Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients
NCT ID: NCT01712438
Last Updated: 2021-01-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
110 participants
INTERVENTIONAL
2013-02-28
2019-12-20
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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Human cl rhFVIII
Human cl rhFVIII
Interventions
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Human cl rhFVIII
Eligibility Criteria
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Inclusion Criteria
* Severe Hemophilia A (FVIII:C \<1%)
* No previous treatment with FVIII concentrates or other blood products containing FVIII
Exclusion Criteria
* Severe liver or kidney disease
* Concomitant treatment with any systemic immunosuppressive drug
MALE
No
Sponsors
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Octapharma
INDUSTRY
Responsible Party
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Principal Investigators
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Sigurd Knaub
Role: STUDY_DIRECTOR
Octapharma
Locations
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UC Davis
Sacramento, California, United States
All Children's Hospital
St. Petersburg, Florida, United States
Harvard Children's Hospital Boston
Boston, Massachusetts, United States
Republican Scientific Practical Center for Pediatric Oncology and Hematology
Minsk, , Belarus
University of Alberta
Edmonton, Alberta, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
Mc Master Children's Hospital
Hamilton, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Hopital Ste-Justine
Montreal, Quebec, Canada
L'hôpital Côte de Nacre - CHU de Caen
Caen, , France
Centre de traitement de l'hemophilie, Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
Hopital de la Timone
Marseille, , France
Hôtel-Dieu de Nantes, Centre Regional de Traitement de l'hemophilie
Nantes, , France
Hôpital Necker
Paris, , France
CHU de Rennes - Hôpital Pontchaillou
Rennes, , France
Hopital Trousseau - CHU Tours
Tours, , France
Institute of Haematology and Transfusiology
Tbilisi, , Georgia
Institut für Experimentelle Hämatologie und Transfusionsmedizin (IHT)
Bonn, , Germany
University Hospital Frankfurt/M
Frankfurt, , Germany
Universitätsmedizin der Johannes-Gutenberg-Universität Mainz
Mainz, , Germany
Kasturba Medical College, Dr. TMA Pai Hospital
Manipal, Karnataka, India
Sahyadri Speciality Hospital, Haematology & BMT Unit
Pune, , India
Christian Medical College & Hospital, Dept of Haematology
Vellore, , India
Univ. Di Perugia
Perugia, , Italy
Centro di Referimento per le Malattie Emorragiche e Trombotiche
Torino, , Italy
Scientific Research Institute of Mother and Child Health Care
Chisinau, , Moldova
Centre Hospitalier Ibn Sina
Rabat, , Morocco
University Medical School Warsaw
Warsaw, , Poland
HSJ - Hospital de São João, EPE
Porto, , Portugal
Morozovsky Children's Hospital
Moscow, , Russia
Haemophilia Centre, University Clinical Centre
Ljubljana, , Slovenia
Unitat d'hemofilia, Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
National Children's Specialized Hospital "OHMATDET"
Kiev, , Ukraine
Institute of Blood Pathology and Transfusion Medicine
Lviv, , Ukraine
Cambridge University Hospital
Cambridge, , United Kingdom
Great Ormond Street Hospital for Children
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2012-002554-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GENA-05
Identifier Type: -
Identifier Source: org_study_id
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