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Sponsors and Collaborators: |
Competence Network Viral Hepatitis Hannover Clinical Trial Center GmbH |
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Information provided by: | Competence Network Viral Hepatitis |
ClinicalTrials.gov Identifier: | NCT00803309 |
In this study we intend to treat patients with chronic hepatitis C of genotype 2 or 3 having characteristics associated with poor treatment response for additional 12 or 24 weeks beyond the standard treatment of PEG-IFN alpha-2b plus ribavirin.
The objective of this study is to compare the efficacy of a treatment extension of 12 versus 24 weeks in patients with HCV-genotypes 2 and 3 who are treated with 1.5 µg/kg PEG-IFN alpha-2b and 800-1400 mg ribavirin (standard dose) for 24 weeks (standard duration) and who are not HCV-RNA negative (< 15 IU/ml) after 4 weeks of standard treatment but HCV-RNA negative after 16-24 weeks of standard treatment.
Condition | Intervention | Phase |
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Hepatitis C, Chronic |
Drug: pegylated interferon alpha-2b Drug: Ribavirin Drug: pegylated Interferon alpha-2b |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Optimization of Treatment for Patients With Chronic Hepatitis C Infected With HCV-Genotype 2 or 3: 12 vs. 24 Weeks of Treatment Extension for Patients Without Rapid Virological Response |
Estimated Enrollment: | 150 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
PegIntron® 1.5 µg/kg once weekly (QW) subcutaneous (sc) plus Rebetol® 800-1400 mg per os divided in 2 daily doses for additional 24 weeks beyond standard treatment with 24 weeks follow-up
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Drug: pegylated interferon alpha-2b
1.5 µg/kg once weekly, syringe, 24 weeks
Drug: Ribavirin
800-1400 mg per os, daily, tablets, 24 weeks
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B: Active Comparator
PegIntron® 1.5 µg/kg QW sc plus Rebetol® 800-1400 mg per os divided in 2 daily doses for additional 12 weeks beyond standard treatment with 24 weeks follow-up
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Drug: pegylated Interferon alpha-2b
1.5 µg/kg once weekly, syringe, 12 weeks
Drug: Ribavirin
800-1400 mg per os, daily, tablets, 12 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Markus Cornberg, Dr. med. | +49 511 532 6817 | cornberg.markus@mh-hannover.de |
Germany | |
Medizinische Hochschule Hannover, Zentrum Innere Medizin | Recruiting |
Hannover, Germany, 30625 | |
Contact: M. P. Manns, Prof. Dr. | |
Principal Investigator: M. P. Manns, Prof. Dr. | |
Universitätsklinikum Aachen | Recruiting |
Aachen, Germany, 52074 | |
Contact: Wasmuth, PD Dr. | |
Principal Investigator: H. Wasmuth, PD Dr. | |
Gastroenterologische Gemeinschaftspraxis | Recruiting |
Kiel, Germany, 24146 | |
Contact: Hinrichsen, PD Dr. | |
Principal Investigator: H. Hinrichsen, PD Dr. | |
Charité Campus Virchow-Klinikum, Med. Klinik für Gastroenterologie und Hepatologie | Recruiting |
Berlin, Germany, 13353 | |
Contact: Berg, Prof. Dr. | |
Principal Investigator: T. Berg, Prof. Dr. | |
Praxis Dr. med. J. Gölz | Recruiting |
Berlin, Germany, 14057 | |
Contact: Gölz, Dr. | |
Ärztehaus Leipziger Straße | Recruiting |
Berlin, Germany, 10117 | |
Contact: John, Dr. | |
Principal Investigator: C. John, Dr. | |
Praxis Dr. med. U. Meyer | Recruiting |
Berlin, Germany, 10627 | |
Contact: Meyer, Dr. | |
Principal Investigator: U. Meyer, Dr. | |
Hepatologische Schwerpunktpraxis im bng | Recruiting |
Berlin, Germany, 10969 | |
Contact: Möller, Dr. | |
Principal Investigator: B. Möller, Dr. | |
Friedrich-Wilhelms-Universität, Med. Klinik und Poliklinik I | Recruiting |
Bonn, Germany, 53105 | |
Contact: Spengler, Prof. Dr. | |
Principal Investigator: U. Spengler, Prof. Dr. | |
Klinikum Bremen-Mitte gGmbH | Recruiting |
Bremen, Germany, 28205 | |
Contact: Ockenga, PD Dr. | |
Principal Investigator: J. Ockenga, PD Dr. | |
Krankenhaus Dresden-Friedrichstadt | Recruiting |
Dresden, Germany, 01067 | |
Contact: Wollschläger, Dr. | |
Principal Investigator: S. Wollschläger, Dr. | |
Fachärztliche Gemeinschaftspraxis | Recruiting |
Düsseldorf, Germany, 40223 | |
Contact: Carls, Dr. | |
Principal Investigator: H. Carls, Dr. | |
St. Josef Hospital | Recruiting |
Oberhausen, Germany, 46045 | |
Contact: Niederau, Prof. Dr. | |
Principal Investigator: C. Niederau, Prof. Dr. | |
St.-Theresien-Krankenhaus | Recruiting |
Nürnberg, Germany, 90491 | |
Contact: Norgauer, Dr. | |
Principal Investigator: W. Norgauer, Dr. | |
Universitätsklinikum Essen | Recruiting |
Essen, Germany, 45122 | |
Contact: Gerken, Prof. Dr. | |
Principal Investigator: G. Gerken, Prof. Dr. | |
Hepatologische Schwerpunktpraxis im bng | Recruiting |
Offenbach, Germany, 63065 | |
Contact: Leuschner, Dr. | |
Principal Investigator: M. Leuschner, Dr. | |
Vitanus GmbH | Recruiting |
Frankfurt, Germany, 60596 | |
Contact: Cordes, Dr. | |
Principal Investigator: H.-J. Cordes, Dr. | |
Klinikum der J.W. Goethe-Universität | Recruiting |
Frankfurt, Germany, 60590 | |
Contact: Zeuzem, Prof. Dr. | |
Principal Investigator: S. Zeuzem, Prof. Dr. | |
Praxis Zentrum Gastroenterologie und Endokrinologie | Recruiting |
Freiburg, Germany, 79098 | |
Contact: Rössle, Prof. Dr. | |
Principal Investigator: M. Rössle, Prof. Dr. | |
Asklepios Klinik St. Georg, Institut für interdiziplinäre Infektiologie | Recruiting |
Hamburg, Germany, 20099 | |
Contact: Stoehr, Dr. | |
Principal Investigator: A. Stoehr, Dr. | |
Universitätsklinikum Hamburg-Eppendorf, Klinik für Innere Medizin | Recruiting |
Hamburg, Germany, 20246 | |
Contact: Lohse, Prof. Dr. | |
Principal Investigator: A. Lohse, Prof. Dr. | |
IPM-Studycenter GmbH & Co. KG | Recruiting |
Hamburg, Germany, 20099 | |
Contact: Weitner, Dr. | |
Principal Investigator: L. Weitner, Dr. | |
Kreiskliniken Burghausen/Altötting, Med. Klinik II | Recruiting |
Burghausen/Altötting, Germany, 84489 | |
Contact: Kraus, Prof. Dr. | |
Principal Investigator: M. Kraus, Prof. Dr. | |
Praxis Dr. med. S. Holm | Recruiting |
Hannover, Germany, 30159 | |
Contact: Holm, Dr. | |
Principal Investigator: S. Holm, Dr. | |
Medizinische Fakultät der Universität Heidelberg, Innere Medizin IV | Recruiting |
Heidelberg, Germany, 69120 | |
Contact: Eisenbach, Dr. | |
Principal Investigator: C. Eisenbach, Dr. | |
Klinik für Innere Medizin der FSU | Recruiting |
Jena, Germany, 07747 | |
Contact: Stallmach, Prof. Dr. | |
Principal Investigator: A. Stallmach, Prof. Dr. | |
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Allgemeine Innere Medizin | Recruiting |
Kiel, Germany, 24105 | |
Contact: Günther, Dr. | |
Principal Investigator: R. Günther, Dr. | |
Universitätsklinikum Leipzig | Recruiting |
Leipzig, Germany, 04103 | |
Contact: Wiegand, Dr. | |
Principal Investigator: J. Wiegand, Dr. | |
Universitätklinikum Schleswig-Holstein, Campus Lübeck, Med. Klinik I | Recruiting |
Lübeck, Germany, 23538 | |
Contact: Schmidt, Dr. | |
Principal Investigator: K. Schmidt, Dr. | |
Otto-von-Guericke Universität Magdeburg | Recruiting |
Magdeburg, Germany, 39120 | |
Contact: Malfertheiner, Prof. Dr. | |
Principal Investigator: P. Malfertheiner, Prof. Dr. | |
Universitäts-Klinikum Mannheim, Med. Klinik II | Recruiting |
Mannheim, Germany, 68167 | |
Contact: Singer, Prof. Dr. | |
Principal Investigator: M. Singer, Prof. Dr. | |
Klinikum Großhadern, Med. Klinik 2 | Recruiting |
München, Germany, 81366 | |
Contact: Zachoval, Prof. Dr. | |
Principal Investigator: R. Zachoval, Prof. Dr. | |
Zentrum für Interdisziplinäre Medizin | Recruiting |
Münster, Germany, 48143 | |
Contact: Busch, Dr. | |
Principal Investigator: H. Busch, Dr. | |
Hepatologische Schwerpunktpraxis im bng | Recruiting |
Herne, Germany, 44623 | |
Contact: Hüppe, Dr. | |
Principal Investigator: D. Hüppe, Dr. | |
Universitätsklinikum Münster, Med. Klinik und Poliklinik B | Recruiting |
Münster, Germany, 48149 | |
Contact: Lügering, PD Dr. | |
Principal Investigator: A. Lügering, PD Dr. | |
Hepatologische Schwerpunktpraxis im bng | Recruiting |
Minden, Germany, 32423 | |
Contact: Roggel, Dr. | |
Principal Investigator: C. Roggel, Dr. | |
Hepatologische Schwerpunktpraxis im bng | Recruiting |
Dortmund, Germany, 44263 | |
Contact: Zehnter, Dr. | |
Principal Investigator: E. Zehnter, Dr. | |
Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin I | Recruiting |
Regensburg, Germany, 93053 | |
Contact: Wiest, Dr. | |
Principal Investigator: R. Wiest, Dr. | |
Universitätskliniken des Saarlandes, Innere Medizin II, Gastroenterologie | Recruiting |
Homburg, Germany, 66424 | |
Contact: Lammert, Prof. Dr. | |
Principal Investigator: F. Lammert, Prof. Dr. | |
St.-Josefs-Klinik, Med. Klinik | Recruiting |
Offenburg, Germany, 77654 | |
Contact: Link, Dr. | |
Principal Investigator: R. Link, Dr. | |
Praxis Dr. med. A. Trein | Recruiting |
Stuttgart, Germany, 70197 | |
Contact: Trein, Dr. | |
Principal Investigator: A. Trein, Dr. | |
Universitätsklinikum Ulm, Abteilung für Innere Medizin I | Recruiting |
Ulm, Germany, 89081 | |
Contact: Dikopoulos, Dr. | |
Principal Investigator: N. Dikopoulos, Dr. | |
Med. Poliklinik der Universität Würzburg | Recruiting |
Würzburg, Germany, 97080 | |
Contact: Kliniker, Prof. Dr. | |
Principal Investigator: H. Kliniker, Prof. Dr. | |
Diakoniekrankenhaus, Med. Klinik II | Recruiting |
Rotenburg (Wuemme), Germany, 27356 | |
Contact: Arnold, Prof. Dr. | |
Principal Investigator: J. Arnold, Prof. Dr. |
Study Director: | Michael P. Manns, Prof. Dr. | Hannover Medical School |
Responsible Party: | Hep-Net ( Prof. Dr. med. M. P. Manns ) |
Study ID Numbers: | P05498 |
Study First Received: | December 4, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00803309 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Chronic HCV-genotype 2/3 Efficacy of treatment extension PegIntron Rebetol |
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 Molecular Mechanisms of Pharmacological Action Flaviviridae Infections Immunologic Factors Antineoplastic Agents Growth Substances |
Physiological Effects of Drugs Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |