Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII
NCT ID: NCT01992549
Last Updated: 2021-01-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
48 participants
INTERVENTIONAL
2014-04-30
2018-12-27
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
Exclusion Criteria
2. Concomitant treatment with any systemic immunosuppressive drug;
3. Other FVIII concentrate than Human-cl rhFVIII was received between completion visit of GENA-05 and start of GENA-15 (except emergency cases).
MALE
No
Sponsors
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Octapharma
INDUSTRY
Responsible Party
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Principal Investigators
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Sigurd Knaub, PhD
Role: STUDY_DIRECTOR
Octapharma
Locations
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UC Davis Medical Center
Sacramento, California, United States
University of Alberta
Edmonton, Alberta, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
McMaster Children's Hospital
Hamilton, Ontario, Canada
Hospital for Sick Children
Toronto, , Canada
Hopital de la Timone
Marseille, , France
Hôpital Kremlin Bicètre
Paris, , France
Institute of Hematology and Transfusiology
Tbilisi, , Georgia
Sahyadri Speciality Hospital
Pune, , India
Christian Medical College
Vellore, , India
IMSP Mother and Child Institute
Chisinau, , Moldova
University Medical School
Warsaw, , Poland
The National Children Specialized Hospital "OHMATDET"
Kiev, , Ukraine
Danylo Halytsky Lviv National Medical University
Lviv, , Ukraine
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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GENA-15
Identifier Type: -
Identifier Source: org_study_id
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