Back to resultsStudy Evaluating Safety And Efficacy Of Moroctocog Alfa (AF-CC) In Previously Treated Hemophilia A Patients
Primary Purpose
Hemophilia A
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Moroctocog alfa ( AF-CC)
Laboratory tests
Sponsored by
About this trial
This is an interventional treatment trial for Hemophilia A focused on measuring hemophilia A
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.
Sites / Locations
- Kuopio University Hospital
- LTD Medinvesti- Institute of hematology and transfusiology
- Centro di Riferimento Regionale per la cura dell'Emofilia e delle Malattie Emorragiche Congenite
- Spitalul Clinic Judetean de Urgenta Craiova
- Sanador
- University Children's Hospital
- Mother and Child Health Care Institute of Serbia "Dr Vukan Cupic"
- Hospital Jerez de la Frontera
- Hospital Universitario Puerta del Mar
- Hospital La Paz
- Hospital Universitario Miguel Servet
- Karolinska Universitetssjukhuset-Solna
- Cukurova University Department of Pediatrics, Pediatric Hematology Division
- Ege University Department of Pediatrics, Pediatric Hematology Division
- Akdeniz Universitesi Tip Fakultesi
- Derzhavna ustanova "Instytut patolohii krovi ta transfuziinoi medytsyny Natsionalnoi akademii medych
- Komunalna ustanova "Zaporizka oblasna klinichna dytiacha likarnia"
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Moroctocog alfa (AF-CC)
Arm Description
Open Label
Outcomes
Primary Outcome Measures
Percentage of Participants With Clinically Significant Factor VIII Inhibitor Development
Clinically significant factor VIII (FVIII) inhibitors were defined as a central laboratory confirmed positive inhibitor of greater than or equal to (>=) 0.6 Bethesda units (BU) using the Nijmegen modification of the Bethesda assay present at 2 consecutive blood draws within a 6-week interval and one of the following within 4 weeks before the initial or within 4 weeks following the second positive FVIII inhibitor sample collection: 1) the need for the participant to administer alternative hemostatic products in order to achieve sufficient efficacy, 2) >=2 events indicating a decrease in the efficacy of the study treatment. Percentage of participants who developed clinically significant Factor VIII inhibitor after study drug administration were reported.
Incremental Recovery
Incremental recovery was the increase in circulating FVIII activity for every international unit (IU) of ReFacto AF administered per kilogram of body weight. It was measured in international units per deciliter (IU/dL) per international units per kilogram (IU/kg).
Terminal Elimination Half Life of ReFacto AF (t1/2)
T1/2 was the time for the plasma concentration of drug to decrease by one-half of its original concentration.
Clearance (CL)
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Secondary Outcome Measures
Mean Annualized Bleeding Rates (ABRs): All Participants
ABR for each participant was calculated as the number of bleeds requiring administration of FVIII replacement product (taken from the Infusion Log Diary case report form), divided by the total therapy duration (in days), then multiplied by 365.25. ABR for the participants who reported following a primary or secondary prophylaxis, on-demand regimen or preventive regimen at baseline were reported.
Response to First On-Demand Treatment for New Bleeds: All Participants
A 4-point scale of assessment of 'on-demand' treatment (administration of an unscheduled bolus infusion of Refacto-AF to stop bleeding) is defined as: 1. Excellent: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with no additional infusion administered. 2. Good: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with at least one additional infusion administered for complete resolution of the bleeding episode;or, Definite pain relief and/or improvement in signs of bleeding starting after 8 hours following infusion, with no additional infusion administered. 3. Moderate: Probable or slight improvement starting after 8 hours following the infusion, with at least one additional infusion administered for complete resolution of the bleeding episode. 4. No Response: No improvement at all between infusions or during the 24-hour interval following an infusion, or condition worsens.
Number of On-Demand ReFacto AF Infusions to Treat a New Bleed: All Participants
The infusion log diary case report form (CRF) was used to determine the number of on-demand (administration of an unscheduled bolus infusion of Refacto-AF to stop bleeding) ReFacto AF infusions administered to treat a new bleed. This was calculated by adding the initial for a new bleed (on-demand) infusion to any subsequent (on-demand) infusions for the same "previously treated bleed" (same bleed with same start date/time).
Number of Breakthrough Bleeds Within 48 Hours of a Prophylaxis Dose of ReFacto AF: All Participants
The number of breakthrough bleeds within 48 hours following a prophylaxis dose of ReFacto AF was summarized. The infusion log diary CRF was used to determine the number of infusions administered to treat a new bleed counting only those infusions which were administered <=48 hours after an infusion marked as "prophylaxis" (which had no associated bleed).
Average Infusion Dose of ReFacto AF: All Participants
The average infusion dose (by weight) for each participant was calculated as his total factor FVIII consumption (in IU) divided by weight (in kg) divided by the number of infusions administered in total study duration. Data was reported separately for participants classified at baseline as following non-prophylaxis regimen (for example: on-demand regimen, preventive, or not specified), and participants classified at baseline following a primary or secondary prophylaxis regimen.
Total Factor VIII Consumption: All Participants
Total factor VIII consumption for each participant was calculated by sum of the total amount of ReFacto AF (in IU) infused for each ReFacto AF infusion (recorded in the infusion log diary CRF). Data was reported separately for participants classified at baseline as following non-prophylaxis regimen (for example: on-demand regimen, preventive, or not specified), and participants classified at baseline following a primary or secondary prophylaxis regimen.
Number of Less-Than-Expected-Therapeutic Effect (LETE) Bleeds in the On-Demand Setting: All Participants
LETE in on-demand setting was based on response to treatment of a bleeding episode. LETE in the on-demand setting occurred if participant recorded 2 successive "no response" ratings after 2 successive ReFacto AF infusions. Both infusions were to be administered at an interval of 24 hours for treatment of same bleeding event in absence of confounding factor which included: 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 greater than 4 hours between onset of bleed to infusion, delay of greater than 24 hours before administration of a follow-up infusion, known compromised ReFacto AF, faulty administration of ReFacto AF, participant had an underlying, predisposing condition responsible for bleed in opinion of investigator (e.g., kidney stones or use of medications known to impair platelet function, such as aspirin or NSAIDs),or ongoing trauma responsible for continued bleeding.
Number of Less-Than-Expected-Therapeutic Effect (LETE) Bleeds in the Prophylaxis Setting: All Participants
LETE in the prophylaxis setting occurred if there was a spontaneous bleed within 48 hours (<=48 hours) after a regularly scheduled prophylactic dose of ReFacto AF (which was not used to treat a bleed) in the absence of confounding factors. Therefore, LETE in the prophylaxis setting is the occurrence of a bleed. Confounding factors include: Known presence or subsequent identification of a FVIII inhibitor, known inadequate prophylactic dose, known lack of adherence to the prescribed prophylaxis regimen, bleed occurs in a target joint identified at the start of the study, known compromised ReFacto AF, faulty administration of ReFacto AF, an underlying, predisposing condition responsible for the bleed in the opinion of the investigator (e.g., kidney stones or use of medications known to impair platelet function, such as aspirin or NSAIDs) or traumatic injury responsible for bleeding.
Number of Occurrences of Less-Than-Expected-Therapeutic Effect (LETE) in the Low Recovery Setting: All Participants
LETE in the low recovery setting was defined as lower than expected recovery of FVIII (in the opinion of investigator), following the infusion of ReFacto AF in the absence of confounding factors for the low recovery. The only confounding factors for low recovery are as follows: known presence or subsequent identification of a FVIII inhibitor, known compromised ReFacto AF, faulty administration of ReFacto AF, including inadequate dosing.
Number of Participants Requiring Escalated Dose of Prescribed Regimen During the Treatment Period: All Participants
Participants who met the dose escalation criteria were prescribed a higher dose and/or more frequent doses as per the investigator's discretion.
Plasma Concentration of Factor VIII at 0.5 Hour Post-dose (C0.5)
Area Under the Plasma Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf)
AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time. It was calculated as International units*hour per milliliter (IU*hr/mL).
Area Under the Plasma Time Curve From Time Zero to Time of Last Measurable Concentration (AUClast)
AUClast is the area under the plasma versus time curve from time zero to time of last measurable concentration (AUClast)
Volume of Distribution at Steady State (Vss)
Volume of distribution was defined as the theoretical volume in which the total amount of drug was uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) was the apparent volume of distribution at steady-state.
Mean Residence Time (MRT) of ReFacto AF
MRT was calculated as AUMCinf / AUCinf-TI/2, where AUMCinf is the area under the first moment curve from time zero to infinity and TI was the duration of infusion.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): All Participants
An adverse event (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00914459
Brief Title
Study Evaluating Safety And Efficacy Of Moroctocog Alfa (AF-CC) In Previously Treated Hemophilia A Patients
Official Title
A Non-randomized, Open-label Study To Evaluate The Pharmacokinetics, Safety And Efficacy Of Refacto Af In Previously Treated Pediatric Subjects Less Than Twelve Years Of Age With Severe Hemophilia A (Fviii:c <1%).
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia A
Keywords
hemophilia A
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moroctocog alfa (AF-CC)
Arm Type
Other
Arm Description
Open Label
Intervention Type
Biological
Intervention Name(s)
Moroctocog alfa ( AF-CC)
Other Intervention Name(s)
ReFacto AF
Intervention Description
Dosing is at the discretion of the Investigator
Intervention Type
Procedure
Intervention Name(s)
Laboratory tests
Intervention Description
Factor VIII PK samples, Hematology, Chemistry and Coagulation testing, FactorVIII Inhibitor and Anti Factor VIII antibody
Primary Outcome Measure Information:
Title
Percentage of Participants With Clinically Significant Factor VIII Inhibitor Development
Description
Clinically significant factor VIII (FVIII) inhibitors were defined as a central laboratory confirmed positive inhibitor of greater than or equal to (>=) 0.6 Bethesda units (BU) using the Nijmegen modification of the Bethesda assay present at 2 consecutive blood draws within a 6-week interval and one of the following within 4 weeks before the initial or within 4 weeks following the second positive FVIII inhibitor sample collection: 1) the need for the participant to administer alternative hemostatic products in order to achieve sufficient efficacy, 2) >=2 events indicating a decrease in the efficacy of the study treatment. Percentage of participants who developed clinically significant Factor VIII inhibitor after study drug administration were reported.
Time Frame
Baseline up to Month 24
Title
Incremental Recovery
Description
Incremental recovery was the increase in circulating FVIII activity for every international unit (IU) of ReFacto AF administered per kilogram of body weight. It was measured in international units per deciliter (IU/dL) per international units per kilogram (IU/kg).
Time Frame
Days 1, 15, 50, Months 6, 18 and Final visit (up to Month 24)
Title
Terminal Elimination Half Life of ReFacto AF (t1/2)
Description
T1/2 was the time for the plasma concentration of drug to decrease by one-half of its original concentration.
Time Frame
Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1
Title
Clearance (CL)
Description
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Time Frame
Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1
Secondary Outcome Measure Information:
Title
Mean Annualized Bleeding Rates (ABRs): All Participants
Description
ABR for each participant was calculated as the number of bleeds requiring administration of FVIII replacement product (taken from the Infusion Log Diary case report form), divided by the total therapy duration (in days), then multiplied by 365.25. ABR for the participants who reported following a primary or secondary prophylaxis, on-demand regimen or preventive regimen at baseline were reported.
Time Frame
Baseline up to Month 24
Title
Response to First On-Demand Treatment for New Bleeds: All Participants
Description
A 4-point scale of assessment of 'on-demand' treatment (administration of an unscheduled bolus infusion of Refacto-AF to stop bleeding) is defined as: 1. Excellent: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with no additional infusion administered. 2. Good: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with at least one additional infusion administered for complete resolution of the bleeding episode;or, Definite pain relief and/or improvement in signs of bleeding starting after 8 hours following infusion, with no additional infusion administered. 3. Moderate: Probable or slight improvement starting after 8 hours following the infusion, with at least one additional infusion administered for complete resolution of the bleeding episode. 4. No Response: No improvement at all between infusions or during the 24-hour interval following an infusion, or condition worsens.
