Long-Acting Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Children
Identifieur interne : 001B85 ( Main/Exploration ); précédent : 001B84; suivant : 001B86Long-Acting Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Children
Auteurs : Gili Kenet [Israël] ; Hervé Chambost [France] ; Christoph Male [Autriche] ; Thierry Lambert [France] ; Susan Halimeh [Allemagne] ; Tatiana Chernova [Russie] ; Maria Elisa Mancuso [Italie] ; Julie Curtin [Australie] ; Christine Voigt [États-Unis] ; Yanyan Li [États-Unis] ; Iris Jacobs [États-Unis] ; Elena Santagostino [Italie]Source :
- Thrombosis and Haemostasis [ 0340-6245 ] ; 2016.
Abstract
A global phase 3 study evaluated the pharmacokinetics, efficacy and safety of a recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in 27 previously treated male children (1–11 years) with severe and moderately severe haemophilia B (factor IX [FIX] activity ≤2 IU/dl). All patients received routine prophylaxis once every seven days for up to 77 weeks, and treated any bleeding episodes on-demand. The mean terminal half-life of rIX-FP was 91.4 hours (h), 4.3-fold longer than previous FIX treatment and clearance was 1.11 ml/h/kg, 6.4-fold slower than previous FIX treatment. The median (Q1, Q3) annualised spontaneous bleeding rate was 0.00 (0.00, 0.91) and was similar between the <6 years and ≥6 years age groups, with a weekly median prophylactic dose of 46 IU/kg. In addition, patients maintained a median trough level of 13.4 IU/dl FIX activity on weekly prophylaxis. Overall, 97.2% of bleeding episodes were successfully treated with one or two injections of rIX-FP (95% CI: 92% to 99%), 88.7% with one injection, and 96% of the treatments were rated effective (excellent or good) by the Investigator. No patient developed FIX inhibitors and no safety concerns were identified. These results indicate that rIX-FP is safe and effective for preventing and treating bleeding episodes in children with haemophilia B with weekly prophylaxis. Routine prophylaxis with rIX-FP at treatment intervals of up to 14 days are currently being investigated in children with severe and moderately severe haemophilia B. Clinicaltrials.gov (NCT01662531)
Url:
DOI: 10.1160/TH16-03-0179
PubMed: 27583313
PubMed Central: 5039316
Affiliations:
Links toward previous steps (curation, corpus...)
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Le document en format XML
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<front><div type="abstract" xml:lang="en"><title>Summary</title>
<p>A global phase 3 study evaluated the pharmacokinetics, efficacy and safety of a recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in 27 previously treated male children (1–11 years) with severe and moderately severe haemophilia B (factor IX [FIX] activity ≤2 IU/dl). All patients received routine prophylaxis once every seven days for up to 77 weeks, and treated any bleeding episodes on-demand. The mean terminal half-life of rIX-FP was 91.4 hours (h), 4.3-fold longer than previous FIX treatment and clearance was 1.11 ml/h/kg, 6.4-fold slower than previous FIX treatment. The median (Q1, Q3) annualised spontaneous bleeding rate was 0.00 (0.00, 0.91) and was similar between the <6 years and ≥6 years age groups, with a weekly median prophylactic dose of 46 IU/kg. In addition, patients maintained a median trough level of 13.4 IU/dl FIX activity on weekly prophylaxis. Overall, 97.2% of bleeding episodes were successfully treated with one or two injections of rIX-FP (95% CI: 92% to 99%), 88.7% with one injection, and 96% of the treatments were rated effective (excellent or good) by the Investigator. No patient developed FIX inhibitors and no safety concerns were identified. These results indicate that rIX-FP is safe and effective for preventing and treating bleeding episodes in children with haemophilia B with weekly prophylaxis. Routine prophylaxis with rIX-FP at treatment intervals of up to 14 days are currently being investigated in children with severe and moderately severe haemophilia B. Clinicaltrials.gov (NCT01662531)</p>
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<author><name sortKey="Key, Ns" uniqKey="Key N">NS Key</name>
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<author><name sortKey="Ljung, Lr" uniqKey="Ljung L">LR Ljung</name>
</author>
</analytic>
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<biblStruct><analytic><author><name sortKey="Goodeve, Ac" uniqKey="Goodeve A">AC Goodeve</name>
</author>
<author><name sortKey="Reitsma, Ph" uniqKey="Reitsma P">PH Reitsma</name>
</author>
<author><name sortKey="Mcvey, Jh" uniqKey="Mcvey J">JH. McVey</name>
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<biblStruct><analytic><author><name sortKey="Broderick, Cr" uniqKey="Broderick C">CR Broderick</name>
</author>
<author><name sortKey="Herbert, Rd" uniqKey="Herbert R">RD Herbert</name>
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<author><name sortKey="Latimer, J" uniqKey="Latimer J">J. Latimer</name>
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</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Autriche</li>
<li>France</li>
<li>Israël</li>
<li>Italie</li>
<li>Russie</li>
<li>États-Unis</li>
</country>
<region><li>Île-de-France</li>
</region>
<settlement><li>Paris</li>
</settlement>
</list>
<tree><country name="Israël"><noRegion><name sortKey="Kenet, Gili" sort="Kenet, Gili" uniqKey="Kenet G" first="Gili" last="Kenet">Gili Kenet</name>
</noRegion>
</country>
<country name="France"><noRegion><name sortKey="Chambost, Herve" sort="Chambost, Herve" uniqKey="Chambost H" first="Hervé" last="Chambost">Hervé Chambost</name>
</noRegion>
<name sortKey="Lambert, Thierry" sort="Lambert, Thierry" uniqKey="Lambert T" first="Thierry" last="Lambert">Thierry Lambert</name>
</country>
<country name="Autriche"><noRegion><name sortKey="Male, Christoph" sort="Male, Christoph" uniqKey="Male C" first="Christoph" last="Male">Christoph Male</name>
</noRegion>
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<country name="Allemagne"><noRegion><name sortKey="Halimeh, Susan" sort="Halimeh, Susan" uniqKey="Halimeh S" first="Susan" last="Halimeh">Susan Halimeh</name>
</noRegion>
</country>
<country name="Russie"><noRegion><name sortKey="Chernova, Tatiana" sort="Chernova, Tatiana" uniqKey="Chernova T" first="Tatiana" last="Chernova">Tatiana Chernova</name>
</noRegion>
</country>
<country name="Italie"><noRegion><name sortKey="Mancuso, Maria Elisa" sort="Mancuso, Maria Elisa" uniqKey="Mancuso M" first="Maria Elisa" last="Mancuso">Maria Elisa Mancuso</name>
</noRegion>
<name sortKey="Santagostino, Elena" sort="Santagostino, Elena" uniqKey="Santagostino E" first="Elena" last="Santagostino">Elena Santagostino</name>
</country>
<country name="Australie"><noRegion><name sortKey="Curtin, Julie" sort="Curtin, Julie" uniqKey="Curtin J" first="Julie" last="Curtin">Julie Curtin</name>
</noRegion>
</country>
<country name="États-Unis"><noRegion><name sortKey="Voigt, Christine" sort="Voigt, Christine" uniqKey="Voigt C" first="Christine" last="Voigt">Christine Voigt</name>
</noRegion>
<name sortKey="Jacobs, Iris" sort="Jacobs, Iris" uniqKey="Jacobs I" first="Iris" last="Jacobs">Iris Jacobs</name>
<name sortKey="Li, Yanyan" sort="Li, Yanyan" uniqKey="Li Y" first="Yanyan" last="Li">Yanyan Li</name>
</country>
</tree>
</affiliations>
</record>
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