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The primary objective of this program is to provide Daclatasvir in combination with Sofosbuvir with or without Ribavirin to subjects with chronic Hepatitis C who are at a high risk of liver decompensation or death within 12 months if left untreated and who have no available therapeutic options.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclatasvir | Drug |
| ||
| Sofosbuvir | Drug | |||
| Ribavirin | Drug |
This program is conducted in the EU (Germany, Austria, Norway, The Netherlands, Sweden and United Kingdom only)
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Amstetten | Austria | ||||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27845298 | Derived | Rockstroh JK, Ingiliz P, Petersen J, Peck-Radosavljevic M, Welzel TM, Van der Valk M, Zhao Y, Jimenez-Exposito MJ, Zeuzem S. Daclatasvir plus sofosbuvir, with or without ribavirin, in real-world patients with HIV-HCV coinfection and advanced liver disease. Antivir Ther. 2017;22(3):225-236. doi: 10.3851/IMP3108. Epub 2016 Nov 15. | |
| 27605539 |
| Label | URL |
|---|---|
| EAP Investigator Requests | View source |
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| Braunua/Inn |
| Austria |
| Local Institution | Graz | Austria |
| Local Institution | Innsbruck | Austria |
| Local Institution | Linz | Austria |
| Local Institution | Oberndorf | Austria |
| Local Institution | Oberpullendorf | Austria |
| Local Institution | Salzburg | Austria |
| Local Institution | Vienna | Austria |
| Local Institution | Aachen | Germany |
| Local Institution | Augsburg | Germany |
| Local Institution | Berlin | Germany |
| Local Institution | Bonn | Germany |
| Local Institution | Cologne | Germany |
| Local Institution | Essen | Germany |
| Local Institution | Frankfurt | Germany |
| Local Institution | Frankfurt am Main | Germany |
| Local Institution | Hamburg | Germany |
| Local Institution | Hanover | Germany |
| Local Institution | Heidelberg | Germany |
| Local Institution | Herne | Germany |
| Local Institution | Jena | Germany |
| Local Institution | Kiel | Germany |
| Local Institution | Leipzig | Germany |
| Local Institution | München | Germany |
| Local Institution | Münster | Germany |
| Local Institution | Stuttgart | Germany |
| Local Institution | Tübingen | Germany |
| Local Institution | Ulm | Germany |
| Local Institution | Würzburg | Germany |
| Local Institution | Amsterdam | Netherlands |
| Local Institution | Rotterdam | Netherlands |
| Local Institution | Urecht | Netherlands |
| Local Institution | Falun | Sweden |
| Local Institution | Gothenburg | Sweden |
| Local Institution | Helsingborg | Sweden |
| Local Institution | Kalmar | SE-391 85 | Sweden |
| Local Institution | Luleå | Sweden |
| Local Institution | Lund | Sweden |
| Local Institution | Stockholm | Sweden |
| Local Institution | Sundsvall | Sweden |
| Local Institution | Plymouth | Devon | United Kingdom |
| Local Institution | London | Greater London | United Kingdom |
| Local Institution | Manchester | Greater Manchester | United Kingdom |
| Local Instituition | Liverpool | Merseyside | L7 8XP | United Kingdom |
| Local Institution | Nottingham | Nottinghamshire | United Kingdom |
| Local Institution | Oxford | Oxfordshire | United Kingdom |
| Local Institution | Newcastle upon Tyne | Tyne and Wear | United Kingdom |
| Local Institution | Birmingham | West Midlands | United Kingdom |
| Local Institution | Leeds | Yorkshire | United Kingdom |
| Local Institution | Brighton | United Kingdom |
| Local Institution | Cardiff | United Kingdom |
| Local Institution | Frimley | United Kingdom |
| Local Institution | Guildford | United Kingdom |
| Local Institution | London | United Kingdom |
| Local Institution | Wrexham | United Kingdom |
| Welzel TM, Petersen J, Herzer K, Ferenci P, Gschwantler M, Wedemeyer H, Berg T, Spengler U, Weiland O, van der Valk M, Rockstroh J, Peck-Radosavljevic M, Zhao Y, Jimenez-Exposito MJ, Zeuzem S. Daclatasvir plus sofosbuvir, with or without ribavirin, achieved high sustained virological response rates in patients with HCV infection and advanced liver disease in a real-world cohort. Gut. 2016 Nov;65(11):1861-1870. doi: 10.1136/gutjnl-2016-312444. Epub 2016 Sep 7. |
| 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 |
|---|---|
| C549273 | daclatasvir |
| D000069474 | Sofosbuvir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
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