PittsburghV1, PubMed, Checkpoint, bibRecord, 003361

Design of the INHIBIT trial: preventing inhibitors by avoiding 'danger', prolonging half-life and promoting tolerance.

Identifieur interne : 003361 ( PubMed/Checkpoint ); précédent : 003360; suivant : 003362

Design of the INHIBIT trial: preventing inhibitors by avoiding 'danger', prolonging half-life and promoting tolerance.

Auteurs : Margaret V. Ragni [États-Unis] ; Lynn M. Malec

Source :

Expert review of hematology [ 1747-4094 ] ; 2014.

RBID : pubmed:25374055

Descripteurs français

KwdFr :
- Enfant, Enfant d'âge préscolaire, Facteur VIII (administration et posologie), Facteur VIII (immunologie), Facteur VIII (usage thérapeutique), Fragments Fc des immunoglobulines (administration et posologie), Fragments Fc des immunoglobulines (immunologie), Fragments Fc des immunoglobulines (usage thérapeutique), Humains, Hémophilie A (traitement médicamenteux), Immunité cellulaire (), Lymphocytes T (), Lymphocytes T (immunologie), Protéines de fusion recombinantes (administration et posologie), Protéines de fusion recombinantes (immunologie), Protéines de fusion recombinantes (usage thérapeutique), Période, Tolérance immunitaire ().
MESH :
- administration et posologie : Facteur VIII, Fragments Fc des immunoglobulines, Protéines de fusion recombinantes.
- immunologie : Facteur VIII, Fragments Fc des immunoglobulines, Lymphocytes T, Protéines de fusion recombinantes.
- traitement médicamenteux : Hémophilie A.
- usage thérapeutique : Facteur VIII, Fragments Fc des immunoglobulines, Protéines de fusion recombinantes.
- Enfant, Enfant d'âge préscolaire, Humains, Immunité cellulaire, Lymphocytes T, Période, Tolérance immunitaire.

English descriptors

KwdEn :
- Child, Child, Preschool, Factor VIII (administration & dosage), Factor VIII (immunology), Factor VIII (therapeutic use), Half-Life, Hemophilia A (drug therapy), Humans, Immune Tolerance (drug effects), Immunity, Cellular (drug effects), Immunoglobulin Fc Fragments (administration & dosage), Immunoglobulin Fc Fragments (immunology), Immunoglobulin Fc Fragments (therapeutic use), Recombinant Fusion Proteins (administration & dosage), Recombinant Fusion Proteins (immunology), Recombinant Fusion Proteins (therapeutic use), T-Lymphocytes (drug effects), T-Lymphocytes (immunology).
MESH :
- chemical , administration & dosage : Factor VIII, Immunoglobulin Fc Fragments, Recombinant Fusion Proteins.
- chemical , immunology : Factor VIII, Immunoglobulin Fc Fragments, Recombinant Fusion Proteins.
- chemical , therapeutic use : Factor VIII, Immunoglobulin Fc Fragments, Recombinant Fusion Proteins.
- drug effects : Immune Tolerance, Immunity, Cellular, T-Lymphocytes.
- drug therapy : Hemophilia A.
- immunology : T-Lymphocytes.
- Child, Child, Preschool, Half-Life, Humans.

Abstract

Inhibitor formation is among the most serious complications of hemophilia treatment. With the US FDA licensure of the novel long-lasting recombinant factor VIII (FVIII) Fc fusion protein, Eloctate, which prolongs FVIII half-life, we propose an innovative approach to prevent inhibitor formation. In this paper, we describe a multicenter, Phase II, single-arm, 48-week trial, the INHIBIT trial, to determine if Eloctate, begun before a bleed and continued as once weekly prophylaxis, will reduce inhibitor formation in children with hemophilia A. We hypothesize that avoiding 'danger,' that is, immune activation by a bleed at first factor exposure and prolonging FVIII half-life will prevent inhibitors and promote FVIII-specific T-cell tolerance. If successful, this approach will suggest a new paradigm in clinical practice.

DOI: 10.1586/17474086.2014.963550
PubMed: 25374055

Affiliations:

