Study Evaluating Safety And Efficacy Of Moroctocog Alfa (AF-CC) In Previously Treated Hemophilia A Patients

NCT ID: NCT00914459

Last Updated: 2017-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2016-04-30

Brief Summary

The study will be investigating pharmacokinetics, safety and efficacy in patients less than 12 years of age with severe hemophilia A that have been previously treated with Factor VIII products ( including blood products).

Conditions

Hemophilia A

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Moroctocog alfa (AF-CC)

Open Label

Group Type: OTHER

Moroctocog alfa ( AF-CC)

Intervention Type: BIOLOGICAL

Dosing is at the discretion of the Investigator

Laboratory tests

Intervention Type: PROCEDURE

Factor VIII PK samples, Hematology, Chemistry and Coagulation testing, FactorVIII Inhibitor and Anti Factor VIII antibody

Interventions

Moroctocog alfa ( AF-CC)

Dosing is at the discretion of the Investigator

Intervention Type: BIOLOGICAL

Laboratory tests

Factor VIII PK samples, Hematology, Chemistry and Coagulation testing, FactorVIII Inhibitor and Anti Factor VIII antibody

Intervention Type: PROCEDURE

Other Intervention Names

ReFacto AF

Eligibility Criteria

Inclusion Criteria

• Male subjects less than 12 years of age with a documented history of severe hemophilia A (FVIII:C less than 1%).
• Subjects who are less than 6 years of age must have had at least 50 Exposure Days (EDs) to prior FVIII products (including blood products).
• Subjects who are equal to or greater than 6 years of age must have had greater than 150 EDs to prior FVIII products (including blood products).

Exclusion Criteria

• For laboratory assessments, any measured Bethesda inhibitor titer equal to or greater than 0.6 BU, regardless of the laboratory normal range, or any Bethesda inhibitor titer greater than ULN for the testing laboratory at the time of screening.
• Any other bleeding disorder in addition to hemophilia A.
• Treatment with any investigational drug or device within 30 days before the time of signing the parental informed consent/assent form.
• Major surgery planned to occur during the course of the study.
• Regular (e.g., daily; every other day) use of agents or medications known to influence platelet function such as aspirin or certain nonsteroidal anti-inflammatory drugs (NSAIDS).
• Regular, concomitant therapy with immunomodulating drugs (e.g., intravenous immunoglobulin [IVIG], routine systemic corticosteroids), or currently receiving immune tolerance induction (ITI) for inhibitor treatment.
• The subject is receiving treatment for HIV or hepatitis infection (unless the subject is on a stable antiviral regimen [i.e., consistent treatment regimen for at least 3 months before the parental informed consent/assent form is signed]).
• Platelet count less than 100,000/µL.
• Prothrombin time (PT) equal to or greater than 1.25 x ULN, or international normalized ratio (INR) equal to or greater than 1.5.
• Known hypersensitivity to hamster protein.

• Maximum Eligible Age: 11 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Kuopio University Hospital

Kuopio, , Finland

LTD Medinvesti- Institute of hematology and transfusiology

Tbilisi, , Georgia

Centro di Riferimento Regionale per la cura dell'Emofilia e delle Malattie Emorragiche Congenite

Parma, , Italy

Spitalul Clinic Judetean de Urgenta Craiova

Craiova, Dolj, Romania

Sanador

Bucharest, , Romania

University Children's Hospital

Belgrade, , Serbia

Mother and Child Health Care Institute of Serbia "Dr Vukan Cupic"

Belgrade, , Serbia

Hospital Jerez de la Frontera

Jerez de la Frontera, Cádiz, Spain

Hospital Universitario Puerta del Mar

Cadiz, Spain, Spain

Hospital Universitario Miguel Servet

Zaragoza, Zaragoza, Spain

Hospital La Paz

Madrid, , Spain

Karolinska Universitetssjukhuset-Solna

Stockholm, , Sweden

Cukurova University Department of Pediatrics, Pediatric Hematology Division

Adana, Balcali/adana, Turkey (Türkiye)

Ege University Department of Pediatrics, Pediatric Hematology Division

Izmir, Bornova /izmir, Turkey (Türkiye)

Akdeniz Universitesi Tip Fakultesi

Antalya, Kampus, Turkey (Türkiye)

Komunalna ustanova "Zaporizka oblasna klinichna dytiacha likarnia"

Zaporizhzhia, Ukraine, Ukraine

Derzhavna ustanova "Instytut patolohii krovi ta transfuziinoi medytsyny Natsionalnoi akademii medych

Lviv, , Ukraine

Countries

Finland; Georgia; Italy; Romania; Serbia; Spain; Sweden; Turkey (Türkiye); Ukraine

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3082B2-4433&StudyName=Study%20Evaluating%20Safety%20And%20Efficacy%20Of%20Moroctocog%20Alfa%20%28AF-CC%29%20In%20Previously%20Treated%20Hemophilia%20A%20Patients

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

Other Identifiers

B1831005

Identifier Type: OTHER

Identifier Source: secondary_id

2008-008435-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3082B2-4433

Identifier Type: -

Identifier Source: org_study_id