Document Detail


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.
MedLine Citation:
PMID:  16093865     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Donald M Jensen; Patrick Marcellin
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Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  European journal of gastroenterology & hepatology     Volume:  17     ISSN:  0954-691X     ISO Abbreviation:  Eur J Gastroenterol Hepatol     Publication Date:  2005 Sep 
Date Detail:
Created Date:  2005-08-11     Completed Date:  2006-02-13     Revised Date:  2013-05-20    
Medline Journal Info:
Nlm Unique ID:  9000874     Medline TA:  Eur J Gastroenterol Hepatol     Country:  England    
Other Details:
Languages:  eng     Pagination:  899-904     Citation Subset:  IM    
Affiliation:
Rush University Medical Center, Chicago, Illinois 60612, USA. Donald_M_Jensen@rush.edu
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MeSH Terms
Descriptor/Qualifier:
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:
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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