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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT-Nr.: 2005-001207-19 |
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| Name | Class |
|---|---|
| Universitätsklinikum Hamburg-Eppendorf | OTHER |
| Hoffmann-La Roche | INDUSTRY |
The aim of this study is, to compare the relapse rate in chronic HCV patients with genotype 1 or 3 under the combination of standard dose Peg-Interferon alfa-2a (PEG-IFN alfa-2a), Ribavirin (RBV) and Amantadine (AMA) given for 72 weeks (group A), versus the same combination, given for 48 weeks (group B) in patients who relapsed to previous combination therapy to conventional or pegylated (PEG) Interferon alfa and Ribavirin. Relapse ist defined as percentage of patients with non-detectable HCV-RNA at end of therapy (week 48 GT1/ week 24 GT 3) who become HCV-RNA positive during a follow-up period of 24 weeks.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2a, Ribavirin, Amantadine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| - Comparison of the rate of relapse under the combination of standard dose PegIFN alfa-2a, Ribavirin and Amantadine given for 72 vs. 48 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| relationship between EVR during the first twelve weeks and SVR | ||
| virological response to the combination of standard dose defined as reduction of HCV RNA at week 4, 12, 24, 48 and 72 of treatment, separated between HCV-Genotypes. |
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Inclusion Criteria:
Exclusion Criteria (at screening):
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| Name | Affiliation | Role |
|---|---|---|
| Peter Buggisch, Dr. | Universitätsklinikum Hamburg-Eppendorf, Medizinische Klinik 1 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany | ||
| Universitätsklinikum Ulm |
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| Ulm |
| Baden-Wurttemberg |
| 89081 |
| Germany |
| Universitätsklinikum Mannheim | Mannheim | Baden-Würtemberg | 68167 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | Baden-Württembeg | 69120 | Germany |
| Universitätsklinikum Erlangen | Erlangen | Bavaria | 91054 | Germany |
| Klinikum rechts der Isar der TU München | München | Bavaria | 81675 | Germany |
| Krankenhaus Barmherzige Brüder | Regensburg | Bavaria | 93049 | Germany |
| Klinikum der Universität Regensburg | Regensburg | Bavaria | 93053 | Germany |
| Klinikum der Universität Würzburg | Würzburg | Bavaria | 97080 | Germany |
| Klinikum Bremen-Mitte | Bremen | Free Hanseatic City of Bremen | 28205 | Germany |
| J. W.-Goethe-Universität | Frankfurt am Main | Hesse | 60590 | Germany |
| Medizinische Hochschule Hannover | Hanover | Lower Saxony | 30625 | Germany |
| Universität Rostock | Rostock | Mecklenburg-Vorpommern | 23538 | Germany |
| Klinikum der Ruhr-Universität Bochum | Bochum | North Rhine-Westphalia | 44791 | Germany |
| Universitätsklinikum Bonn | Bonn | North Rhine-Westphalia | 53127 | Germany |
| Klinikum der Universität Köln | Cologne | North Rhine-Westphalia | 50931 | Germany |
| Universitätsklinkum Münster | Münster | North Rhine-Westphalia | 48149 | Germany |
| St-Josef-Hospital | Oberhausen | North Rhine-Westphalia | 46045 | Germany |
| Johannes Gutenberg-Universität Mainz | Mainz | Rhineland-Palatinate | 55131 | Germany |
| Universitätsklinikum des Saarlandes | Bad Homburg/ Saar | Saarland | 66421 | Germany |
| Klinikum der Medizinischen Fakultät der Martin-Luther Universität Halle-Wittenberg | Halle | Saxony-Anhalt | 06120 | Germany |
| Universitätsklinikum Schleswig-Holstein | Kiel | Schleswig-Holstein | 24105 | Germany |
| Universitätsklinikum Schleswig-Holstein, Campus Lübeck | Lübeck | Schleswig-Holstein | 23538 | Germany |
| Praxis Möller/ Heyne | Berlin | State of Berlin | 10696 | Germany |
| Charité, Campus Benjamin Franklin | Berlin | State of Berlin | 12203 | Germany |
| Charité, Campus Virchow-Klinikum, Med. Klinik (Gastroenterologie/ Hepatologie) | Berlin | 13353 | Germany |
| Universitätsklinikum Hamburg-Eppendorf, Med. Klinik 1 | Hamburg | 20246 | Germany |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D012008 | Recurrence |
| 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 |
| D000547 | Amantadine |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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