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This observational study will assess factors leading to dose reductions/treatment discontinuations and the effect on sustained virological response in patients with chronic hepatitis C receiving a long-acting interferon (e.g. Pegasys/peginterferon alfa-2a) and ribavirin. Data will be collected from each patient for the duration of their treatment and for up to 6 months thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation between baseline patient characteristics and safety related dose reductions/treatment discontinuations of the long-acting interferon or ribavirin | 4 years | |
| Correlation between safety related dose reductions/treatment discontinuations and sustained virological response (SVR: defined as HCV RNA <50 IU/mL at 24 weeks after completion of treatment) | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of on-treatment factors and dose reduction/treatment discontinuation | 4 years | |
| Correlation between degree of dose reductions/treatment interruptions (percentage of actual exposure/treatment administrations in relation to target exposure) and SVR |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic hepatitis C receiving a long-acting interferon plus ribavirin
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elbasan | Albania | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27018988 | Derived | Foster GR, Coppola C, Derbala M, Ferenci P, Orlandini A, Reddy KR, Tallarico L, Shiffman ML, Ahlers S, Bakalos G, Hassanein T; GUARD-C Study Group. Impact of Safety-Related Dose Reductions or Discontinuations on Sustained Virologic Response in HCV-Infected Patients: Results from the GUARD-C Cohort. PLoS One. 2016 Mar 28;11(3):e0151703. doi: 10.1371/journal.pone.0151703. eCollection 2016. |
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| 4 years |
| Comparison of on-treatment virological response (rapid virological response, early virological response) in treatment-naïve and treatment experienced patients | 4 years |
| Safety: Incidence of adverse events | 4 years |
| Tirana |
| 1000 |
| Albania |
| Algiers | 16000 | Algeria |
| Bahrain | 28743 | Bahrain |
| Manama | 12 | Bahrain |
| Antwerp | 2018 | Belgium |
| 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 |
| Charleroi | B6000 | Belgium |
| Edegem | 2650 | Belgium |
| Genk | 3600 | Belgium |
| Gerrardsbergen | 9500 | Belgium |
| Ghent | 9000 | Belgium |
| Haine-Saint-Paul | 7100 | Belgium |
| Hasselt | 3500 | Belgium |
| Kortrijk | 8500 | Belgium |
| Leuven | 3000 | Belgium |
| Liège | 4000 | Belgium |
| Mont-godinne | 5530 | Belgium |
| Namur | 5000 | Belgium |
| Ostend | 8400 | Belgium |
| Roeselare | 8800 | Belgium |
| Seraing | 4100 | Belgium |
| Sijsele | 8340 | Belgium |
| Verviers | 4800 | Belgium |
| Banja Luka | 78000 | Bosnia and Herzegovina |
| Bihać | 77000 | Bosnia and Herzegovina |
| Mostar | 88000 | Bosnia and Herzegovina |
| Sarajevo | 71000 | Bosnia and Herzegovina |
| Tuzla | 75000 | Bosnia and Herzegovina |
| Zenica | 72000 | Bosnia and Herzegovina |
| Salvador | Estado de Bahia | 41110-170 | Brazil |
| Belo Horizonte | Minas Gerais | 31270-901 | Brazil |
| Uberaba | Minas Gerais | 38025-180 | Brazil |
| Nova Iguaçu | Rio de Janeiro | 26030-380 | Brazil |
| Rio de Janeiro | Rio de Janeiro | 20020-022 | Brazil |
| Rio de Janeiro | Rio de Janeiro | 20270-004 | Brazil |
| Botucatu | São Paulo | 18600-400 | Brazil |
| Campinas | São Paulo | 13026-210 | Brazil |
| Santo André | São Paulo | 09060-650 | Brazil |
| Santos | São Paulo | 11015470 | Brazil |
