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Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemophilia A

Intervention: moroctocog alfa (AF-CC) (ReFacto AF) (Drug); Laboratory tests (Procedure)

Phase: Phase 4

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

The study will be investigating safety in patients who switch to ReFacto AF from ReFacto and other Factor VIII products.

Clinical Details

Official title: A Postauthorization Safety Surveillance Study Of Patients Switching To ReFacto AF From ReFacto Or Other Factor VIII Products In Usual Care Settings

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants With Clinically Significant Factor VIII Inhibitor Development

Secondary outcome:

Annualized Bleeding Rates (ABRs)

Response Assessment of First On-demand Treatment of New Bleeds

Number of ReFacto AF Infusions to Treat Each New Bleed

Number of Bleeding Episodes Occurring ≤48 Hours After a Prophylaxis Infusion

Number of Participants With Breakthrough Bleeds

Total Factor Consumption (TFC) Following a Non-prophylaxis Regimen at Baseline for All Participants

TFC Following a Prophylaxis Regimen at Baseline for All Participants

Average Infusion Dose

Incidence of Less-than-expected-therapeutic Effect (LETE) in the On-demand Setting

Incidence of Less-than-expected-therapeutic Effect (LETE) in the Prophylaxis Setting

Detailed description: The trial was terminated prematurely on 28 March 2013, due to the inability to recruit the planned number of subjects. The decision to terminate the trial was not based on any safety or efficacy concerns and agreement to close the study in March 2013 was agreed with EMA prior to closure activity.

Eligibility

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

Criteria:

Inclusion Criteria:

- Male patients greater than or equal to 12 years of age with severe hemophilia A

(FVIII: C less than 1%).

- Treatment history of greater than 150 EDs to prior recombinant or plasma-derived

FVIII replacement products.

- Transitioning to ReFacto AF from ReFacto or other recombinant or plasma-derived FVIII

replacement products.

- Serum albumin greater than or equal to the lower limit of normal (LLN).

- Platelet count greater than or equal to 100,000/µL.

- Prothrombin time (PT) less than or equal to1. 25 × ULN, or international normalized

ratio (INR) less than or equal to 1. 5.

- HIV positive subjects must have a CD4 count greater than 200/µL and HIV viral load

less than 200 particles/µL. Exclusion Criteria:

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

- A positive FVIII inhibitor, according to the local laboratory, at screening; or any

Bethesda Inhibitor Titer greater than 0. 6, regardless of the normal range for the testing laboratory.

- Treated with immunomodulatory therapy (including Immune Tolerance Induction [ITI])

during the screening period.

- Prior exposure to moroctocog alfa (AF-CC).

- Known hypersensitivity to hamster protein.

