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

NCT00884390 | Terminated Phase 4 Results

• 1 other identifier: 3082B2-4432
• Study Type: interventional
• Target: 208
• Locations: 14 countries
• Sites: 74

Brief Summary

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

Conditions

Hemophilia A

Keywords

Hemophilia A

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinically Significant Factor VIII Inhibitor Development

  Number of participants with clinically significant FVIII inhibitor development after switching from ReFacto to moroctocog alfa (AF-CC). Clinically significant inhibitors are defined as a central laboratory confirmed positive inhibitor (≥ 0.6 Bethesda unit (BU) using the Nijmegen modification of the Bethesda assay present at 2 consecutive blood draws within a 6-week interval) and within 28 days before the initial or within 28 days following the second positive FVIII inhibitor sample collection one of the following: the need for the participant to administer alternative hemostatic products in order to achieve sufficient efficacy, or ≥2 adverse event reports of decreased drug effect (or other adverse event indicating a decrease in the efficacy of the test article). The blood sample collection for these results must also be between the date of first dose of study medication and 28 days after the last dose of study medication.

  100 exposure days to study medication (approx. 2 years)

Secondary Outcomes (10)

• Annualized Bleeding Rates (ABRs)

  100 exposure days to study medication (approx. 2 years)

• Response Assessment of First On-demand Treatment of New Bleeds

  100 exposure days to study medication (approx. 2 years)

• Number of ReFacto AF Infusions to Treat Each New Bleed

  100 exposure days to study medication (approx. 2 years)

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

  100 exposure days to study medication (approx. 2 years)

• Number of Participants With Breakthrough Bleeds

  100 exposure days to study medication (approx. 2 years)

Study Arms (1)

ReFacto AF

EXPERIMENTAL

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

Interventions

moroctocog alfa (AF-CC) (ReFacto AF) DRUG

Providing moroctocog alfa (AF-CC) as test article for use during this study.

ReFacto AF

Laboratory tests PROCEDURE

Laboratory samples are collected during study visits, in order to collect safety and efficacy data related to the administration of test article.

ReFacto AF

Eligibility Criteria

• Age: 12 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (74)

Pfizer Investigational Site

Vienna, 1090, Austria

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Brussels, Belgium, 1200, Belgium

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Brussels, 1020, Belgium

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Leuven, 3000, Belgium

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Copenhagen, 2100, Denmark

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Helsinki, 00029 HUS, Finland

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Kuopio, 70211, Finland

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Chambray-lès-Tours, 37170, France

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Clermont-Ferrand, 63003, France

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Le Chesnay, 78157, France

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Le Kremlin-Bicêtre, 94275, France

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Limoges, 87042, France

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Lyon, 69437, France

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Marseille, 13385, France

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Montmorency, 95160, France

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Montpellier, 34295, France

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Nantes, 44093, France

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Paris, 75743, France

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Berlin, 10249, Germany

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Bonn, 53127, Germany

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Bremen, 28177, Germany

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Dresden, 01307, Germany

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Frankfurt am Main, 60596, Germany

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Fulda, 36043, Germany

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Halle, 06120, Germany

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Hamburg, 20246, Germany

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Heidelberg, 69123, Germany

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Homburg, 66421, Germany

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Leipzig, 04103, Germany

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Leipzig, 04289, Germany

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Magdeburg, 39112, Germany

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München, 80336, Germany

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München, 80337, Germany

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Münster, 48143, Germany

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Rostock, 18059, Germany

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Stuttgart, 70176, Germany

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Wiesbaden, 65191, Germany

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Athens, 11527, Greece

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Budapest, 1134, Hungary

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Treviso, Castelfranco Veneto, 31033, Italy

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Ivrea, Italy, 10015, Italy

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Florence, 50134, Italy

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Milan, 20122, Italy

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Napoli, 80131, Italy

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Pavia, 27100, Italy

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Perugia, 06156, Italy

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Udine, 33100, Italy

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Amsterdam, 1105 AZ, Netherlands

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Groningen, 9713 GZ, Netherlands

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Utrecht, 3584 CX, Netherlands

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Bucharest, 011155, Romania

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A Coruña, A Coruna, 15006, Spain

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Ávila, Avila, 05004, Spain

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Palma de Mallorca, Balearic Islands, 07010, Spain

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Barcelona, Barcelona, 08035, Spain

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Puerto Real, Cadiz, 11510, Spain

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Málaga, Malaga, 29010, Spain

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Madrid, Spain, 28046, Spain

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Valencia, Valencia, 46009, Spain

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Zaragoza, Zaragoza, 50009, Spain

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Almería, 4009, Spain

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Cadiz, 11300, Spain

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Cáceres, 10003, Spain

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Granada, 18012, Spain

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Málaga, 29011, Spain

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Valladolid, 47012, Spain

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Gothenburg, 41345, Sweden

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Malmo, 205 02, Sweden

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Stockholm, 17176, Sweden

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Birmingham, England, B4 6NH, United Kingdom

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London, England, NW3 2QG, United Kingdom

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Edinburgh, Scotland, EH3 9YW, United Kingdom

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Bangor, Wales, LL57 2PW, United Kingdom

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Manchester, M13 9WL, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Hemophilia A

Interventions

recombinant factor VIII SQ; Factor VIII; Clinical Laboratory Techniques

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Limitations and Caveats

The study was terminated early by agreement with the EMA before full recruitment was attained, but this is not considered to affect the overall results and the ability of the study to address its objectives.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2009
• First Posted: April 20, 2009
• Study Start: May 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: September 1, 2014
• Results First Posted: September 1, 2014

Record last verified: 2014-08

Locations

FI (2); AU (1); DE (19); HU (1); BE (3); IT (8); RO (1); SE (3); GB (5); FR (11); GR (1); DK (1); NL (3); ES (15)