You are here

Our science / Clinical Trials / Find a Trial / NCT00037544

Study Evaluating ReFacto AF in Severe Hemophilia A

Back to Search Print Save as PDF Bookmark Trial

NCT00037544

Last updated on May 11, 2018
Back to Search Print Save as PDF Bookmark Trial

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
ClinicalTri[email protected]
Related Links
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
12+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Severe hemophilia A (FVIII:C less than or equal to 2% at local laboratory)

- Previously treated patients with greater than or equal to 250 exposure days to any
Factor VIII product

- Age greater than or equal to 12 years

- History of prophylaxis dosing at least twice per week on any Factor VIII product for
at least 3 consecutive months within the 2 years prior to study enrollment unless the
patient completed the previous pharmacokinetic study

- Adequate laboratory results

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

- Concomitant therapy with immunosuppressive drugs

- Current or historical Factor VIII inhibitor

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

NCT00037544
Pfizer
Completed
Study Evaluating ReFacto AF in Severe Hemophilia A

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
Advanced Search

Similar Trials

Healthy Volunteers
Single-dose Study of [14C]Lorlatinib (PF-06463922) Metabolism In Healthy Male Volunteers
NCT03184168
Males
18+
Years
Madison, Wisconsin
Myeloid Leukemia
A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia
NCT03416179
All Genders
18+
Years
Multiple Sites
Moderate-severe Pain
Open-Label Study in Children 7-17 Years for the Treatment of Moderate to Severe Pain
NCT02101554
All Genders
7+
Years
Multiple Sites
Normal Healthy
Single Dose, Repeated Dose, and Conditional Food Effect Study of PF-05221304 in Healthy Subjects
NCT02871037
All Genders
18+
Years
New Haven, Connecticut
Study Evaluating ReFacto AF in Severe Hemophilia A
An Open-Label Study to Characterize the Safety and Efficacy of BDDrFVIII Manufactured by the Albumin Free Process (ReFacto AF) in the Treatment of Previously Treated Patients (PTP) With Severe Hemophilia A
To characterize the safety and efficacy of ReFacto AF in treating acute bleeding episodes during prophylaxis treatment, including neoantigenicity.
Not Provided
Interventional
Phase 3
Primary Purpose: Treatment
Hemophilia A
Drug: ReFacto AF
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
August 2004
August 2004   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Severe hemophilia A (FVIII:C less than or equal to 2% at local laboratory)
  • Previously treated patients with greater than or equal to 250 exposure days to any Factor VIII product
  • Age greater than or equal to 12 years
  • History of prophylaxis dosing at least twice per week on any Factor VIII product for at least 3 consecutive months within the 2 years prior to study enrollment unless the patient completed the previous pharmacokinetic study
  • Adequate laboratory results

Exclusion Criteria:

  • Presence of any bleeding disorder in addition to hemophilia A
  • Concomitant therapy with immunosuppressive drugs
  • Current or historical Factor VIII inhibitor
  • Treatment with any investigational drug or device within the past 30 days
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00037544
3082B1-306
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
April 2008

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now