Locations and Contacts

Pfizer Investigational Site, Wien 1090, Austria

Pfizer Investigational Site, Brussels 1020, Belgium

Pfizer Investigational Site, Bruxelles 1200, Belgium

Pfizer Investigational Site, Leuven 3000, Belgium

Pfizer Investigational Site, Copenhagen 2100, Denmark

Pfizer Investigational Site, Helsinki 00029 HUS, Finland

Pfizer Investigational Site, Kuopio 70211, Finland

Pfizer Investigational Site, Chambray Les Tours Cedex 37170, France

Pfizer Investigational Site, Clermont Ferrand Cedex 1 63003, France

Pfizer Investigational Site, Clermont-Ferrand Cedex 1 63003, France

Pfizer Investigational Site, Le Chesnay 78157, France

Pfizer Investigational Site, Le Kremlin Bicetre Cedex 94275, France

Pfizer Investigational Site, Limoges Cedex 1 87042, France

Pfizer Investigational Site, Lyon Cedex 03 69437, France

Pfizer Investigational Site, Marseille Cedex 05 13385, France

Pfizer Investigational Site, Montmorency 95160, France

Pfizer Investigational Site, Montpellier Cedex 5 34295, France

Pfizer Investigational Site, Nantes 44093, France

Pfizer Investigational Site, Paris Cedex 15 75743, France

Pfizer Investigational Site, Berlin 10249, Germany

Pfizer Investigational Site, Bonn 53127, Germany

Pfizer Investigational Site, Bremen 28177, Germany

Pfizer Investigational Site, Dresden 01307, Germany

Pfizer Investigational Site, Frankfurt am Main 60596, Germany

Pfizer Investigational Site, Fulda 36043, Germany

Pfizer Investigational Site, Halle 06120, Germany

Pfizer Investigational Site, Hamburg 20246, Germany

Pfizer Investigational Site, Heidelberg 69123, Germany

Pfizer Investigational Site, Homburg 66421, Germany

Pfizer Investigational Site, Leipzig 04289, Germany

Pfizer Investigational Site, Leipzig 04103, Germany

Pfizer Investigational Site, Magdeburg 39112, Germany

Pfizer Investigational Site, Muenchen 80336, Germany

Pfizer Investigational Site, Muenchen 80337, Germany

Pfizer Investigational Site, Muenster 48143, Germany

Pfizer Investigational Site, Rostock 18059, Germany

Pfizer Investigational Site, Stuttgart 70176, Germany

Pfizer Investigational Site, Wiesbaden 65191, Germany

Pfizer Investigational Site, Athens 11527, Greece

Pfizer Investigational Site, Budapest 1134, Hungary

Pfizer Investigational Site, Firenze 50134, Italy

Pfizer Investigational Site, Ivrea 10015, Italy

Pfizer Investigational Site, Milano 20122, Italy

Pfizer Investigational Site, Napoli 80131, Italy

Pfizer Investigational Site, Pavia 27100, Italy

Pfizer Investigational Site, Perugia 06156, Italy

Pfizer Investigational Site, Udine 33100, Italy

Pfizer Investigational Site, Amsterdam 1105 AZ, Netherlands

Pfizer Investigational Site, Groningen 9713 GZ, Netherlands

Pfizer Investigational Site, Utrecht 3584 CX, Netherlands

Pfizer Investigational Site, Bucharest 011155, Romania

Pfizer Investigational Site, A Coruna 15006, Spain

Pfizer Investigational Site, Almeria 4009, Spain

Pfizer Investigational Site, Avila 05004, Spain

Pfizer Investigational Site, Barcelona 08035, Spain

Pfizer Investigational Site, Caceres 10003, Spain

Pfizer Investigational Site, Cadiz 11300, Spain

Pfizer Investigational Site, Granada 18012, Spain

Pfizer Investigational Site, Madrid 28046, Spain

Pfizer Investigational Site, Malaga 29010, Spain

Pfizer Investigational Site, Malaga 29011, Spain

Pfizer Investigational Site, Valencia 46009, Spain

Pfizer Investigational Site, Valladolid 47012, Spain

Pfizer Investigational Site, Zaragoza 50009, Spain

Pfizer Investigational Site, Goteborg 41345, Sweden

Pfizer Investigational Site, Malmo 205 02, Sweden

Pfizer Investigational Site, Stockholm 17176, Sweden

Pfizer Investigational Site, Manchester M13 9WL, United Kingdom

Pfizer Investigational Site, Puerto Real, Cadiz 11510, Spain

Pfizer Investigational Site, Treviso, Castelfranco Veneto 31033, Italy

Pfizer Investigational Site, Birmingham, England B4 6NH, United Kingdom

Pfizer Investigational Site, London, England NW3 2QG, United Kingdom

Pfizer Investigational Site, Palma de Mallorca, Islas Baleares 07010, Spain

Pfizer Investigational Site, Edinburgh, Scotland EH3 9YW, United Kingdom

Pfizer Investigational Site, Bangor, Wales LL57 2PW, United Kingdom

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: May 2009
Last updated: August 20, 2014

Page last updated: August 23, 2015

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