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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00884390
First received: April 16, 2009
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Hemophilia A
Drug: moroctocog alfa (AF-CC) (ReFacto AF)
Procedure: Laboratory tests
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Postauthorization Safety Surveillance Study Of Patients Switching To ReFacto AF From ReFacto Or Other Factor VIII Products In Usual Care Settings

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Development of clinically significant factor VIII inhibitors [ Time Frame: 100 exposure days to study medication (approx. 2 years) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Occurence of adverse events and serious adverse events during the study [ Time Frame: Duration of participation in study ] [ Designated as safety issue: Yes ]
  • Annualized bleed rates [ Time Frame: Duration of participation in study ] [ Designated as safety issue: No ]
  • Response to first on-demand treatment with test article for all new bleeding episodes [ Time Frame: Duration of participation in study ] [ Designated as safety issue: No ]
  • number of test article infusions required for each bleeding episode [ Time Frame: Duration of participation in study ] [ Designated as safety issue: No ]
  • number of breakthrough bleeding episodes within 48 hours of a prophylaxis treatment [ Time Frame: Duration of participation in study ] [ Designated as safety issue: No ]
  • Average infusion dose and the total factor consumption [ Time Frame: Duration of participation in study ] [ Designated as safety issue: No ]
  • Incidence of less-than-expected-therapeutic effect (LETE) [ Time Frame: Duration of participation in study ] [ Designated as safety issue: No ]

Enrollment: 224
Study Start Date: May 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ReFacto AF Drug: moroctocog alfa (AF-CC) (ReFacto AF)
Providing moroctocog alfa (AF-CC) as test article for use during this study.
Procedure: Laboratory tests
Laboratory samples are collected during study visits, in order to collect safety and efficacy data related to the administration of test article.

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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884390

  Show 75 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00884390     History of Changes
Other Study ID Numbers: 3082B2-4432
Study First Received: April 16, 2009
Last Updated: April 24, 2013
Health Authority: European Union: European Medicines Agency

Keywords provided by Pfizer:
Hemophilia A

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014