Study Evaluating Prophylaxis Treatment & Characterizing Efficacy, Safety, & PK Of B-Domain Deleted Recombinant FVIII
NCT ID: NCT00543439
Last Updated: 2019-01-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
66 participants
INTERVENTIONAL
2007-12-31
2018-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study Evaluating Safety And Efficacy Of Moroctocog Alfa (AF-CC) In Previously Treated Hemophilia A Patients
NCT00914459
Moroctocog Alfa (AF-CC) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Hemophilia A Patients
NCT04396639
Study Evaluating ReFacto AF in Severe Hemophilia A
NCT00037544
Study of Safety And Efficacy Of ReFacto AF In Previously Untreated Hemophilia A Patients In The Usual Care Setting
NCT00950170
Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
NCT00243659
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
On-Demand therapy for 6 months, followed by Routine Prophylaxis treatment for 1 year.
Moroctocog alfa (AF-CC)
On-demand therapy for 6 months, followed by routine prophylaxis 25 IU/kg, administered every other day for 1 year.
2
Routine Prophylaxis Crossover
Moroctocog alfa (AF-CC)
Routine prophylaxis crossover:
45 IU/kg, administered 2 times a week for 1 year followed by 25 IU/kg administered every other day for 1 year, or, 25 IU/kg, administered every other day for 1 year, followed by 45 IU/kg, administered 2 times a week for 1 year.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Moroctocog alfa (AF-CC)
On-demand therapy for 6 months, followed by routine prophylaxis 25 IU/kg, administered every other day for 1 year.
Moroctocog alfa (AF-CC)
Routine prophylaxis crossover:
45 IU/kg, administered 2 times a week for 1 year followed by 25 IU/kg administered every other day for 1 year, or, 25 IU/kg, administered every other day for 1 year, followed by 45 IU/kg, administered 2 times a week for 1 year.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* A negative FVIII inhibitor titer at screening, and a medical history negative for a past FVIII inhibitor.
* At least 20 exposure days to any FVIII replacement product.
* Adequate hepatic and renal function
* CD4 count \> 400 cells/uL, and if receiving antiviral therapy must be on a stable regimen
Additional criteria for subjects participating in the PK assessment:
* Male subjects as described immediately above except they must have a FVIII Activity of less than or equal to 1% confirmed by the central laboratory screening test
* Age \< 6 years at time of PK assessment.
* The subject's size is sufficient to permit PK-related phlebotomy.
* The subject is able to comply with the procedures conducted during the PK assessment, including a mandatory 72-hour washout period preceding the PK assessment.
Exclusion Criteria
* Presence of a bleeding disorder in addition to hemophilia A.
* Treatment with any investigational drug or device within 30 days before the time of signing the informed consent form.
* Major or orthopedic surgery planned to occur during the course of the study.
* Regular (e.g., daily, every other day) use of antifibrinolytic agents or medications known to influence platelet function such as aspirin or certain nonsteroidal anti-inflammatory drugs (NSAIDs), or regular, concomitant therapy with immunomodulating drugs (e.g., intravenous immunoglobulin \[IVIG\], routine systemic corticosteroids).
* Known hypersensitivity to hamster protein.
6 Months
15 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
OHSU Investigational Pharmacy
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Childrens Medical Center Dallas
Dallas, Texas, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Fundacion de la Hemofilia
Buenos Aires, , Argentina
Medizinische Universitaet Wien
Vienna, , Austria
Liga Colombiana de Hemofílicos y otras Deficiencias Sanguíneas
Bogotá, , Colombia
Clinical Hospital Centre Split
Split, , Croatia
Jordan University of Science and Technology, King Abdullah University Hospital
Irbid, , Jordan
Hospital Civil de Guadalajara Dr. Juan I. Menchaca
Guadalajara, Jalisco, Mexico
Hospital y Clinica OCA S.A. de C.V.
Colonia Centro, Monterrey, Nuevo LEON, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico
Christchurch Hospital
Christchurch, South Island, New Zealand
Canterbury District Health Board
Christchurch, , New Zealand
Sultan Qaboos University Hospital
Muscat, , Oman
Centro Medico Monte Carmelo
Urbanización La Victoria, Arequipa, Peru
Samodzielny Publiczny Dzieciecy Szpital Kliniczny
Warsaw, , Poland
Sanador
Bucharest, , Romania
Cukurova University Tip Fakultesi
Balcali/Adana, Adana, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Cocuk Hastanesi
Izmir, Bornova, Turkey (Türkiye)
Istanbul Universtesi Istanbul Tip Fakultesi
Çapa, Istanbul, Turkey (Türkiye)
On Dokuz Mayis University Faculty of Medicine
Samsun, Kurupelit, Turkey (Türkiye)
Akdeniz Universitesi Tip Fakultesi
Antalya, , Turkey (Türkiye)
Dr. Behcet Uz Child and Diseases And Surgery Education and Research Hospital
Izmir, , Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi
Kayseri, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B1831001
Identifier Type: OTHER
Identifier Source: secondary_id
2006-005575-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3082B2-313
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.