| São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| São Paulo | São Paulo | 04040-002 | Brazil |
| São Paulo | São Paulo | 04040-003 | Brazil |
| Sorocaba | São Paulo | 18047-600 | Brazil |
| Alexandria | Egypt |
| Cairo | 0 | Egypt |
| Tanta | 0 | Egypt |
| Alexandroupoli | 68100 | Greece |
| Athens | 10552 | Greece |
| Athens | 10676 | Greece |
| Athens | 115 27 | Greece |
| Athens | 11521 | Greece |
| Athens | 11522 | Greece |
| Athens | 11526 | Greece |
| Athens | 11527 | Greece |
| Athens | 14233 | Greece |
| Athens | 15121 | Greece |
| Ioannina | 455 00 | Greece |
| Pátrai | 265 04 | Greece |
| Piraeus | 18454 | Greece |
| Piraeus | 18536 | Greece |
| Rhodes | 85100 | Greece |
| Thessaloniki | 546 42 | Greece |
| Ajka | H-8400 | Hungary |
| Balassagyarmat | 2660 | Hungary |
| Békéscsaba | 5600 | Hungary |
| Budapest | 1067 | Hungary |
| Budapest | 1083 | Hungary |
| Budapest | 1088 | Hungary |
| Budapest | 1097 | Hungary |
| Budapest | H-1125 | Hungary |
| Debrecen | 4032 | Hungary |
| Debrecen | H-4031 | Hungary |
| Győr | 9024 | Hungary |
| Gyula | 5700 | Hungary |
| Kaposvár | 7400 | Hungary |
| Kecskemét | 6000 | Hungary |
| Miskolc | 3529 | Hungary |
| Miskolc | H-3501 | Hungary |
| Mosonmagyaróvár | 9200 | Hungary |
| Nyíregyháza | 4400 | Hungary |
| Pécs | 7623 | Hungary |
| Sopron | 9400 | Hungary |
| Szeged | 6720 | Hungary |
| Székesfehérvár | 8000 | Hungary |
| Szolnok | 5000 | Hungary |
| Szombathely | 9700 | Hungary |
| Tatabánya | 2800 | Hungary |
| Zalaegerszeg | 8900 | Hungary |
| Zalaegerszeg | 8901 | Hungary |
| Pune | Maharashtra | 411001 | India |
| Hyderabad | 500082 | India |
| Kochi | 682017 | India |
| Lucknow | 226010 | India |
| Ludhiana | 141 001 | India |
| Mizoram | 0 | India |
| Mumbai | 400025 | India |
| Mumbai | 400053 | India |
| Noida | 201 301 | India |
| Tehran | 14117 | Iran |
| Tehran | Iran |
| Pescara | Abruzzo | 65100 | Italy |
| Pescara | Abruzzo | 65124 | Italy |
| Brindisi | Apulia | 72100 | Italy |
| Foggia | Apulia | 71100 | Italy |
| Galatina | Apulia | 73013 | Italy |
| San Giovanni Rotondo | Apulia | 71013 | Italy |
| Catanzaro | Calabria | 88100 | Italy |
| Reggio Calabria | Calabria | 89100 | Italy |
| Avellino | Campania | 83100 | Italy |
| Benevento | Campania | 82100 | Italy |
| Gragnano | Campania | 80054 | Italy |
| Naples | Campania | 80123 | Italy |
| Naples | Campania | 80131 | Italy |
| Naples | Campania | 80136 | Italy |
| Naples | Campania | 80138 | Italy |
| Salerno | Campania | 84123 | Italy |
| Bologna | Emilia-Romagna | 40138 | Italy |
| Carpi | Emilia-Romagna | 41012 | Italy |
| Modena | Emilia-Romagna | 41100 | Italy |
| Parma | Emilia-Romagna | 43100 | Italy |
| Ravenna | Emilia-Romagna | 48100 | Italy |
| Udine | Friuli Venezia Giulia | 33100 | Italy |
| Frosinone | Lazio | 03100 | Italy |
| Gaeta | Lazio | 04024 | Italy |
| Rome | Lazio | 00045 | Italy |
| Rome | Lazio | 00149 | Italy |
| Rome | Lazio | 00161 | Italy |
| Rome | Lazio | 00168 | Italy |
| Genoa | Liguria | 16132 | Italy |
| Brescia | Lombardy | 25123 | Italy |
| Brescia | Lombardy | 25125 | Italy |
| Busto Arsizio | Lombardy | 21052 | Italy |
| Como | Lombardy | 22100 | Italy |
| Milan | Lombardy | 20121 | Italy |
| Milan | Lombardy | 20122 | Italy |
| Milan | Lombardy | 20132 | Italy |
| Milan | Lombardy | 20142 | Italy |
| Milan | Lombardy | 20157 | Italy |
| Milan | Lombardy | 20162 | Italy |
| Treviglio | Lombardy | 24047 | Italy |
| Campobasso | Molise | 86100 | Italy |
| Asti | Piedmont | 14100 | Italy |
| Biella | Piedmont | 13900 | Italy |
| Novara | Piedmont | 28100 | Italy |
| Omegna (VB) | Piedmont | 28887 | Italy |
| Orbassano | Piedmont | 10043 | Italy |
| Turin | Piedmont | 10126 | Italy |
| Turin | Piedmont | 10149 | Italy |
| Cagliari | Sardinia | 09042 | Italy |
| Cagliari | Sardinia | 09100 | Italy |
| Sassari | Sardinia | 07100 | Italy |
| Catania | Sicily | 95126 | Italy |
| Comiso | Sicily | 97013 | Italy |
| Messina | Sicily | 98124 | Italy |
| Palermo | Sicily | 90127 | Italy |
| Torrette Di Ancona | The Marches | 60020 | Italy |
| Florence | Tuscany | 50134 | Italy |
| Pisa | Tuscany | 56124 | Italy |
| Perugia | Umbria | 06123 | Italy |
| Padova | Veneto | 35128 | Italy |
| Rovigo | Veneto | 45100 | Italy |
| Hawalli | 32052 | Kuwait |
| Safat | 4077 | Kuwait |
| Safat | 4710 | Kuwait |
| Baabda | 50 | Lebanon |
| Beirut | 11-236 | Lebanon |
| Beirut | 99999 | Lebanon |
| Beirut | Lebanon |
| Saida | Lebanon |
| Tripoli | 371 Tripoli | Lebanon |
| Casablanca | 20000 | Morocco |
| Casablanca | 20100 | Morocco |
| Rabat | 504 | Morocco |
| Rabat | 62000 | Morocco |
| Skopje | 1000 | North Macedonia |
| Faisalabad | Pakistan |
| Hyderābād | 71000 | Pakistan |
| Karachi | Pakistan |
| Lahore | Pakistan |
| Rawalpindi | Pakistan |
| Bialystok | 15-540 | Poland |
| Bydgoszcz | 85-030 | Poland |
| Bytom | 41-902 | Poland |
| Chorzów | 41-500 | Poland |
| Cieszyn | 43-400 | Poland |
| Gdansk | 80-214 | Poland |
| Katowice | 40-752 | Poland |
| Krakow | 30-901 | Poland |
| Krakow | 31-202 | Poland |
| Lodz | 91-347 | Poland |
| Puławy | 24-100 | Poland |
| Racibórz | 47-400 | Poland |
| Tychy | 43-100 | Poland |
| Warsaw | 01-201 | Poland |
| Warsaw | 02-507 | Poland |
| Wałbrzych | 58-300 | Poland |
| Wroclaw | 51-124 | Poland |
| Łańcut | 37-100 | Poland |
| Almada | 2805-267 | Portugal |
| Amadora | 2700-020 | Portugal |
| Aveiro | 3810-096 | Portugal |
| Beja | 7800-309 | Portugal |
| Beja | 7801-849 | Portugal |
| Coimbra | 3041-801 | Portugal |
| Faro | 8000-386 | Portugal |
| Lisbon | 1069-639 | Portugal |
| Lisbon | 1349-019 | Portugal |
| Lisbon | 1649-035 | Portugal |
| Porto | 4202-451 | Portugal |
| Porto | 4369-004 | Portugal |
| Santarém | 2005-177 | Portugal |
| Vila Real | 5000-508 | Portugal |
| Doha | P.O.Box 3051 | Qatar |
| Brasov | 500007 | Romania |
| Brasov | 500174 | Romania |
| Brasov | 500326 | Romania |
| Bucharest | 005098 | Romania |
| Bucharest | 010825 | Romania |
| Bucharest | 020475 | Romania |
| Bucharest | 021105 | Romania |
| Bucharest | 022328 | Romania |
| Bucharest | 030303 | Romania |
| Cluj-Napoca | 400015 | Romania |
| Cluj-Napoca | 400162 | Romania |
| Constanța | 900900 | Romania |
| Craiova | 200515 | Romania |
| Iași | 700111 | Romania |
| Iași | 700116 | Romania |
| Timișoara | 293406 | Romania |
| Belgrade | 11000 | Serbia |
| Kragujevac | 34000 | Serbia |
| Niš | 18000 | Serbia |
| Novi Sad | 21000 | Serbia |
| Banská Bystrica | 975 17 | Slovakia |
| Bratislava | 811 07 | Slovakia |
| Bratislava | 833 03 | Slovakia |
| Bratislava | 833 05 | Slovakia |
| Košice | 040 01 | Slovakia |
| Košice | 04001 | Slovakia |
| Martin | 036 59 | Slovakia |
| Prešov | 080 01 | Slovakia |
| Trenčín | 911 71 | Slovakia |
| Buchun | 420-021 | South Korea |
| Busan | 602-715 | South Korea |
| Seoul | 03080 | South Korea |
| Seoul | 120-752 | South Korea |
| Seoul | 135-710 | South Korea |
| Suwon | 442-723 | South Korea |
| Abu Dhabi | 51900 | United Arab Emirates |
| Dubai | 4545 | United Arab Emirates |
| 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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