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Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) with Advate (FLrFVIII) in Hemophilia A - Article


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Antihemophilic Factor (Human or Recombinant)

Advate; AHF (Human); AHG; Alphanate; Factor VIII; Hemofil M; Humate-P; Koate DVI; Koate-HP; Kogenate FS; Monarc-M; Monoclate-P; Profilate HP; ReFacto



Clinical Trial: Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) with Advate (FLrFVIII) in Hemophilia A

This study is currently recruiting patients.
Verified by Wyeth August 2005

Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00141843

Purpose

The study will consist of two parts: a safety and efficacy period in which all subjects will participate and a pharmacokinetic analysis period, in which 30 eligible subjects will participate to compare ReFacto AF and Advate bioequivalency and safety and efficacy of ReFacto AF in patients with Hemophilia A.
Condition Intervention Phase
Hemophilia A
  Gene Transfer: ReFacto AF
 Gene Transfer: B-Domain deleted Recombinant Factor VIII
 Gene Transfer: BDDrFVIII
 Phase III

MedlinePlus related topics:  Hemophilia

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study

Official Title: A Randomized Two-Way Blinded Crossover-Design Study to Establish the Bioequivalence of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII,Refacto AF) with a Full Length Recombinant Factor VIII Preparation (FLrFVIII,Advate), Followed by an Open-Label Trial of the Safety and Efficacy of ReFacto AF in Previously Treated Patients with Hemophilia A.

Further Study Details: 
Primary Outcomes: To determine the incidence rate of Factor VIII inhibitors in the study patient population.To establish bioequivalence of ReFacto AF as compared to Advate using the one stage Factor VIII activity assay.
Secondary Outcomes: To characterize the efficacy of ReFActo AF in preventing and treating bleeding episodes during prophylaxis.To characterize PK of ReFacto AF as compared to Advate over time.
Expected Total Enrollment:  100

Study start: July 2005

Eligibility

Ages Eligible for Study:  12 Years and above,  Genders Eligible for Study:  Male
Criteria

Inclusion Criteria:

  • Male subjects with severe or moderately severe hemophilia A
  • A negative past medical history of a Factor VIII inhibitor
  • Age greater than or equal to 12 years

Exclusion Criteria:

  • A history of Factor VIII inhibitors
  • Presence of a bleeding disorder in addition to hemophilia
  • Known hypersensitivity to hampster protein

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00141843

Trial Manager       clinicaltrialinfo@wyeth.com

Australia
      Perth,  6000,  Australia; Not yet recruiting
  see Central Contact 

Belgium
      Leuven,  3000,  Belgium; Not yet recruiting
  see Central Contact 

Finland
      Helsinki,  00029,  Finland; Not yet recruiting
  see Central Contact 

France
      Le Kremlin Bicêtre,  94275,  France; Not yet recruiting
  see Central Contact 

      Rouen,  76031,  France; Not yet recruiting
  see Central Contact 

Germany
      Muenster,  48143,  Germany; Not yet recruiting
  see Central Contact 

      Berlin,  10249,  Germany; Not yet recruiting
  see Central Contact 

Hungary
      Budapest,  H-1135,  Hungary; Recruiting
  see Central Contact 

Italy
      Milano,  20122,  Italy; Not yet recruiting
  see Central Contact 

Netherlands
      Groningen,  Netherlands; Not yet recruiting
  see Central Contact 

New Zealand
      Auckland,  New Zealand; Not yet recruiting
  see Central Contact 

      Hamilton,  New Zealand; Not yet recruiting
  see Central Contact 

Poland
      Lodz,  95-510,  Poland; Not yet recruiting
  see Central Contact 

      Poznan,  Poland; Not yet recruiting
  see Central Contact 

      Wroclaw,  Poland; Not yet recruiting
  see Central Contact 

      Warszawa,  00-576,  Poland; Not yet recruiting
  see Central Contact 

Spain
      Valencia,  46009,  Spain; Not yet recruiting
  see Central Contact 

      Madrid,  28046,  Spain; Not yet recruiting
  see Central Contact 

Sweden
      Malmö,  Sweden; Not yet recruiting
  See Central Contact 

      Stockholm,  171 76,  Sweden; Not yet recruiting
  see Central Contact 

Study chairs or principal investigators

Medical Monitor,  Study Director,  Wyeth Research   
Trial Manager,  Principal Investigator,  For Australia, China, Hong Kong, New Zealand, South Korea and Taiwan, medinfo@wyeth.com   
Trial Manager,  Principal Investigator,  For Nordic Area, Norway and Sweden, MedInfoNord@wyeth.com   
Trial Manager,  Principal Investigator,  For Poland and Ukraine, med-info-poland@wyeth.com   
Trial Manager,  Principal Investigator,  All other countries, contact clinicaltrialinfo@wyeth.com and we will send you the appropriate contact information.   

More Information

Study ID Numbers:  3082B2-310
Last Updated:  August 31, 2005
Record first received:  August 30, 2005
ClinicalTrials.gov Identifier:  NCT00141843
Health Authority: United States: Food and Drug Administration; Belgium: Institutional Review Board; France: Ministry of Health; Germany: Ethics Commission; Italy: Ministry of Health; Mali: Ministry of Health; Bulgaria: Bulgarian Drug Agency; Greece: National Organization of Medicines; Turkey: Ministry of Health; Spain: Ministry of Health; Portugal: National Pharmacy and Medicines Institute; United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health; United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health; Switzerland: Swissmedic; Israel: Israeli Health Ministry Pharmaceutical Administration; Hungary: National Institute of Pharmacy; Croatia: Ministry of Health and Social Care; Poland: Ministry of Health; Czech Republic: State Institute for Drug Control; United Kingdom: National Health Service; Australia: Human Research Ethics Committee; New Zealand: Health Research Council; Taiwan: Department of Health
ClinicalTrials.gov processed this record on 2005-09-06


Source: ClinicalTrials.gov
Cache Date: September 7, 2005

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December 3, 2008


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