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

NCT03034044

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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-α)

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Congenital Factor VIII Deficiency, Congenital Factor 8 Deficiency, Autosomal Hemophilia A, Classic Hemophilia, Congenital Hemophilia APost-Marketing Surveillance To Observe Safety And Efficacy Of Xyntha Solofuse Prefilled Syringe
NCT03034044
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Post-Marketing Surveillance To Observe Safety And Efficacy Of Xyntha Solofuse Prefilled Syringe
Official Title POST-MARKETING SURVEILLANCE TO OBSERVE SAFETY AND EFFICACY OF XYNTHA SOLOFUSE PREFILLED SYRINGE
Brief Summary

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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).
Condition
  • Factor VIII Deficiency, Congenital
  • Factor 8 Deficiency, Congenital
  • Autosomal Hemophilia A
  • Classic Hemophilia
  • Hemophilia A, Congenital
Intervention Not Provided
Study Groups/Cohorts Not Provided
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 Status Completed
Actual Enrollment
 (submitted: January 7, 2019)
106
Original Estimated Enrollment
 (submitted: January 24, 2017)
600
Actual Study Completion Date January 17, 2018
Actual Primary Completion Date January 17, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

-. 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-?)
Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03034044
Other Study ID Numbers B1831086
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2019