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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-000358-38 | EudraCT Number |
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| Name | Class |
|---|---|
| University Hospital, Saarland | OTHER |
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Patients with chronic hepatitis C genotype 1 virus infection are usually treated with Interferon alfa plus Ribavirin over 48 weeks. For some patients this might be too long, for others too short. An individually adapted therapy length from 24 to 72 weeks will be determined in dependence of the initial virus load and the time to HCV RNA negativity.
The primary objective is to compare the cumulative rate of the sustained viral response (SVR) of the patients with the individually adapted therapy duration to the SVR rates of a historic patient collective under the 48 week standard therapy.
Further objectives of this trial are:
To record the tolerance of the therapy with Peginterferon alfa-2b plus Ribavirin over 72 weeks inclusive the adverse reactions and the withdrawal rates.
To evaluate the biochemical response to the treatment (ALT values during and after the therapy) in comparison to the virological response to the treatment.
To evaluate the validity of the withdrawal rules of this trial at week 12 and 24 in comparison to the 2-log-rule and a qualitative detection of the HCV RNA at week 24 with a detection limit of 50 IU/ml.
To evaluate the impact of the HCV RNA concentration before the therapy, and the HCV kinetic during the therapy on the response to the treatment in the different groups.
To evaluate the impact of the serum concentration of Ribavirin on anaemia and the virological therapy response, as well as the dependence of the serum concentration of Ribavirin on the creatinine clearance in comparison to the body weight.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized therapy | Experimental | Lengh of therapy depends on time point when no HCV RNA is detectable in blood with Versant HCV Qualitative assay. |
|
| Historical control | Other | 48 week standard therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ribavirin | Drug | Rebetol 200 mg: applied as hard capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained viral response (HCV RNA negativity 24 weeks after end of treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Sarrazin, MD, PhD | University Hospital, Saarland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universitätsklinik Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany | ||
| Universitätsklinik Heidelberg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21784046 | Derived | Sarrazin C, Schwendy S, Moller B, Dikopoulos N, Buggisch P, Encke J, Teuber G, Goeser T, Thimme R, Klinker H, Boecher WO, Schulte-Frohlinde E, Prinzing R, Herrmann E, Zeuzem S, Berg T. Improved responses to pegylated interferon alfa-2b and ribavirin by individualizing treatment for 24-72 weeks. Gastroenterology. 2011 Nov;141(5):1656-64. doi: 10.1053/j.gastro.2011.07.019. Epub 2011 Jul 22. |
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| Peginterferon alfa 2b | Drug | PegIntron (50/80/100/120/150 microgram): applied by injection |
|
| Heidelberg |
| Baden-Wurttemberg |
| 69120 |
| Germany |
| Universitätsklinikum Ulm | Ulm | Baden-Wurttemberg | 89081 | Germany |
| Uniklinikum Erlangen | Erlangen | Bavaria | 91056 | Germany |
| Klinikum Großhadern | München | Bavaria | 81377 | Germany |
| Technische Universität München | München | Bavaria | 81675 | Germany |
| Klinikum der Universität Würzburg | Würzburg | Bavaria | 97080 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
| Klinikum der J.W.-Goethe-Universität | Frankfurt am Main | Hesse | 60590 | Germany |
| Praxis für Innere Medizin | Frankfurt am Main | Hesse | 60596 | Germany |
| Medizinische Hochschule Hannover | Hanover | Lower Saxony | 30625 | Germany |
| Universitätsklinikum Aachen | Aachen | Nordrhein.Westfalen | 52074 | Germany |
| St. Josef-Hospital | Bochum | North Rhine-Westphalia | 44791 | Germany |
| Universität zu Köln | Cologne | North Rhine-Westphalia | 50924 | Germany |
| Gemeinschaftspraxis | Düsseldorf | North Rhine-Westphalia | 40237 | Germany |
| Medizinische Universitäts-Klinik Essen | Essen | North Rhine-Westphalia | 45122 | Germany |
| Universitätsklinikum der J. Gutenberg Universität | Mainz | Rhineland-Palatinate | 55131 | Germany |
| Universitätsklinikum des Saarlandes | Homburg / Saar | Saarland | 66421 | Germany |
| Universitätsklinikum Leipzig | Leipzig | Saxony | 04103 | Germany |
| Christian-Albrechts-Universität zu Kiel | Kiel | Schleswig-Holstein | 24105 | Germany |
| Hepatologische Schwerpunktpraxis | Berlin | State of Berlin | 10969 | Germany |
| Charité, Campus Virchow-Klinikum | Berlin | State of Berlin | 13353 | Germany |
| 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 |
|---|---|
| D012254 | Ribavirin |
| C417083 | peginterferon alfa-2b |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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