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Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A

Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemophilia A

Intervention: ReFacto AF (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Medical Monitor, MD, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer

Summary

The purpose of this study is to determine the relative bioavailability of ReFacto AF as compared to ReFacto, when each is administered as 2-minute bolus infusions.

Clinical Details

Official title: A Single Dose, Randomized, Double-Blind, 2-Period Crossover Study in Patients With Hemophilia A to Evaluate the Pharmacokinetics of B-Domain Deleted Recombinant Human Factor VIII (BDDrFVIII) Manufactured by the Current Process (ReFacto) and by an Albumin Free Manufacturing Process (ReFacto AF)

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Severe hemophilia A (FVIII: C < 1% at local laboratory)

- Previously treated patients (PTP) with at least 250 exposure days to any factor VIII

product

- Age greater than or equal to 12 years\

Exclusion Criteria:

- The presence of any bleeding disorder in addition to hemophilia A

- Concomitant therapy with immunosuppressant drugs (e. g., intravenous immunoglobulin

(IVIG), routine systemic corticosteroid use)

- History of detectable factor VIII inhibitor

Locations and Contacts

Additional Information


Last updated: April 18, 2008

Page last updated: August 23, 2015

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