PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Hemophilia A
NCT02492984
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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Adult Trials: 18+ Years
- 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.
- 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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Hemophilia A | |||
| Official Title ICMJE | 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 Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Hemophilia A | |||
| Intervention ICMJE | Drug: 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 Name: Xyntha (Moroctocog-alfa (AF-CC) | |||
| Study Arms ICMJE | Experimental: 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. Intervention: Drug: Intravenous infusions of Xyntha | |||
| Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 85 | |||
| Original Estimated Enrollment ICMJE | 90 | |||
| Actual Study Completion Date ICMJE | August 2016 | |||
| Actual Primary Completion Date | July 2016 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | Child, Adult, Older Adult | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | China | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT02492984 | |||
| Other Study ID Numbers ICMJE | B1831083 2015-005040-33 ( EudraCT Number ) | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | February 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||