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Post Marketing Surveillance To Observe Safety And Efficacy Of Xyntha® In Subjects With Hemophilia A

Last updated on November 10, 2019

FOR MORE INFORMATION
Study Location
Yonsei Rehabilitation Clinic
Guro-gu, Seoul, 152-834 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia A
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients or legally authorized representatives of pediatric patients agree to provide
written informed consent form (data privacy statement).

- Pediatric and adult patients who have been treated with Xyntha for Hemophilia A from
first approved date by KFDA, or who are planned to be newly prescribed Xyntha.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients with a known history of hypersensitivity to original or reformulated Xyntha
or any component of the product.

- Patients with a known history of hypersensitivity to hamster protein.

- Patients participating in an interventional trial of any investigational drug or
device.

NCT01790828
Pfizer
Completed
Post Marketing Surveillance To Observe Safety And Efficacy Of Xyntha® In Subjects With Hemophilia A

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Descriptive Information
Brief TitlePost Marketing Surveillance To Observe Safety And Efficacy Of Xyntha® In Subjects With Hemophilia A
Official TitlePost Marketing Surveillance To Observe Safety And Efficacy Of Xyntha 'Registered' In Subjects With Hemophilia A
Brief SummaryThis study is to describe the safety and efficacy of Xyntha® during the usual care setting.
Detailed Descriptionnon probability sample
Study TypeObservational
Study DesignTime Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationHemophilia A
ConditionHemophilia A
InterventionDrug: Xyntha : coagulation factor IIIV (recombinant)
Xyntha will be administered according to physician's discretion.
Other Name: Xyntha, MOROCTOCOG ALFA
Study Groups/CohortsXyntha group
Xyntha will be administered according to physician's discretion.
Intervention: Drug: Xyntha : coagulation factor IIIV (recombinant)
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: October 28, 2014)
42
Original Estimated Enrollment
 (submitted: February 11, 2013)
600
Actual Study Completion DateAugust 2014
Actual Primary Completion DateAugust 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients or legally authorized representatives of pediatric patients agree to provide written informed consent form (data privacy statement).
  • Pediatric and adult patients who have been treated with Xyntha for Hemophilia A from first approved date by KFDA, or who are planned to be newly prescribed Xyntha.

Exclusion Criteria:

  • Patients with a known history of hypersensitivity to original or reformulated Xyntha or any component of the product.
  • Patients with a known history of hypersensitivity to hamster protein.
  • Patients participating in an interventional trial of any investigational drug or device.
Sex/Gender
Sexes Eligible for Study:All
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesKorea, Republic of
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01790828
Other Study ID NumbersB1831078
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJuly 2015

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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