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

Primary Purpose

Hemophilia A

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Moroctocog alfa (AF-CC)

About this trial

This is an interventional treatment trial for Hemophilia A

Eligibility Criteria

6 Months - 15 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Male subjects, aged less than 6 years, with moderately severe to severe hemophilia A.
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:

A history of FVIII inhibitor.
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.

Sites / Locations

Cincinnati Children's Hospital Medical Center
OHSU Investigational Pharmacy
Oregon Health & Science University
Childrens Medical Center Dallas
University of Texas Southwestern Medical Center at Dallas
University of Utah
Primary Children's Hospital
Fundacion de la Hemofilia
Medizinische Universitaet Wien
Liga Colombiana de Hemofílicos y otras Deficiencias Sanguíneas
Clinical Hospital Centre Split
Jordan University of Science and Technology, King Abdullah University Hospital
Hospital Civil de Guadalajara Dr. Juan I. Menchaca
Hospital y Clinica OCA S.A. de C.V.
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Christchurch Hospital
Canterbury District Health Board
Sultan Qaboos University Hospital
Centro Medico Monte Carmelo
Samodzielny Publiczny Dzieciecy Szpital Kliniczny
Sanador
Cukurova University Tip Fakultesi
Ege Universitesi Tip Fakultesi Cocuk Hastanesi
Istanbul Universtesi Istanbul Tip Fakultesi
On Dokuz Mayis University Faculty of Medicine
Akdeniz Universitesi Tip Fakultesi
Dr. Behcet Uz Child and Diseases And Surgery Education and Research Hospital
Erciyes Universitesi Tip Fakultesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

On-Demand therapy for 6 months, followed by Routine Prophylaxis treatment for 1 year.

Routine Prophylaxis Crossover

Outcomes

Primary Outcome Measures

Mean Annualized Bleed Rate (ABR) by Treatment: On Demand Cohort

ABR for each participant was calculated as the number of bleeds requiring administration of moroctocog alfa (AF-CC) divided by the total therapy duration (in days), then multiplied by 365.25 (days in a year).

Secondary Outcome Measures

Mean Annualized Bleed Rate (ABR) by Treatment: Routine Prophylaxis Cohort

Mean of Moroctocog Alfa (AF-CC) Infusions Administered To Treat Bleeding Episode: All Participants

In this outcome measure, the mean of total number of moroctocog alfa (AF-CC) on-demand infusions administered to treat each bleeding episode was reported, regardless of participant cohort or period during which it occurred.

Number of Treated Bleeds Classified on Basis of Response to First Infusion of Moroctocog Alfa (AF-CC) as On-Demand Treatment: OD Therapy (OD and RP Cohort)

Number (no.) of bleeds treated are reported on basis of response to first infusion of study drug, at 4-point scale: excellent, good, moderate, no response. Excellent:definite pain relief and/or improvement in bleeding signs within 8 hours (hr) after infusion, no additional infusion administered; Good:definite pain relief and/or improvement in bleeding signs within 8 hr after infusion, at least 1 additional infusion administered for complete resolution or with no additional infusion administered; Moderate:probable or slight improvement starting after 8 hr following infusion,at least 1 additional infusion administered for complete resolution; No Response: no improvement at all between infusions or during 24 hr interval following infusion or condition worsen. Bleeds for which response not recorded, reported as:Data Not Recorded. Total no. of first infusions may not be equal to total no. of bleeds if bleed was: missing start date/dose information or treated initially with non-study FVIII.

Number of Treated Spontaneous Bleeds by Time Interval Between Bleed Onset and Prior Moroctocog Alfa (AF-CC) Prophylaxis Dose: Routine Prophylaxis Therapy

In this outcome measure number of treated spontaneous bleeds are reported according to the time interval between bleed onset and prior moroctocog alfa (AF-CC) routine prophylaxis dose. Following time intervals used to report this outcome measure: lesser than or equal to (<=) 24 hours, greater than (>) 24 hours to <=48 hours, >48 hours to <=72 hours, >72 hours. For reporting arm: "Moroctocog alfa (AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg" cumulative data for routine prophylaxis cohort (Day 1 up to Month 24, Period 1 and Period 2) and on demand cohort (Month 7 up to Month 18, Period 2) is reported.

Number of Participants Requiring Prophylaxis Regimen Escalation: Routine Prophylaxis Therapy

During prophylaxis, criteria for prophylaxis regimen escalation are the occurrence, over a 4-week duration (and in the absence of a confirmed FVIII inhibitor), of (a) 2 or more spontaneous bleeds into a major joint and/or target joint, or (b) 3 or more spontaneous bleeds (consisting of joint bleeds and/or significant soft tissue/muscle or other site bleeds). If either criterion was met, the participant was escalated to a more intense prophylaxis regimen of 45 IU/kg, administered every other day. Participant who meet dose escalation criteria while on prophylaxis regimen of 45 IU/kg, were escalated to a higher intensity regimen designated by the investigator. Significant spontaneous bleeds were those that led to a transient or persistent loss of function. For reporting arm: "Moroctocog alfa (AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg", cumulative data for RP cohort (Day 1 up to Month 24, Period 1 and Period 2) and OD cohort (Month 7 up to Month 18, Period 2) is reported.

Mean Routine Prophylaxis Dose (IU/kg) of Moroctocog Alfa (AF-CC) Received: Routine Prophylaxis Therapy

Mean RP dose (by weight) for each participant was calculated as his total moroctocog alfa (AF-CC) consumption (in IU) divided by weight (in kg). For reporting arm: "Moroctocog alfa (AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg", cumulative data for routine prophylaxis cohort (Day 1 up to Month 24, Period 1 and Period 2) and on demand cohort (Month 7 up to Month 18, Period 2) is reported.

Mean of Total Number Moroctocog Alfa (AF-CC) Infusions Received: Routine Prophylaxis Therapy

In this outcome measure mean of total number of infusions of moroctocog alfa (AF-CC) received by participant is reported. For reporting arm: "Moroctocog alfa (AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg", cumulative data for routine prophylaxis cohort (Day 1 up to Month 24, Period 1 and Period 2) and on demand cohort (Month 7 up to Month 18, Period 2) is reported.

Mean of Total Number of Days Participants Exposed to Moroctocog Alfa (AF-CC): Routine Prophylaxis Therapy

For reporting arm: "Moroctocog alfa (AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg", cumulative data for routine prophylaxis cohort (Day 1 up to Month 24, Period 1 and Period 2) and on demand cohort (Month 7 up to Month 18, Period 2) is reported.

Mean of Total Number of Infusions of Moroctocog Alfa (AF-CC) Received Per Week to Assess Compliance: Routine Prophylaxis Therapy

Participants' compliance to their assigned prophylaxis regimen was measured by following: a) number of infusions received per week and b) dose received. In this outcome measure mean of total number of infusions of moroctocog alfa (AF-CC) received by participants per week is reported. For reporting arm: "Moroctocog alfa (AF-CC),OD and RP Cohort: RP Therapy 25 IU/kg" cumulative data for routine prophylaxis cohort (Day 1 up to Month 24, Period 1 and Period 2) and on demand cohort (Month 7 up to Month 18, Period 2) is reported.

Terminal Phase Half Life (t1/2) of Factor VIII (FVIII) Activity

Plasma decay half-life is the time measured for the FVIII activity to decrease by one half.

Clearance (CL) of Factor VIII Activity

Clearance is a measure of the volume of plasma from which FVIII activity is removed per unit time. It was reported in units milliliter per hour per kilogram (mL/hr/kg).

Incremental Recovery of Factor VIII Activity

Incremental recovery was the increase in circulating FVIII activity for every international unit (IU) of moroctocog alfa (AF-CC) administered per kilogram of body weight of participant. It was measured in international units per deciliter per international units per kilogram ([IU/dL]/[IU/kg]).

Maximum Concentration of Factor VIII Activity

Maximum concentration of FVIII activity was measured in international units per milliliter (IU/mL).

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Factor VIII Activity

Area under FVIII activity-time profile from time zero extrapolated to infinite time. AUCinf is reported in units: international units*hour per milliliter (IU*hour/mL).

Area Under the Curve From Time Zero to Last Measurable Concentration (AUClast) of Factor VIII Activity

Area under the FVIII activity -versus-time curve from time zero to the time of the last quantifiable concentration.

Steady-State Volume of Distribution (Vss) of Factor VIII Activity

Volume of distribution is defined as the theoretical volume in which the total amount of FVIII would need to be uniformly distributed to produce the observed plasma concentration of FVIII. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.

Mean Residence Time (MRT) of Factor VIII Activity

MRT was calculated as AUMCinf /AUCinf-TI/2, where AUMCinf is the area under the moment curve from time zero to infinity and TI is the duration of infusion.

Number of Participants With Treatment Emergent Adverse Events (AEs) According to Severity

AE is untoward medical occurrence in clinical investigation participant administered product or medical device;event need not necessarily had causal relationship with treatment or usage.Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug (up to 25 months)that were absent before treatment or that worsened relative to pretreatment state.AEs were classified into following on basis of severity:1)mild = did not interfere with participant's usual function;2)moderate=interfered to some extent with participant's usual function;3)severe=interfered significantly with participant's usual function;4)life threatening=AE required discontinuation of study drug,participant was at immediate risk of death.All participants in study received AF-CC.AEs were not collected separately for each intervention for participants.All participants were properly combined for analysis,regardless of regimen were following at time,regardless of OD or RP cohort.

Number of Participants With Treatment-Related Adverse Events

A treatment related AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event had a causal relationship with the treatment or usage. All participants in the study received moroctocog alfa-(AF-CC). Adverse events were not collected separately for each intervention for the participants. All participants were properly combined for the analysis and was regardless of the regimen they were following at the time, and regardless of OD or RP cohort.

Number of Participants With Confirmed FVIII Inhibitor Development

Confirmed FVIII inhibitors were defined as a neutralizing antibody to FVIII with a titer value of greater than or equal to (>=) 0.6 Bethesda units (BU) per millimeter in a sample assayed using the Nijmegen assay at the central laboratory.

Number of Participants With Incidence of Less Than Expected Therapeutic Effect (LETE): On Demand Therapy

LETE occurs in OD setting if participant recorded 2 successive "No Response" (no improvement at all between infusions, or condition worsens) ratings after 2 successive infusions of study drug. Infusions must have been given within 24 hours (hr) of each other for treatment of same bleeding event in absence of confounding factors (known presence or subsequent identification of a FVIII inhibitor, known inadequate dose for type and/or severity of bleed in opinion of investigator, delay of >4 hr between onset of bleed to infusion, delay of >24 hr before administration of a follow-up infusion, known compromised study drug, faulty administration of study drug, participant had an underlying, predisposing condition responsible for bleed in opinion of investigator. For reporting arm: "Moroctocog alfa (AF-CC), OD and RP Cohort: RP Therapy 25 IU/kg", cumulative data for RP cohort (Day 1 up to Month 24, Period 1 and Period 2) and OD cohort (Month 7 up to Month 18, Period 2) is reported.

Number of Participants With Incidence of Less Than Expected Therapeutic Effect (LETE): Routine Prophylaxis Therapy

LETE in prophylaxis setting if there was a spontaneous bleed within 48 hours after a regularly scheduled prophylactic dose of study drug (which was not used to treat a bleed) in the absence of confounding factors (known presence or subsequent identification of a FVIII inhibitor, known inadequate prophylactic dose [a dose less than that prescribed in participant's regimen], known lack of adherence to the prescribed prophylaxis regimen, bleed occurs in a target joint identified at the start of the study, known compromised study drug, faulty administration of study drug, participant had an underlying, predisposing condition responsible for the bleed in the opinion of the investigator. Therefore, LETE in the prophylaxis setting was the occurrence of a bleed. For reporting arm: "Moroctocog alfa (AF-CC), OD and RP Cohort: RP Therapy 25 IU/kg", cumulative data for RP cohort (Day 1 up to Month 24, Period 1 and Period 2) and OD cohort (Month 7 up to Month 18, Period 2) is reported.

Full Information

NCT ID

NCT00543439

First Posted

October 11, 2007

Last Updated

December 14, 2018

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00543439

Brief Title

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

Official Title

An Open-label Study To Evaluate Prophylaxis Treatment, And To Characterize The Efficacy, Safety, And Pharmacokinetics Of B-domain Deleted Recombinant Factor Viii Albumin Free (Moroctocog Alfa [Af-cc]) In Children With Hemophilia A

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

December 2007 (Actual)

Primary Completion Date

April 2018 (Actual)

Study Completion Date

April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this research study is to determine the effectiveness, safety, and pharmacokinetics (PK) of moroctocog alfa (AF-CC) in previously treated subjects, who are younger than 6 years of age, with severe or moderately severe hemophilia A.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemophilia A

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

On-Demand therapy for 6 months, followed by Routine Prophylaxis treatment for 1 year.

Arm Title

Arm Type

Experimental

Arm Description

Routine Prophylaxis Crossover

Intervention Type

Biological

Intervention Name(s)

Moroctocog alfa (AF-CC)

Other Intervention Name(s)

Xyntha

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Moroctocog alfa (AF-CC)

Other Intervention Name(s)

Xyntha

Intervention Description

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.

Primary Outcome Measure Information:

Title

Mean Annualized Bleed Rate (ABR) by Treatment: On Demand Cohort

Description

Time Frame

Day 1 up to Month 6 (OD Cohort, OD Therapy, Period 1); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)

Secondary Outcome Measure Information:

Title

Mean Annualized Bleed Rate (ABR) by Treatment: Routine Prophylaxis Cohort

Description

Time Frame

Day 1 up to Month 24 (RP Cohort, Period 1 and Period 2)

Title

Mean of Moroctocog Alfa (AF-CC) Infusions Administered To Treat Bleeding Episode: All Participants

Description

Time Frame

Day 1 up to Month 24

Title

Number of Treated Bleeds Classified on Basis of Response to First Infusion of Moroctocog Alfa (AF-CC) as On-Demand Treatment: OD Therapy (OD and RP Cohort)

Description

Time Frame

Day 1 up to Month 24

Title

Number of Treated Spontaneous Bleeds by Time Interval Between Bleed Onset and Prior Moroctocog Alfa (AF-CC) Prophylaxis Dose: Routine Prophylaxis Therapy

Description

Time Frame

Day 1 up to Month 24 (RP Cohort, RP 25 IU/kg and 45 IU/kg, Period 1 and 2); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)

Title

Number of Participants Requiring Prophylaxis Regimen Escalation: Routine Prophylaxis Therapy

Description

Time Frame

Day 1 up to Month 24 (RP Cohort, RP 25 IU/kg and 45 IU/kg, Period 1 and 2); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)

Title

Mean Routine Prophylaxis Dose (IU/kg) of Moroctocog Alfa (AF-CC) Received: Routine Prophylaxis Therapy

Description

Time Frame

Day 1 up to Month 24 (RP Cohort, RP 25 IU/kg and 45 IU/kg, Period 1 and 2); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)

Title

Mean of Total Number Moroctocog Alfa (AF-CC) Infusions Received: Routine Prophylaxis Therapy

Description

Time Frame

Day 1 up to Month 24 (RP Cohort, RP 25 IU/kg and 45 IU/kg, Period 1 and 2); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)

Title

Mean of Total Number of Days Participants Exposed to Moroctocog Alfa (AF-CC): Routine Prophylaxis Therapy

Description

Time Frame

Day 1 up to Month 24 (RP Cohort, RP 25 IU/kg and 45 IU/kg, Period 1 and 2); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)

Title

Mean of Total Number of Infusions of Moroctocog Alfa (AF-CC) Received Per Week to Assess Compliance: Routine Prophylaxis Therapy

Description

Time Frame

Day 1 up to Month 24 (RP Cohort, RP 25 IU/kg and 45 IU/kg, Period 1 and 2); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)

Title

Terminal Phase Half Life (t1/2) of Factor VIII (FVIII) Activity

Description

Plasma decay half-life is the time measured for the FVIII activity to decrease by one half.

Time Frame

0.5, 8, 24, 28 and 32 hours post dose on Day 1

Title

Clearance (CL) of Factor VIII Activity

Description

Clearance is a measure of the volume of plasma from which FVIII activity is removed per unit time. It was reported in units milliliter per hour per kilogram (mL/hr/kg).

Time Frame

0.5, 8, 24, 28 and 32 hours post dose on Day 1

Title

Incremental Recovery of Factor VIII Activity

Description

Time Frame

Day 1, Month 6

Title

Maximum Concentration of Factor VIII Activity

Description

Maximum concentration of FVIII activity was measured in international units per milliliter (IU/mL).

Time Frame

0.5, 8, 24, 28 and 32 hours post dose on Day 1

Title

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Factor VIII Activity

Description

Area under FVIII activity-time profile from time zero extrapolated to infinite time. AUCinf is reported in units: international units*hour per milliliter (IU*hour/mL).

Time Frame

0.5, 8, 24, 28 and 32 hours post dose on Day 1

Title

Area Under the Curve From Time Zero to Last Measurable Concentration (AUClast) of Factor VIII Activity

Description

Area under the FVIII activity -versus-time curve from time zero to the time of the last quantifiable concentration.

Time Frame

0.5, 8, 24, 28 and 32 hours post dose on Day 1

Title

Steady-State Volume of Distribution (Vss) of Factor VIII Activity

Description

Time Frame

0.5, 8, 24, 28 and 32 hours post dose on Day 1

Title

Mean Residence Time (MRT) of Factor VIII Activity

Description

MRT was calculated as AUMCinf /AUCinf-TI/2, where AUMCinf is the area under the moment curve from time zero to infinity and TI is the duration of infusion.

Time Frame

0.5, 8, 24, 28 and 32 hours post dose on Day 1

Title

Number of Participants With Treatment Emergent Adverse Events (AEs) According to Severity

Description

Time Frame

Day 1 up to Month 25

Title

Number of Participants With Treatment-Related Adverse Events

Description

Time Frame

Day 1 up to Month 25

Title

Number of Participants With Confirmed FVIII Inhibitor Development

Description

Time Frame

Day 1 up to Month 24

Title

Number of Participants With Incidence of Less Than Expected Therapeutic Effect (LETE): On Demand Therapy

Description

Time Frame

Day 1 up to Month 24 (RP Cohort, RP 25 IU/kg and 45 IU/kg, Period 1 and 2); Day 1 up to Month 6 (OD Cohort, OD Therapy, Period 1); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)

Title

Number of Participants With Incidence of Less Than Expected Therapeutic Effect (LETE): Routine Prophylaxis Therapy

Description

Time Frame

Day 1 up to Month 24 (RP Cohort, RP 25 IU/kg and 45 IU/kg, Period 1 and 2); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)

10. Eligibility

Sex

Male

Gender Based

Yes

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male subjects, aged less than 6 years, with moderately severe to severe hemophilia A. 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: A history of FVIII inhibitor. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Cincinnati Children's Hospital Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Facility Name

OHSU Investigational Pharmacy

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Oregon Health & Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Childrens Medical Center Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

University of Texas Southwestern Medical Center at Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-9063

Country

United States

Facility Name

University of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84108

Country

United States

Facility Name

Primary Children's Hospital

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84113

Country

United States

Facility Name

Fundacion de la Hemofilia

City

Buenos Aires

ZIP/Postal Code

C1425BWE

Country

Argentina

Facility Name

Medizinische Universitaet Wien

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Liga Colombiana de Hemofílicos y otras Deficiencias Sanguíneas

City

Bogota

Country

Colombia

Facility Name

Clinical Hospital Centre Split

City

Split

ZIP/Postal Code

21000

Country

Croatia

Facility Name

Jordan University of Science and Technology, King Abdullah University Hospital

City

Irbid

ZIP/Postal Code

22110

Country

Jordan

Facility Name

Hospital Civil de Guadalajara Dr. Juan I. Menchaca

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44340

Country

Mexico

Facility Name

Hospital y Clinica OCA S.A. de C.V.

City

Colonia Centro

State/Province

Monterrey, Nuevo LEON

ZIP/Postal Code

64000

Country

Mexico

Facility Name

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

City

Monterrey

State/Province

Nuevo LEON

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Christchurch Hospital

City

Christchurch

State/Province

South Island

ZIP/Postal Code

8001

Country

New Zealand

Facility Name

Canterbury District Health Board

City

Christchurch

ZIP/Postal Code

8001

Country

New Zealand

Facility Name

Sultan Qaboos University Hospital

City

Muscat

ZIP/Postal Code

123

Country

Oman

Facility Name

Centro Medico Monte Carmelo

City

Urbanización La Victoria

State/Province

Arequipa

ZIP/Postal Code

054

Country

Peru

Facility Name

Samodzielny Publiczny Dzieciecy Szpital Kliniczny

City

Warszawa

ZIP/Postal Code

00-576

Country

Poland

Facility Name

Sanador

City

Bucuresti

ZIP/Postal Code

011026

Country

Romania

Facility Name

Cukurova University Tip Fakultesi

City

Balcali/Adana

State/Province

Adana

ZIP/Postal Code

01330

Country

Turkey

Facility Name

Ege Universitesi Tip Fakultesi Cocuk Hastanesi

City

Izmir

State/Province

Bornova

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Istanbul Universtesi Istanbul Tip Fakultesi

City

Capa

State/Province

Istanbul

ZIP/Postal Code

34390

Country

Turkey

Facility Name

On Dokuz Mayis University Faculty of Medicine

City

Samsun

State/Province

Kurupelit

ZIP/Postal Code

55139

Country

Turkey

Facility Name

Akdeniz Universitesi Tip Fakultesi

City

Antalya

ZIP/Postal Code

07059

Country

Turkey

Facility Name

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

City

Izmir

ZIP/Postal Code

35210

Country

Turkey

Facility Name

Erciyes Universitesi Tip Fakultesi

City

Kayseri

ZIP/Postal Code

38039

Country

Turkey

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3082B2-313&StudyName=Study%20Evaluating%20Prophylaxis%20Treatment%20%26%20Characterizing%20Efficacy%2C%20Safety%2C%20%26%20PK%20Of%20B-Domain%20Deleted%20Recombinant%20FVIII

Description

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

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