A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B
NCT ID: NCT01662531
Last Updated: 2016-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
27 participants
INTERVENTIONAL
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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rIX-FP
Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) will be administered by IV infusion as routine weekly prophylaxis and episodic treatment for bleeding episodes.
rIX-FP
Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP)
Interventions
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rIX-FP
Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP)
Eligibility Criteria
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Inclusion Criteria
* Severe hemophilia B (Factor IX \[FIX\] activity of ≤ 2%).
* Body weight ≥ 10 kg.
* Subjects who have received FIX products (plasma-derived and/or recombinant FIX) for \> 150 exposure days (EDs) (6 to \< 12 years), and \> 50 EDs (\< 6 years).
* No history of FIX inhibitor formation, no detectable inhibitors at Screening and no family history of inhibitors against FIX.
* Written informed consent for study participation.
Exclusion Criteria
* Known congenital or acquired coagulation disorder other than congenital FIX deficiency.
* Kidney or liver disease.
* Recent life-threatening bleeding episode.
11 Years
MALE
No
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Program Director
Role: STUDY_DIRECTOR
CSL Behring
Locations
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The Royal Children's Hospital, Melbourne
Parkville, Victoria, Australia
The Children's Hospital at Westmead
Westmead, , Australia
AKH Wien (Paediatrics)
Vienna, , Austria
McMaster Children's Hospital
Hamilton, Ontario, Canada
Fakultni nemocnice Brno
Brno, , Czechia
Fakultni nemocnice Ostrava
Ostrava, , Czechia
Fakultni nemocnice Motole
Prague, , Czechia
C.R.T.H. Hopital de Bicentre (Hemophilie)
Le Kremlin-Bicentre, , France
Hospital Edouard Herriot
Lyon, , France
Hôpital d'enfants La Timone
Marseille, , France
CRC Coagulation Research Center GmbH
Duisburg/Altstadt, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Sheba Medical Center
Tel Litwinsky, , Israel
AOU Careggi
Florence, , Italy
IRCCS Ospendale Maggiore (Centro emofilia e Trombosi)
Milan, , Italy
FGU "Kirov Research Institute of Haemotology and Blood Trans)
Kirov, , Russia
H.U. La Paz
Madrid, , Spain
Countries
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References
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Alvarez-Roman MT, Merchan RD, Mellado RCR, Jimenez-Yuste V. Switching and increasing prophylaxis regimen with a genetically recombinant fusion of coagulation factor IX and albumin in haemophilia B: a case report. Curr Opin Hematol. 2023 Sep 1;30(5):175-179. doi: 10.1097/MOH.0000000000000775.
Kenet G, Chambost H, Male C, Lambert T, Halimeh S, Chernova T, Mancuso ME, Curtin J, Voigt C, Li Y, Jacobs I, Santagostino E; PROLONG-9FP Investigator Study Group. Long-acting recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in children. Results of a phase 3 trial. Thromb Haemost. 2016 Sep 27;116(4):659-68. doi: 10.1160/TH16-03-0179. Epub 2016 Sep 1.
Other Identifiers
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2011-006032-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CSL654_3002
Identifier Type: -
Identifier Source: org_study_id
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