Study Evaluating ReFacto in Hemophilia A

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NCT00038909

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1-800-718-1021
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1-800-718-1021

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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 who were or are enrolled in Study CTN 93-R833-0XX/C9741-28, and have been treated with ReFacto® during this study are eligible for participation.

- The patient (or legal guardian) must be willing to give written informed consent before any study-related procedures are performed.

- A blood sample will be collected from each patient for the purpose of this study and will be analyzed at one or both of the designated central laboratories.

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


- Any condition which, in the investigator's opinion, places the patient at undue risk.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating ReFacto in Hemophilia A
Official Title  ICMJE Factor VIII Mutation Testing Program in Previously Untreated Patients (PUPs) With Hemophilia A Participating in ReFacto® Study
Brief Summary To identify the causative mutations in previously untreated patients with hemophilia A enrolled in the ReFacto® clinical safety and efficacy study CTN 93-R833-0XX/C9741-28, using two established hemophilia mutation testing laboratories (one in Europe and one in North America).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Hemophilia A
Intervention  ICMJE Drug: BDDrFVII
Study Arms  ICMJE 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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2013)		103
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2001
Actual Primary Completion Date May 2001   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who were or are enrolled in Study CTN 93-R833-0XX/C9741-28, and have been treated with ReFacto® during this study are eligible for participation.
  • The patient (or legal guardian) must be willing to give written informed consent before any study-related procedures are performed.
  • A blood sample will be collected from each patient for the purpose of this study and will be analyzed at one or both of the designated central laboratories.

Exclusion Criteria:

  • Any condition which, in the investigator's opinion, places the patient at undue risk.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00038909
Other Study ID Numbers  ICMJE 3082A1-302
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical Monitor, MDWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP