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Post-Marketing Surveillance To Observe Safety And Efficacy Of Xyntha Solofuse Prefilled Syringe

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Congenital Factor VIII Deficiency, Congenital Factor 8 Deficiency, Autosomal Hemophilia A, Classic Hemophilia, Congenital 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

To be eligible to enroll in this study, the study subjects will have to meet all the
following inclusion criteria:

1. Hemophilia A (congenital factor VIII deficiency) patients who have been administered
according to the indication of the product 1) Control and prevention of bleeding
episodes and for routine and surgical prophylaxis in patients with hemophilia A
(congenital factor VIII deficiency) 2) This drug does not contain von Willebrand
factor and, therefore, is not indicated in von Willebrand's disease

2. Those who have been administered the Xyntha Solofuse prefilled syringe at least once -

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

Patients who satisfy the following criteria are not included in the study according to the
local labeling:

1. Patients who have a history of hypersensitivity to the Xyntha Solofuse prefilled
syringe or the ingredients of this drug.

2. Patients who have a history of hypersensitivity to hamster proteins.

3. Patients who have bleeding disorders other than hemophilia A.

4. Patients who have a history of FVIII inhibitors, or currently have or are suspected of
having FVIII inhibitors. In case inhibitor titers quantified in Bethesda Units in the
laboratory test results are within the normal laboratory range or at least 0.6 BU/mL.
If laboratory tests cannot be performed, the investigator will determine whether or
not inhibitors exist based on the clinical assessment results that show a decrease in
efficacy of the replacement of FVIII (e.g. bleeding at least once, if the replacement
of anti-bleeding agents is needed to be administered, and if frequency or dosage of
replacement FVIII therapy needs to be increased).

5. Use of immunomodulatory therapy. (e.g. intravenous injection of immunoglobulin, use of
regular systemic corticosteroids, cyclosporine, and mediators of anti-TNF-?)

NCT03034044
Pfizer
Completed
Post-Marketing Surveillance To Observe Safety And Efficacy Of Xyntha Solofuse Prefilled Syringe

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Post-Marketing Surveillance To Observe Safety And Efficacy Of Xyntha Solofuse Prefilled Syringe
Post-marketing Surveillance To Observe Safety And Efficacy Of Xyntha Solofuse Prefilled Syringe

This study aims to observe the safety and efficacy of the Xyntha Solofuse prefilled syringe in the setting of routine practice. The primary objective is to detect medically significant events (factor VIII inhibitor). The secondary objective is to observe the overall efficacy and safety of the Xyntha Solofuse prefilled syringe including serious adverse events. In this open-label, non-comparative, observational, non-interventional, retrospective and multi-center study, post-marketing surveillance data will be collected retrospectively for up to 6 months from the initial administration day of the Xyntha Solofuse prefilled syringe injected into patients who have been administered the Xyntha Solofuse prefilled syringe.

As specified in the product approval issued by the Ministry of Food and Drug Safety, the study will be conducted for 4 years from the approval date. At least 600 study subjects will be enrolled in this study to meet the MFDS requirements. Although 600 is the assigned number of study subjects, the number of cases will be adjusted considering the actual number of enrolled subjects after the study start day.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
The study population is Hemophilia A (congenital factor VIII deficiency) patients who have been administered the Xyntha Solofuse prefilled syringe (as part of routine treatment at the Korean health care canter which has certified investigators).
  • Factor VIII Deficiency, Congenital
  • Factor 8 Deficiency, Congenital
  • Autosomal Hemophilia A
  • Classic Hemophilia
  • Hemophilia A, Congenital
Not Provided
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2
December 31, 2017
December 31, 2017   (Final data collection date for primary outcome measure)

-. Inclusion criteria

To be eligible to enroll in this study, the study subjects will have to meet all the following inclusion criteria:

  1. Hemophilia A (congenital factor VIII deficiency) patients who have been administered according to the indication of the product 1) Control and prevention of bleeding episodes and for routine and surgical prophylaxis in patients with hemophilia A (congenital factor VIII deficiency) 2) This drug does not contain von Willebrand factor and, therefore, is not indicated in von Willebrand's disease
  2. Those who have been administered the Xyntha Solofuse prefilled syringe at least once - Exclusion criteria

Patients who satisfy the following criteria are not included in the study according to the local labeling:

  1. Patients who have a history of hypersensitivity to the Xyntha Solofuse prefilled syringe or the ingredients of this drug.
  2. Patients who have a history of hypersensitivity to hamster proteins.
  3. Patients who have bleeding disorders other than hemophilia A.
  4. Patients who have a history of FVIII inhibitors, or currently have or are suspected of having FVIII inhibitors. In case inhibitor titers quantified in Bethesda Units in the laboratory test results are within the normal laboratory range or at least 0.6 BU/mL. If laboratory tests cannot be performed, the investigator will determine whether or not inhibitors exist based on the clinical assessment results that show a decrease in efficacy of the replacement of FVIII (e.g. bleeding at least once, if the replacement of anti-bleeding agents is needed to be administered, and if frequency or dosage of replacement FVIII therapy needs to be increased).
  5. Use of immunomodulatory therapy. (e.g. intravenous injection of immunoglobulin, use of regular systemic corticosteroids, cyclosporine, and mediators of anti-TNF-?)
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT03034044
B1831086
Not Provided
Not Provided
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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