| Rationale and design of the REPEAT study: a phase III, randomized, clinical trial of peginterferon alfa-2a (40 kDa) plus ribavirin in non-responders to peginterferon alfa-2b (12 kDa) plus ribavirin. | |
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MedLine Citation:
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PMID: 16093865 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: The REtreatment with PEgasys in pATients not responding to prior peginterferon alfa-2b (12 kDa)/ribavirin combination therapy (REPEAT) study is a phase III, randomized, parallel group, multinational clinical trial. The main objective is to compare the efficacy and safety of 48 and 72 weeks of treatment with peginterferon alfa-2a (40 kDa) (PEGASYS) plus ribavirin (COPEGUS) in patients who did not respond to previous peginterferon alfa-2b (12 kDa) plus ribavirin therapy. STUDY DESIGN: Patients will be randomized to one of four treatment groups: two groups will receive peginterferon alfa-2a (40 kDa) at the standard dose of 180 mug once weekly for 48 or 72 weeks. The other two groups will receive a 12-week high-dose induction regimen with peginterferon alfa-2a (40 kDa) 360 mug once-weekly followed by 60 or 36 weeks of peginterferon alfa-2a (40 kDa) 180 mug once weekly. All patients will receive the standard dose of ribavirin (1000 or 1200 mg/day) throughout treatment. The primary efficacy variable is the rate of sustained virological response, defined as non-detectable hepatitis C virus (HCV) RNA (<50 IU/ml) 24 weeks after the end of treatment. Secondary variables include the percentage of patients with non-detectable HCV RNA at the end of treatment, the percentage of patients with at least a 2-log10 decrease in serum HCV RNA at weeks 12 and 24 of treatment, and the percentage of patients with non-detectable HCV RNA at treatment weeks 12, 24 and 48. Safety data will be recorded and analysed throughout the entire course of the study with the assistance of a Safety Review Board. |
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Authors:
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Donald M Jensen; Patrick Marcellin |
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Publication Detail:
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Type: Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: European journal of gastroenterology & hepatology Volume: 17 ISSN: 0954-691X ISO Abbreviation: Eur J Gastroenterol Hepatol Publication Date: 2005 Sep |
Date Detail:
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Created Date: 2005-08-11 Completed Date: 2006-02-13 Revised Date: 2013-05-20 |
Medline Journal Info:
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Nlm Unique ID: 9000874 Medline TA: Eur J Gastroenterol Hepatol Country: England |
Other Details:
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Languages: eng Pagination: 899-904 Citation Subset: IM |
Affiliation:
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Rush University Medical Center, Chicago, Illinois 60612, USA. Donald_M_Jensen@rush.edu |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Antiviral Agents / adverse effects, therapeutic use* Drug Therapy, Combination Female Hepacivirus / isolation & purification Hepatitis C, Chronic / drug therapy*, virology Humans Interferon-alpha / adverse effects, therapeutic use* Male Middle Aged Polyethylene Glycols / adverse effects, therapeutic use* RNA, Viral / blood Recombinant Proteins Research Design Ribavirin / adverse effects, therapeutic use* Sample Size Treatment Failure Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Antiviral Agents; 0/Interferon-alpha; 0/Polyethylene Glycols; 0/RNA, Viral; 0/Recombinant Proteins; 0/peginterferon alfa-2a; 0/peginterferon alfa-2b; 36791-04-5/Ribavirin; 76543-88-9/interferon alfa-2a; 99210-65-8/interferon alfa-2b |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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