PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Hemophilia A
NCT ID: NCT02492984
Last Updated: 2017-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
85 participants
INTERVENTIONAL
2015-04-30
2016-08-31
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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Intravenous infusions of Xyntha
Enrolled subjects will be treated with intravenous infusions of Xyntha for: • On-Demand treatment, • Surgical Prophylaxis at a dose and frequency prescribed by the subject's treating physician in accordance with the Xyntha label and will be adjusted solely according to medical and therapeutic necessity.
Intravenous infusions of Xyntha
Enrolled subjects will be treated with intravenous infusions of Xyntha for: • On-Demand treatment, • Surgical Prophylaxis at a dose and frequency prescribed by the subject's treating physician in accordance with the Xyntha label and will be adjusted solely according to medical and therapeutic necessity.
Interventions
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Intravenous infusions of Xyntha
Enrolled subjects will be treated with intravenous infusions of Xyntha for: • On-Demand treatment, • Surgical Prophylaxis at a dose and frequency prescribed by the subject's treating physician in accordance with the Xyntha label and will be adjusted solely according to medical and therapeutic necessity.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects/parents/legal representatives must be able to comply with registry procedures (informed consent/assent process, clinical visits, reporting of infusion and bleed data, reporting of adverse events, etc).
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative, parent(s)/legal guardian) has been informed of all pertinent aspects of the study.
Exclusion Criteria
* Treatment with immunomodulatory therapy (e.g., intravenous immunoglobulin, routine systemic corticosteroids, cyclosporins, anti-TNF agents) within 30 days prior to study entry or planned use for the duration of their study participation.
* Subjects with a past history of, or current factor VIII inhibitor. For laboratory-based assessments, any Bethesda inhibitor titer greater than the laboratory's normal range or ≥0.6 BU/mL.
* Subjects with known hypersensitivity to the active substance or to any of the excipients of Xyntha.
* Subjects with a known hypersensitivity to Chinese Hamster Ovary cell proteins.
* Unwilling or unable to follow the terms of the protocol.
* Any condition which may compromise the subject's ability to comply with and/or perform study-related activities or that poses a clinical contraindication to study participation (these conditions include, but are not limited to, inadequate medical history to assure study eligibility; expectation of poor compliance in provision of observations for study-related documentation), in the opinion of the Investigator.
* Participation in other studies involving investigational drug(s) (Phases 1-4) within 30 days before the current study begins and/or during study participation (exception for studies on Xyntha).
* Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Department of Hematology,The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Department of Hematology,Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Blood Center of Shandong Province
Jinan, Shandong, China
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, China
Blood Diseases Hospital, Chinese Academy of Medical Science (Institute of Hematology)
Tianjin, Tianjin Municipality, China
Department of Hematology,The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Beijing Children's hospital
Beijing, , China
The second affiliated hospital of chongqing medical university
Chongqing, , China
Children's Hospital of Chongqing Medical University
Chongqing, , China
Hematology Department, Nanfang Hospital, Southern Medical University
Guangzhou, , China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine/Hematology Department
Shanghai, , China
Department of Hematology/Children's Hospital of Shanghai
Shanghai, , China
Countries
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References
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Yang R, Zhao Y, Wang X, Sun J, Wu R, Jin C, Jin J, Wu D, Rendo P, Sun F, Rupon J, Huard F, Korth-Bradley JM, Xu L, Luo B, Liu YC. Safety and Efficacy of Moroctocog Alfa (AF-CC) in Chinese Patients with Hemophilia A: Results of Two Open-Label Studies. J Blood Med. 2020 Nov 25;11:439-448. doi: 10.2147/JBM.S241605. eCollection 2020.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2015-005040-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B1831083
Identifier Type: -
Identifier Source: org_study_id
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