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Le document en format XML

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<term>Immunoglobulin Fc Fragments</term>
<term>Recombinant Fusion Proteins</term>
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<term>Immunoglobulin Fc Fragments</term>
<term>Recombinant Fusion Proteins</term>
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<term>Protéines de fusion recombinantes</term>
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<term>Protéines de fusion recombinantes</term>
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<term>Humans</term>
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<front><div type="abstract" xml:lang="en">Inhibitor formation is among the most serious complications of hemophilia treatment. With the US FDA licensure of the novel long-lasting recombinant factor VIII (FVIII) Fc fusion protein, Eloctate, which prolongs FVIII half-life, we propose an innovative approach to prevent inhibitor formation. In this paper, we describe a multicenter, Phase II, single-arm, 48-week trial, the INHIBIT trial, to determine if Eloctate, begun before a bleed and continued as once weekly prophylaxis, will reduce inhibitor formation in children with hemophilia A. We hypothesize that avoiding 'danger,' that is, immune activation by a bleed at first factor exposure and prolonging FVIII half-life will prevent inhibitors and promote FVIII-specific T-cell tolerance. If successful, this approach will suggest a new paradigm in clinical practice.</div>
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<CommentsCorrections RefType="Cites"><RefSource>J Leukoc Biol. 2008 Mar;83(3):546-52</RefSource>
<PMID Version="1">18032691</PMID>
</CommentsCorrections>
<CommentsCorrections RefType="Cites"><RefSource>Haemophilia. 2008 Jul;14 Suppl 3:36-42</RefSource>
<PMID Version="1">18510520</PMID>
</CommentsCorrections>
<CommentsCorrections RefType="Cites"><RefSource>Haemophilia. 2008 Jul;14 Suppl 3:188-95</RefSource>
<PMID Version="1">18510541</PMID>
</CommentsCorrections>
<CommentsCorrections RefType="Cites"><RefSource>Blood. 2008 Oct 15;112(8):3303-11</RefSource>
<PMID Version="1">18660382</PMID>
</CommentsCorrections>
<CommentsCorrections RefType="Cites"><RefSource>Haemophilia. 2009 Jan;15(1):135-41</RefSource>
<PMID Version="1">18700842</PMID>
</CommentsCorrections>
<CommentsCorrections RefType="Cites"><RefSource>Exp Hematol. 2009 Jun;37(6):744-54</RefSource>
<PMID Version="1">19463774</PMID>
</CommentsCorrections>
<CommentsCorrections RefType="Cites"><RefSource>Blood. 2009 Jul 16;114(3):677-85</RefSource>
<PMID Version="1">19458355</PMID>
</CommentsCorrections>
<CommentsCorrections RefType="Cites"><RefSource>Haemophilia. 2009 Sep;15(5):1074-82</RefSource>
<PMID Version="1">19563499</PMID>
</CommentsCorrections>
</CommentsCorrectionsList>
<MeshHeadingList><MeshHeading><DescriptorName UI="D002648" MajorTopicYN="N">Child</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D002675" MajorTopicYN="N">Child, Preschool</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005169" MajorTopicYN="N">Factor VIII</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
<QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName>
<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006207" MajorTopicYN="N">Half-Life</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006467" MajorTopicYN="N">Hemophilia A</DescriptorName>
<QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D007108" MajorTopicYN="N">Immune Tolerance</DescriptorName>
<QualifierName UI="Q000187" MajorTopicYN="N">drug effects</QualifierName>
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<MeshHeading><DescriptorName UI="D007111" MajorTopicYN="N">Immunity, Cellular</DescriptorName>
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<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
<QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName>
<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D011993" MajorTopicYN="N">Recombinant Fusion Proteins</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
<QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName>
<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D013601" MajorTopicYN="N">T-Lymphocytes</DescriptorName>
<QualifierName UI="Q000187" MajorTopicYN="N">drug effects</QualifierName>
<QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName>
</MeshHeading>
</MeshHeadingList>
<OtherID Source="NLM">NIHMS667880</OtherID>
<OtherID Source="NLM">PMC4356531</OtherID>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Tregs</Keyword>
<Keyword MajorTopicYN="N">coagulation factor VIII</Keyword>
<Keyword MajorTopicYN="N">hemophilia A</Keyword>
<Keyword MajorTopicYN="N">inhibitor formation</Keyword>
<Keyword MajorTopicYN="N">long-lasting factor VIII</Keyword>
<Keyword MajorTopicYN="N">tolerance</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2014</Year>
<Month>11</Month>
<Day>7</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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<PubMedPubDate PubStatus="pubmed"><Year>2014</Year>
<Month>11</Month>
<Day>7</Day>
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<PubMedPubDate PubStatus="medline"><Year>2015</Year>
<Month>7</Month>
<Day>4</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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<PublicationStatus>ppublish</PublicationStatus>
<ArticleIdList><ArticleId IdType="pubmed">25374055</ArticleId>
<ArticleId IdType="doi">10.1586/17474086.2014.963550</ArticleId>
<ArticleId IdType="pmc">PMC4356531</ArticleId>
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<affiliations><list><country><li>États-Unis</li>
</country>
<region><li>Pennsylvanie</li>
</region>
<settlement><li>Pittsburgh</li>
</settlement>
<orgName><li>Université de Pittsburgh</li>
</orgName>
</list>
<tree><noCountry><name sortKey="Malec, Lynn M" sort="Malec, Lynn M" uniqKey="Malec L" first="Lynn M" last="Malec">Lynn M. Malec</name>
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<country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Ragni, Margaret V" sort="Ragni, Margaret V" uniqKey="Ragni M" first="Margaret V" last="Ragni">Margaret V. Ragni</name>
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Design of the INHIBIT trial: preventing inhibitors by avoiding 'danger', prolonging half-life and promoting tolerance.

Design of the INHIBIT trial: preventing inhibitors by avoiding 'danger', prolonging half-life and promoting tolerance.

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