PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Hemophilia A
An Open-label, Single-arm, Post- Authorization Pragmatic Clinical Trial On The Safety And Efficacy Of Xyntha (Moroctocog-alfa (Af-cc), Recombinant Fviii) In Subjects With Hemophilia A In Usual Care Settings In China
2 other identifiers
interventional
85
1 country
15
Brief Summary
An open-label, single-arm, post- authorization pragmatic clinical trial on the safety and efficacy of Xyntha (Moroctocog-alfa (AF-CC), Recombinant FVIII) in subjects with hemophilia A in usual care settings in China for approximately 6 months or or approximately 50 exposure days whichever occurs first
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2015
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedFirst Posted
Study publicly available on registry
July 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
April 4, 2017
CompletedApril 4, 2017
February 1, 2017
1.3 years
March 19, 2015
December 19, 2016
February 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Factor VIII (FVIII) Inhibitors
Percentage of participants with the product medically important event (MIE) (FVIII inhibitor development during the study).
From Day 1 up to 28 calendar days after End of Treatment (participants had received treatment for 6 months or when participants had achieved 50 exposure days [EDs] whichever occurred first).
Secondary Outcomes (10)
Number of Participants With All Causality Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
From Day 1 up to 28 calendar days after End of Treatment (participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first).
Response Assessment of On-Demand Treatment of Bleeds
From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first.
Number of Infusions Needed to Treat Each New Bleed for On-Demand Treatment
From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first.
Frequency of Xyntha Infusions to Treat Each New Bleed for On-Demand Group
From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first.
Hemostatic Efficacy for Surgical Prophylaxis Treatment
From day of surgery to postoperative period (at least 1-3 days post operation or until adequate wound healing for minor surgery or 4-6 days post operation or until threat resolved or adequate wound healing for major surgery)
- +5 more secondary outcomes
Study Arms (1)
Intravenous infusions of Xyntha
EXPERIMENTALEnrolled 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
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.
Eligibility Criteria
You may qualify if:
- Male and/or Female subjects with Hemophilia A.
- 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.
You may not qualify if:
- Presence of any other bleeding disorder in addition to hemophilia A.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (15)
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Department of Hematology,The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Department of Hematology,Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006, China
Blood Center of Shandong Province
Jinan, Shandong, 250014, China
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, 610073, China
Blood Diseases Hospital, Chinese Academy of Medical Science (Institute of Hematology)
Tianjin, Tianjin Municipality, 300020, China
Department of Hematology,The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
Beijing Children's hospital
Beijing, 100045, China
The second affiliated hospital of chongqing medical university
Chongqing, 400010, China
Children's Hospital of Chongqing Medical University
Chongqing, 400014, China
Hematology Department, Nanfang Hospital, Southern Medical University
Guangzhou, 510515, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine/Hematology Department
Shanghai, 200025, China
Department of Hematology/Children's Hospital of Shanghai
Shanghai, 200040, China
Related Publications (1)
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.
PMID: 33269010DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2015
First Posted
July 9, 2015
Study Start
April 1, 2015
Primary Completion
July 1, 2016
Study Completion
August 1, 2016
Last Updated
April 4, 2017
Results First Posted
April 4, 2017
Record last verified: 2017-02