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NCT00168051 Clinical Trial

Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A

Hemophilia A Clinical Trial

Official title:
A Single Dose, Randomized, 2-Period Crossover Study in Patients With Hemophilia A to Evaluate the Pharmacokinetics of ReFacto (B-domain Deleted Recombinant Human Factor VIII (BDDrFVIII) and Advante (a Full-length Recombinant Factor VIII (FLrFVIII)

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00168051
Other study ID # 3082A-101711
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date April 2005
Est. completion date November 2005

Study information
Verified date February 2013
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to compare the pharmacokinetic parameters of ReFacto and Advate, using the chromogenetic substrate assay to measure plasma Factor VIII activity in plasma.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date November 2005
Est. primary completion date November 2005
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

- Severe hemophilia A

- Previously treated patients with at least 150 exposure days to any Factor VIII product

Exclusion Criteria:

- Hypersensitivity to any recombinant Factor VIII product

- History of or current Factor VIII inhibitor

- Bleeding episode or other reason requiring Factor VIII treatment within 3 days of study

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ReFacto

• Advante

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Italy,  Netherlands,  New Zealand,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetic measurement of area under the plasma Factor VIII activity in plasma versus time curve for 48 hours.
Secondary Number of subjects who experience any adverse event or develop Factor VIII inhibitor at study termination, 48 hours post dosing and/or at the final study visit within seven days of the 2nd period of the study.
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