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Sponsors and Collaborators: |
FGK Clinical Research GmbH Universitätsklinikum des Saarlandes |
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Information provided by: | FGK Clinical Research GmbH |
ClinicalTrials.gov Identifier: | NCT00351403 |
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.
Condition | Intervention | Phase |
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Hepatitis C, Chronic |
Drug: Ribavirin Drug: Peginterferon alfa 2b |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Individually Adapted Therapy Duration From 24 to 72 Weeks for the Treatment of a Chronic Hepatitis C Genotype 1 Infection With Peginterferon Alfa-2b Plus Ribavirin in Dependence of the Initial Concentration and the Decline of the HCV RNA |
Estimated Enrollment: | 390 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christoph Sarrazin, MD. PhD | +49-6841-16-23203 | christoph.sarrazin@uniklinikum-saarland.de |
Contact: Robert Sieglstetter, PhD | +49-89-893119-37 | robert.sieglstetter@fgk-cro.de |
Germany | |
Charité, Campus Virchow-Klinikum | Recruiting |
Berlin, Germany, 13353 | |
Hepatologische Schwerpunktpraxis | Recruiting |
Berlin, Germany, 10969 | |
Universitätsklinikum Hamburg-Eppendorf | Recruiting |
Hamburg, Germany, 20246 | |
Germany, Baden-Württemberg | |
Medizinische Universitätsklinik Freiburg | Recruiting |
Freiburg, Baden-Württemberg, Germany, 79106 | |
Universitätsklinik Heidelberg | Recruiting |
Heidelberg, Baden-Württemberg, Germany, 69120 | |
Universitätsklinikum Ulm | Recruiting |
Ulm, Baden-Württemberg, Germany, 89081 | |
Germany, Bayern | |
Technische Universität München | Recruiting |
München, Bayern, Germany, 81675 | |
Klinikum der Universität Würzburg | Recruiting |
Würzburg, Bayern, Germany, 97080 | |
Uniklinikum Erlangen | Recruiting |
Erlangen, Bayern, Germany, 91056 | |
Klinikum Großhadern | Recruiting |
München, Bayern, Germany, 81377 | |
Germany, Hessen | |
Klinikum der J.W.-Goethe-Universität | Recruiting |
Frankfurt, Hessen, Germany, 60590 | |
Praxis für Innere Medizin | Recruiting |
Frankfurt, Hessen, Germany, 60596 | |
Germany, Niedersachsen | |
Medizinische Hochschule Hannover | Recruiting |
Hannover, Niedersachsen, Germany, 30625 | |
Germany, Nordrhein-Westfalen | |
Medizinische Universitäts-Klinik Essen | Recruiting |
Essen, Nordrhein-Westfalen, Germany, 45122 | |
Gemeinschaftspraxis | Recruiting |
Dusseldorf, Nordrhein-Westfalen, Germany, 40237 | |
St. Josef-Hospital | Recruiting |
Bochum, Nordrhein-Westfalen, Germany, 44791 | |
Universität zu Köln | Recruiting |
Köln, Nordrhein-Westfalen, Germany, 50924 | |
Germany, Nordrhein.Westfalen | |
Universitätsklinikum Aachen | Recruiting |
Aachen, Nordrhein.Westfalen, Germany, 52074 | |
Germany, Rheinland-Pfalz | |
Universitätsklinikum der J. Gutenberg Universität | Recruiting |
Mainz, Rheinland-Pfalz, Germany, 55131 | |
Germany, Saarland | |
Universitätsklinikum des Saarlandes | Recruiting |
Homburg / Saar, Saarland, Germany, 66421 | |
Germany, Sachsen | |
Universitätsklinikum Leipzig | Recruiting |
Leipzig, Sachsen, Germany, 04103 | |
Germany, Schleswig-Holstein | |
Christian-Albrechts-Universität zu Kiel | Recruiting |
Kiel, Schleswig-Holstein, Germany, 24105 |
Study Chair: | Christoph Sarrazin, MD, PhD | Universitätsklinikum des Saarlandes |
Study ID Numbers: | INDIV-2 |
Study First Received: | July 11, 2006 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00351403 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Chronic HCV infection Genotype 1 Individually adapted therapy |
Peginterferon alfa-2b Ribavirin Sustained viral response (SVR) |
Interferon-alpha Liver Diseases Hepatitis, Chronic Interferons Ribavirin Hepatitis, Viral, Human Hepatitis |
Virus Diseases Digestive System Diseases Peginterferon alfa-2b Hepatitis C Interferon Alfa-2a Hepatitis C, Chronic Interferon Alfa-2b |
Antimetabolites Anti-Infective Agents RNA Virus Infections Flaviviridae Infections Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Infection Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |