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| Sponsor: | Competence Network Viral Hepatitis |
|---|---|
| Collaborator: |
Hannover Clinical Trial Center GmbH |
| Information provided by: | Competence Network Viral Hepatitis |
| ClinicalTrials.gov Identifier: | NCT00803309 |
Purpose
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 |
|---|---|---|
|
Hepatitis C, Chronic |
Drug: pegylated interferon alpha-2b Drug: Ribavirin Drug: pegylated Interferon alpha-2b |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Active Control Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
|
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
|
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
|
|
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
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Markus Cornberg, Dr. med. | +49 511 532 6817 | cornberg.markus@mh-hannover.de |
| Germany | |
| Universitätsklinikum Aachen | Recruiting |
| Aachen, Germany, 52074 | |
| Contact: Wasmuth, Prof. Dr. | |
| Principal Investigator: H. Wasmuth, Prof. Dr. | |
| Ärztehaus Leipziger Straße | Recruiting |
| Berlin, Germany, 10117 | |
| Contact: John, Dr. | |
| Principal Investigator: C. John, 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. | |
| Principal Investigator: J. Gölz, Dr. | |
| Hepatologische Schwerpunktpraxis im bng | Recruiting |
| Berlin, Germany, 10969 | |
| Contact: Möller, Dr. | |
| Principal Investigator: B. Möller, Dr. | |
| Praxis Dr. med. Naumann | Recruiting |
| Berlin, Germany, 10627 | |
| Contact: Naumann, Dr. | |
| Principal Investigator: Naumann, 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. | |
| Kreiskliniken Burghausen/Altötting, Med. Klinik II | Recruiting |
| Burghausen/Altötting, Germany, 84489 | |
| Contact: Kraus, Prof. Dr. | |
| Principal Investigator: M. Kraus, Prof. Dr. | |
| Hepatologische Schwerpunktpraxis im bng | Recruiting |
| Dortmund, Germany, 44263 | |
| Contact: Zehnter, Dr. | |
| Principal Investigator: E. Zehnter, 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. | |
| Universitätsklinikum Essen | Recruiting |
| Essen, Germany, 45122 | |
| Contact: Gerken, Prof. Dr. | |
| Principal Investigator: G. Gerken, Prof. Dr. | |
| Klinikum der J.W. Goethe-Universität | Recruiting |
| Frankfurt, Germany, 60590 | |
| Contact: Zeuzem, Prof. Dr. | |
| Principal Investigator: S. Zeuzem, Prof. Dr. | |
| Vitanus GmbH | Recruiting |
| Frankfurt, Germany, 60596 | |
| Contact: Cordes, Dr. | |
| Principal Investigator: H.-J. Cordes, Dr. | |
| Praxis Zentrum Gastroenterologie und Endokrinologie | Recruiting |
| Freiburg, Germany, 79098 | |
| Contact: Rössle, Prof. Dr. | |
| Principal Investigator: M. Rössle, Prof. Dr. | |
| IPM-Studycenter GmbH & Co. KG | Recruiting |
| Hamburg, Germany, 20099 | |
| Contact: C. Hoffmann, Dr. | |
| Principal Investigator: C. Hoffmann, 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. | |
| Praxis Dr. med. S. Holm | Recruiting |
| Hannover, Germany, 30159 | |
| Contact: Holm, Dr. | |
| Principal Investigator: S. Holm, Dr. | |
| Medizinische Hochschule Hannover, Zentrum Innere Medizin | Recruiting |
| Hannover, Germany, 30625 | |
| Contact: M. P. Manns, Prof. Dr. | |
| Principal Investigator: M. P. Manns, Prof. Dr. | |
| Medizinische Fakultät der Universität Heidelberg, Innere Medizin IV | Recruiting |
| Heidelberg, Germany, 69120 | |
| Contact: Eisenbach, Dr. | |
| Principal Investigator: C. Eisenbach, Dr. | |
| Hepatologische Schwerpunktpraxis im bng | Recruiting |
| Herne, Germany, 44623 | |
| Contact: Hüppe, Dr. | |
| Principal Investigator: D. Hüppe, Dr. | |
| Universitätskliniken des Saarlandes, Innere Medizin II, Gastroenterologie | Recruiting |
| Homburg, Germany, 66424 | |
| Contact: Lammert, Prof. Dr. | |
| Principal Investigator: F. Lammert, Prof. Dr. | |
| Klinik für Innere Medizin der FSU | Recruiting |
| Jena, Germany, 07747 | |
| Contact: Stallmach, Prof. Dr. | |
| Principal Investigator: A. Stallmach, Prof. Dr. | |
| Gastroenterologische Gemeinschaftspraxis | Recruiting |
| Kiel, Germany, 24146 | |
| Contact: Hinrichsen, PD Dr. | |
| Principal Investigator: H. Hinrichsen, PD 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: K. Fellermann, Dr. | |
| Principal Investigator: K. Fellermann, Dr. | |
| Otto-von-Guericke Universität Magdeburg | Recruiting |
| Magdeburg, Germany, 39120 | |
| Contact: Malfertheiner, Prof. Dr. | |
| Principal Investigator: P. Malfertheiner, Prof. Dr. | |
| Klinikum der Johannes Gutenberg Universität Med. Klinik | Recruiting |
| Mainz, Germany, 55131 | |
| Contact: M. Schuchmann, Dr. | |
| Principal Investigator: M. Schuchmann, Dr. | |
| Universitäts-Klinikum Mannheim, Med. Klinik II | Recruiting |
| Mannheim, Germany, 68167 | |
| Contact: Singer, Prof. Dr. | |
| Principal Investigator: M. Singer, Prof. Dr. | |
| Hepatologische Schwerpunktpraxis im bng | Recruiting |
| Minden, Germany, 32423 | |
| Contact: Roggel, Dr. | |
| Principal Investigator: C. Roggel, Dr. | |
| Klinikum Großhadern, Med. Klinik 2 | Recruiting |
| München, Germany, 81366 | |
| Contact: Zachoval, Prof. Dr. | |
| Principal Investigator: R. Zachoval, Prof. Dr. | |
| Universitätsklinikum Münster, Med. Klinik und Poliklinik B | Recruiting |
| Münster, Germany, 48149 | |
| Contact: Lügering, PD Dr. | |
| Principal Investigator: A. Lügering, PD Dr. | |
| Zentrum für Interdisziplinäre Medizin | Recruiting |
| Münster, Germany, 48143 | |
| Contact: Busch, Dr. | |
| Principal Investigator: H. Busch, Dr. | |
| St.-Theresien-Krankenhaus | Recruiting |
| Nürnberg, Germany, 90491 | |
| Contact: Norgauer, Dr. | |
| Principal Investigator: W. Norgauer, Dr. | |
| St. Josef Hospital | Recruiting |
| Oberhausen, Germany, 46045 | |
| Contact: Niederau, Prof. Dr. | |
| Principal Investigator: C. Niederau, Prof. Dr. | |
| Hepatologische Schwerpunktpraxis im bng | Terminated |
| Offenbach, Germany, 63065 | |
| St.-Josefs-Klinik, Med. Klinik | Recruiting |
| Offenburg, Germany, 77654 | |
| Contact: Link, Dr. | |
| Principal Investigator: R. Link, Dr. | |
| Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin I | Recruiting |
| Regensburg, Germany, 93053 | |
| Contact: Wiest, Dr. | |
| Principal Investigator: R. Wiest, Dr. | |
| Diakoniekrankenhaus, Med. Klinik II | Recruiting |
| Rotenburg (Wuemme), Germany, 27356 | |
| Contact: Arnold, Prof. Dr. | |
| Principal Investigator: J. Arnold, Prof. Dr. | |
| Praxis Dr. med. A. Trein | Recruiting |
| Stuttgart, Germany, 70197 | |
| Contact: Trein, Dr. | |
| Principal Investigator: A. Trein, Dr. | |
| Universitätsklinikum Tübingen Medizinische Klinik I | Recruiting |
| Tübingen, Germany, 70206 | |
| Contact: M. Gregor, Prof. Dr. | |
| Principal Investigator: M. Gregor, Prof. 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: H. Klinker, Prof. Dr. | |
| Principal Investigator: H. Klinker, Prof. Dr. | |
| Study Director: | Michael P. Manns, Prof. Dr. | Hannover Medical School |
More Information
| Responsible Party: | Competence Network Viral Hepatitis ( Prof. Dr. med. M. P. Manns ) |
| ClinicalTrials.gov Identifier: | NCT00803309 History of Changes |
| Other Study ID Numbers: | P05498 |
| Study First Received: | December 4, 2008 |
| Last Updated: | October 23, 2009 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Chronic HCV-genotype 2/3 Efficacy of treatment extension PegIntron |
pegylated interferon alpha-2b Rebetol ribavirin |
|
Hepatitis C Hepatitis C, Chronic Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Hepatitis, Chronic Interferon-alpha Interferon Alfa-2a Interferon Type I, Recombinant Interferon Alfa-2b Interferons |
Ribavirin Peginterferon alfa-2b Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antiviral Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |