Study Evaluating Prophylaxis Treatment & Characterizing Efficacy, Safety, & PK Of B-Domain Deleted Recombinant FVIII

PHASE3CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

April 30, 2018

Study Completion Date

April 30, 2018

Conditions
Hemophilia A
Interventions
BIOLOGICAL

Moroctocog alfa (AF-CC)

On-demand therapy for 6 months, followed by routine prophylaxis 25 IU/kg, administered every other day for 1 year.

BIOLOGICAL

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."

Trial Locations (28)

123

Sultan Qaboos University Hospital, Muscat

1090

Medizinische Universitaet Wien, Vienna

8001

Christchurch Hospital, Christchurch

Canterbury District Health Board, Christchurch

21000

Clinical Hospital Centre Split, Split

22110

Jordan University of Science and Technology, King Abdullah University Hospital, Irbid

34390

Istanbul Universtesi Istanbul Tip Fakultesi, Çapa

35100

Ege Universitesi Tip Fakultesi Cocuk Hastanesi, Izmir

35210

Dr. Behcet Uz Child and Diseases And Surgery Education and Research Hospital, Izmir

38039

Erciyes Universitesi Tip Fakultesi, Kayseri

44340

Hospital Civil de Guadalajara Dr. Juan I. Menchaca, Guadalajara

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

55139

On Dokuz Mayis University Faculty of Medicine, Samsun

64000

Hospital y Clinica OCA S.A. de C.V., Colonia Centro

64460

"Hospital Universitario Dr. Jose Eleuterio Gonzalez", Monterrey

75235

Childrens Medical Center Dallas, Dallas

84108

University of Utah, Salt Lake City

84113

Primary Children's Hospital, Salt Lake City

97239

OHSU Investigational Pharmacy, Portland

Oregon Health & Science University, Portland

75390-9063

University of Texas Southwestern Medical Center at Dallas, Dallas

C1425BWE

Fundacion de la Hemofilia, Buenos Aires

Unknown

Liga Colombiana de Hemofílicos y otras Deficiencias Sanguíneas, Bogotá

054

Centro Medico Monte Carmelo, Urbanización La Victoria

00-576

Samodzielny Publiczny Dzieciecy Szpital Kliniczny, Warsaw

011026

Sanador, Bucharest

01330

Cukurova University Tip Fakultesi, Balcali/Adana

07059

Akdeniz Universitesi Tip Fakultesi, Antalya

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT00543439 - Study Evaluating Prophylaxis Treatment & Characterizing Efficacy, Safety, & PK Of B-Domain Deleted Recombinant FVIII | Biotech Hunter | Biotech Hunter