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Efficacy & Safety of REFACTO AF in Prophylaxis Treatment

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NCT02718677

Last updated on July 31, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Severe Hemophilia A
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
1-18 year
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Male subjects with severe hemophilia A (FVIII:C

2. Age from 1 to 18 years

3. Previously untreated patients (PUPs) or previously treated patients (PTPs) with factor
VIII

4. No previous history of FVIII inhibitors

5. Legally authorized representatives of pediatric patients agree to provide written
informed consent form

6. Patients who are scheduled by their hematologist to initiate prophylaxis with ReFacto
AF or to continue previously initiated prophylaxis with ReFacto AF, including patients
who are switching from prophylaxis with another FVIII product to ReFacto AF.

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

1. Subject has known hypersensitivity to the active substance or any of the excipients.

2. Subject has known allergic reaction to hamster proteins

3. Presence of any bleeding disorder in addition to hemophilia A.

4. Treatment with any investigational agent or device within the past 30 days.

5. Any other contraindications according to Summary of Product Characteristics

6. Unsuitable to participate in study for any other reason as assessed by investigator

NCT02718677
Pfizer
Not yet recruiting
Efficacy & Safety of REFACTO AF in Prophylaxis Treatment

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Pfizer Clinical Trials Contact Center

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[email protected]

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Efficacy & Safety of REFACTO AF in Prophylaxis Treatment
Non-interventional Study To Evaluate Efficacy And Safety Of Refacto Af In The Standard Prophylaxis Treatment Of Children With Severe Hemophilia A
This NIS aims to evaluate the efficacy and the safety of ReFacto AF in the Standard Prophylaxis Treatment of children with severe hemophilia A in Romania

Patients receiving standard prophylaxis treatment with ReFacto AF as determined by the inclusion criteria will be included in the study. During this observational study, patients diagnosed with severe hemophilia A, and starting or continuing prophylaxis with ReFacto AF as per local standard clinical care, will be observed for 12 months. Patients who received prophylaxis with another FVIII product and are scheduled to switch to ReFacto AF prophylaxis can also be enrolled. Physician decision to initiate or to continue ReFacto AF prophylaxis therapy will be independent and it will precede subjects' inclusion in the study. Also the physician decision to switch the prophylaxis with another FVIII product to ReFacto AF will be independent and it will precede subjects' inclusion in the study. Detailed information on hemophilia A history and previous hemophilia treatments will be collected at Baseline. The number of bleedings and their treatment, status of joints and the quality of life will be assessed at 3, 6, 9 and 12 months after ReFacto AF prophylaxis initiation.

ReFacto AF dosing and treatment duration are at the discretion of the investigator in accordance with local clinical practice and local labeling. All clinical or laboratory assessments in this study will be conducted as per current medical practice in management of hemophilia A without any study related procedures.
Observational
Observational Model: Other
Time Perspective: Other
Not Provided
Not Provided
Non-Probability Sample
Children with severe hemophilia A who are scheduled by their hematologist to initiate prophylaxis with ReFacto AF or to continue previously initiated prophylaxis with ReFacto AF, including patients who are switching from prophylaxis with another FVIII product to ReFacto AF
Severe Hemophilia A
Drug: Refacto
Observational - Non-Interventional Study
Other Name: moroctocog alfa
1. Refacto (NIS)
Non-Interventional Study
Intervention: Drug: Refacto
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
33
April 1, 2020
April 1, 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male subjects with severe hemophilia A (FVIII:C <1%)
  2. Age from 1 to 18 years
  3. Previously untreated patients (PUPs) or previously treated patients (PTPs) with factor VIII
  4. No previous history of FVIII inhibitors
  5. Legally authorized representatives of pediatric patients agree to provide written informed consent form
  6. Patients who are scheduled by their hematologist to initiate prophylaxis with ReFacto AF or to continue previously initiated prophylaxis with ReFacto AF, including patients who are switching from prophylaxis with another FVIII product to ReFacto AF.

Exclusion Criteria:

  1. Subject has known hypersensitivity to the active substance or any of the excipients.
  2. Subject has known allergic reaction to hamster proteins
  3. Presence of any bleeding disorder in addition to hemophilia A.
  4. Treatment with any investigational agent or device within the past 30 days.
  5. Any other contraindications according to Summary of Product Characteristics
  6. Unsuitable to participate in study for any other reason as assessed by investigator
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
1 Year to 18 Years   (Child, Adult)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT02718677
B1831088
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
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
November 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

BY EMAIL

Contact

[email protected]



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