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:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00884390
First received: April 16, 2009
Last updated: April 24, 2013
Last verified: April 2013
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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:
Genetics Home Reference related topics:
hemophilia
MedlinePlus related topics:
Hemophilia
U.S. FDA Resources
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00884390
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| Austria | |
| Pfizer Investigational Site | |
| Wien, Austria, 1090 | |
| Belgium | |
| Pfizer Investigational Site | |
| Brussels, Belgium, 1020 | |
| Pfizer Investigational Site | |
| Bruxelles, Belgium, 1200 | |
| Pfizer Investigational Site | |
| Leuven, Belgium, 3000 | |
| Denmark | |
| Pfizer Investigational Site | |
| Copenhagen, Denmark, 2100 | |
| Finland | |
| Pfizer Investigational Site | |
| Helsinki, Finland, 00029 HUS | |
| Pfizer Investigational Site | |
| Kuopio, Finland, 70211 | |
| France | |
| Pfizer Investigational Site | |
| Chambray Les Tours Cedex, France, 37170 | |
| Pfizer Investigational Site | |
| Clermont Ferrand Cedex 1, France, 63003 | |
| Pfizer Investigational Site | |
| Clermont-Ferrand Cedex 1, France, 63003 | |
| Pfizer Investigational Site | |
| Le Chesnay, France, 78157 | |
| Pfizer Investigational Site | |
| Le Kremlin Bicetre Cedex, France, 94275 | |
| Pfizer Investigational Site | |
| Limoges Cedex 1, France, 87042 | |
| Pfizer Investigational Site | |
| Lyon Cedex 03, France, 69437 | |
| Pfizer Investigational Site | |
| Marseille Cedex 05, France, 13385 | |
| Pfizer Investigational Site | |
| Montmorency, France, 95160 | |
| Pfizer Investigational Site | |
| Montpellier Cedex 5, France, 34295 | |
| Pfizer Investigational Site | |
| Nantes, France, 44093 | |
| Pfizer Investigational Site | |
| Paris Cedex 15, France, 75743 | |
| Germany | |
| Pfizer Investigational Site | |
| Berlin, Germany, 10249 | |
| Pfizer Investigational Site | |
| Bonn, Germany, 53127 | |
| Pfizer Investigational Site | |
| Bremen, Germany, 28177 | |
| Pfizer Investigational Site | |
| Dresden, Germany, 01307 | |
| Pfizer Investigational Site | |
| Frankfurt am Main, Germany, 60596 | |
| Pfizer Investigational Site | |
| Fulda, Germany, 36043 | |
| Pfizer Investigational Site | |
| Halle, Germany, 06120 | |
| Pfizer Investigational Site | |
| Hamburg, Germany, 20246 | |
| Pfizer Investigational Site | |
| Heidelberg, Germany, 69123 | |
| Pfizer Investigational Site | |
| Homburg, Germany, 66421 | |
| Pfizer Investigational Site | |
| Leipzig, Germany, 04103 | |
| Pfizer Investigational Site | |
| Leipzig, Germany, 04289 | |
| Pfizer Investigational Site | |
| Magdeburg, Germany, 39112 | |
| Pfizer Investigational Site | |
| Muenchen, Germany, 80337 | |
| Pfizer Investigational Site | |
| Muenchen, Germany, 80336 | |
| Pfizer Investigational Site | |
| Muenster, Germany, 48143 | |
| Pfizer Investigational Site | |
| Rostock, Germany, 18059 | |
| Pfizer Investigational Site | |
| Stuttgart, Germany, 70176 | |
| Pfizer Investigational Site | |
| Wiesbaden, Germany, 65191 | |
| Greece | |
| Pfizer Investigational Site | |
| Athens, Greece, 11527 | |
| Hungary | |
| Pfizer Investigational Site | |
| Budapest, Hungary, 1134 | |
| Italy | |
| Pfizer Investigational Site | |
| Treviso, Castelfranco Veneto, Italy, 31033 | |
| Pfizer Investigational Site | |
| Firenze, Italy, 50134 | |
| Pfizer Investigational Site | |
| Ivrea, Italy, 10015 | |
| Pfizer Investigational Site | |
| Milano, Italy, 20122 | |
| Pfizer Investigational Site | |
| Napoli, Italy, 80131 | |
| Pfizer Investigational Site | |
| Pavia, Italy, 27100 | |
| Pfizer Investigational Site | |
| Perugia, Italy, 06156 | |
| Pfizer Investigational Site | |
| Udine, Italy, 33100 | |
| Netherlands | |
| Pfizer Investigational Site | |
| Amsterdam, Netherlands, 1105 AZ | |
| Pfizer Investigational Site | |
| Groningen, Netherlands, 9713 GZ | |
| Pfizer Investigational Site | |
| Utrecht, Netherlands, 3584 CX | |
| Romania | |
| Pfizer Investigational Site | |
| Bucharest, Romania, 011155 | |
| Spain | |
| Pfizer Investigational Site | |
| Puerto Real, Cadiz, Spain, 11510 | |
| Pfizer Investigational Site | |
| Palma de Mallorca, Islas Baleares, Spain, 07010 | |
| Pfizer Investigational Site | |
| A Coruna, Spain, 15006 | |
| Pfizer Investigational Site | |
| Almeria, Spain, 4009 | |
| Pfizer Investigational Site | |
| Avila, Spain, 05004 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08035 | |
| Pfizer Investigational Site | |
| Caceres, Spain, 10003 | |
| Pfizer Investigational Site | |
| Cadiz, Spain, 11300 | |
| Pfizer Investigational Site | |
| Granada, Spain, 18012 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28046 | |
| Pfizer Investigational Site | |
| Malaga, Spain, 29010 | |
| Pfizer Investigational Site | |
| Malaga, Spain, 29011 | |
| Pfizer Investigational Site | |
| Valencia, Spain, 46009 | |
| Pfizer Investigational Site | |
| Valladolid, Spain, 47012 | |
| Pfizer Investigational Site | |
| Zaragoza, Spain, 50009 | |
| Sweden | |
| Pfizer Investigational Site | |
| Goteborg, Sweden, 41345 | |
| Pfizer Investigational Site | |
| Malmo, Sweden, 205 02 | |
| Pfizer Investigational Site | |
| Stockholm, Sweden, 17176 | |
| United Kingdom | |
| Pfizer Investigational Site | |
| Birmingham, England, United Kingdom, B4 6NH | |
| Pfizer Investigational Site | |
| London, England, United Kingdom, NW3 2QG | |
| Pfizer Investigational Site | |
| Edinburgh, Scotland, United Kingdom, EH3 9YW | |
| Pfizer Investigational Site | |
| Bangor, Wales, United Kingdom, LL57 2PW | |
| Pfizer Investigational Site | |
| Manchester, United Kingdom, M13 9WL | |
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 June 17, 2013