Brief Title
PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Hemophilia A
Official Title
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
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
Detailed Description
The purpose of this post-approval study is to provide supplementary information relating to
the use of Xyntha (Moroctocog-alfa (AF-CC), Recombinant FVIII) in Chinese subjects with
hemophilia A, especially on the safety and efficacy in different populations of Chinese
hemophilia A patients, in particular in pediatric patients <6 years of age, pediatric
patients ≥6 to ≤12 years of age, Previously Untreated Patients (PUPs) , subjects receiving
prophylaxis treatment after enrollment in the study, and severe patients (FVIII:C <1%).
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Percentage of Participants With Factor VIII (FVIII) Inhibitors
Secondary Outcome
Number of Participants With All Causality Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Condition
Hemophilia A
Intervention
Intravenous infusions of Xyntha
Study Arms / Comparison Groups
Intravenous infusions of Xyntha
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
85
Start Date
April 2015
Completion Date
August 2016
Primary Completion Date
July 2016
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02492984
Organization ID
B1831083
Secondary IDs
2015-005040-33
Responsible Party
Sponsor
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
February 2017