBV) in participants with chronic hepatitis C (CHC). Study visits will be scheduled for baseline, 12, 24 and 48 weeks after baseline. An additional follow-up visit at week 72 will be required for participants with an HCV genotype other than 2 or 3. Quality of life data will be collected at baseline, and at each follow-up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegylated Interferon (PEG-IFN) alfa-2a and Ribavirin | Participants with hepatitis C who were to be treated with combination of pegylated interferon (PEG-IFN) alfa-2a and ribavirin, within 7 days of baseline, with ongoing management at investigator's discretion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated interferon (PEG-INF) alfa-2a | Drug | Pegylated interferon (PEG-IFN) alfa-2a will be administered as per investigator's discretion and will be in line with the current product monograph. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Sustained Virologic Response (SVR) | Up to Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Short Form Health Survey (SF-36) Physical Composite Score | Baseline, Week 12, 24, 48 and 72 | |
| Short Form Health Survey (SF-36) Mental Composite Score | Baseline, Week 12, 24, 48 and 72 | |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with hepatitis C, who were to be treated with combination of pegylated interferon (PEG-IFN) alfa-2a and ribavirin (PEGASYS RBV), within 7 days of baseline.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Calgary | Alberta | T2N 4N1 | Canada | |||
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| Ribavirin | Drug | Ribavirin will be administered as per investigator's discretion and will be in line with the current product monograph. |
|
|
| Percentage of Participants with Adverse Events of Special Interest Leading to Study Medication Discontinuation |
| Up to Week 72 |
| Percentage of Participants Who Utilized Resources | Baseline, Week 12, 24, 48 and 72 |
| Edmonton |
| Alberta |
| T5H 4B9 |
| Canada |
| Edmonton | Alberta | T6G 2C8 | Canada |
| Edmonton | Alberta | T6G2B7 | Canada |
| Abbotsford British Columbia | British Columbia | V2S 3N5 | Canada |
| Surrey | British Columbia | V3V 1Z1 | Canada |
| Vancouver | British Columbia | V5Z 1H2 | Canada |
| Vancouver | British Columbia | V5Z 3P1 | Canada |
| Vancouver | British Columbia | V6Z 2C7 | Canada |
| Vancouver | British Columbia | V6Z 2K5 | Canada |
| Vernon | British Columbia | V1T 1W9 | Canada |
| West Vancouver | British Columbia | V7S 1X1 | Canada |
| Winnipeg | Manitoba | R2W 5L4 | Canada |
| Barrie | Ontario | L4M 5G1 | Canada |
| Brampton | Ontario | L6V 1B4 | Canada |
| Downsview | Ontario | M3N 2V7 | Canada |
| Greater Sudbury | Ontario | P3E 1B8 | Canada |
| Hamilton | Ontario | L8L 2X2 | Canada |
| Kingston | Ontario | K7L 5G2 | Canada |
| London | Ontario | N6A 5A5 | Canada |
| London | Ontario | N6A 5R9 | Canada |
| London | Ontario | N6B 2L4 | Canada |
| Mississauga | Ontario | L5M 2V8 | Canada |
| Newmarket | Ontario | L3Y 2P6 | Canada |
| Oshawa | Ontario | L1G 2B9 | Canada |
| Oshawa | Ontario | L1J 2J9 | Canada |
| Ottawa | Ontario | K1H 8L6 | Canada |
| Ottawa | Ontario | K1Y 4E9 | Canada |
| Richmond Hill | Ontario | L4E 4L6 | Canada |
| Richmond Hill | Ontario | Canada |
| Thunder Bay | Ontario | P7B 6V4 | Canada |
| Toronto | Ontario | M5G 2C4 | Canada |
| Toronto | Ontario | M6H 3M1 | Canada |
| Windsor | Ontario | N8X 5A6 | Canada |
| Windsor | Ontario | N9A 1C9 | Canada |
| Montreal | Quebec | H1T 2M4 | Canada |
| Montreal | Quebec | H3A 1A1 | Canada |
| Montreal | Quebec | H4J 1C5 | Canada |
| Montreal | Quebec | J2X 4S7 | Canada |
| Québec | Quebec | G1L 3L5 | Canada |
| Québec | Quebec | G1R 1S9 | Canada |
| Québec | Quebec | G1R 2J6 | Canada |
| Québec | Quebec | QC G1S 4L8 | Canada |
| Saint-Charles-Borromée | Quebec | J6E 2C3 | Canada |
| Regina | Saskatchewan | S4P 4V6 | Canada |
| Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| 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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