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Study of Safety And Efficacy Of ReFacto AF In Previously Untreated Hemophilia A Patients In The Usual Care Setting

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
CHU de Nantes
Nantes, , 44093 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia A
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-6
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male subjects records, including newborns.

- No prior exposure to factor products or any blood products.

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

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

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

- Any condition(s) that compromises the ability to collect study-related observations,
or that poses a contraindication to study participation (these conditions include, but
are not limited to, inadequate medical history to assure study eligibility; and
expectation of poor adherence to study requirements).

NCT00950170
Pfizer
Completed
Study of Safety And Efficacy Of ReFacto AF In Previously Untreated Hemophilia A Patients In The Usual Care Setting

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Study of Safety And Efficacy Of ReFacto AF In Previously Untreated Hemophilia A Patients In The Usual Care Setting
An Open-label Study Of The Safety And Efficacy Of Refacto Af In Previously Untreated Patients In Usual Care Settings
Study to evaluate the safety and effectiveness of ReFacto AF for the treatment of severe hemophilia A in patients who have not yet received treatment for their hemophilia. Study subjects will be males less than 6 years old who have not taken any clotting factor or other blood products before the study. The safety and effectiveness of ReFacto AF will be determined in this study by tests and procedures done at the doctor's office.
Regulatory Commitment
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Hemophilia A
Procedure: Laboratory Tests
Blood draws to determine the level of factor VIII activity before and after dosing at appropriate visits, and blood draws to determine levels of factor VIII inhibitor (antibody to factor VIII).
Other Name: ReFacto AF
Experimental: 1
The investigator treats subjects with ReFacto AF in the usual care setting.
Intervention: Procedure: Laboratory Tests
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
November 2016
November 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male subjects <6 years of age with severe hemophilia A (FVIII:C <1%) based on clinical records, including newborns.
  • No prior exposure to factor products or any blood products.

Exclusion Criteria:

  • Presence of any bleeding disorder in addition to hemophilia A.
  • Treatment with any investigational agent or device within the past 30 days.
  • Any condition(s) that compromises the ability to collect study-related observations, or that poses a contraindication to study participation (these conditions include, but are not limited to, inadequate medical history to assure study eligibility; and expectation of poor adherence to study requirements).
Sexes Eligible for Study: Male
up to 6 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Italy,   Netherlands,   Spain,   Turkey,   Ukraine
Austria,   Georgia,   Greece,   Poland,   Romania,   Sweden
 
NCT00950170
3082B2-4434
B1831006 ( Other Identifier: Alias Study Number )
2008-008436-93 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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.

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