Time Frame
Baseline up to Month 24
Title
Number of On-Demand ReFacto AF Infusions to Treat a New Bleed: All Participants
Description
The infusion log diary case report form (CRF) was used to determine the number of on-demand (administration of an unscheduled bolus infusion of Refacto-AF to stop bleeding) ReFacto AF infusions administered to treat a new bleed. This was calculated by adding the initial for a new bleed (on-demand) infusion to any subsequent (on-demand) infusions for the same "previously treated bleed" (same bleed with same start date/time).
Time Frame
Baseline up to Month 24
Title
Number of Breakthrough Bleeds Within 48 Hours of a Prophylaxis Dose of ReFacto AF: All Participants
Description
The number of breakthrough bleeds within 48 hours following a prophylaxis dose of ReFacto AF was summarized. The infusion log diary CRF was used to determine the number of infusions administered to treat a new bleed counting only those infusions which were administered <=48 hours after an infusion marked as "prophylaxis" (which had no associated bleed).
Time Frame
Baseline up to Month 24
Title
Average Infusion Dose of ReFacto AF: All Participants
Description
The average infusion dose (by weight) for each participant was calculated as his total factor FVIII consumption (in IU) divided by weight (in kg) divided by the number of infusions administered in total study duration. Data was reported separately for participants classified at baseline as following non-prophylaxis regimen (for example: on-demand regimen, preventive, or not specified), and participants classified at baseline following a primary or secondary prophylaxis regimen.
Time Frame
Baseline up to Month 24
Title
Total Factor VIII Consumption: All Participants
Description
Total factor VIII consumption for each participant was calculated by sum of the total amount of ReFacto AF (in IU) infused for each ReFacto AF infusion (recorded in the infusion log diary CRF). Data was reported separately for participants classified at baseline as following non-prophylaxis regimen (for example: on-demand regimen, preventive, or not specified), and participants classified at baseline following a primary or secondary prophylaxis regimen.
Time Frame
Baseline up to Month 24
Title
Number of Less-Than-Expected-Therapeutic Effect (LETE) Bleeds in the On-Demand Setting: All Participants
Description
LETE in on-demand setting was based on response to treatment of a bleeding episode. LETE in the on-demand setting occurred if participant recorded 2 successive "no response" ratings after 2 successive ReFacto AF infusions. Both infusions were to be administered at an interval of 24 hours for treatment of same bleeding event in absence of confounding factor which included: 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 greater than 4 hours between onset of bleed to infusion, delay of greater than 24 hours before administration of a follow-up infusion, known compromised ReFacto AF, faulty administration of ReFacto AF, participant had an underlying, predisposing condition responsible for bleed in opinion of investigator (e.g., kidney stones or use of medications known to impair platelet function, such as aspirin or NSAIDs),or ongoing trauma responsible for continued bleeding.
Time Frame
Baseline up to Month 24
Title
Number of Less-Than-Expected-Therapeutic Effect (LETE) Bleeds in the Prophylaxis Setting: All Participants
Description
LETE in the prophylaxis setting occurred if there was a spontaneous bleed within 48 hours (<=48 hours) after a regularly scheduled prophylactic dose of ReFacto AF (which was not used to treat a bleed) in the absence of confounding factors. Therefore, LETE in the prophylaxis setting is the occurrence of a bleed. Confounding factors include: Known presence or subsequent identification of a FVIII inhibitor, known inadequate prophylactic dose, known lack of adherence to the prescribed prophylaxis regimen, bleed occurs in a target joint identified at the start of the study, known compromised ReFacto AF, faulty administration of ReFacto AF, an underlying, predisposing condition responsible for the bleed in the opinion of the investigator (e.g., kidney stones or use of medications known to impair platelet function, such as aspirin or NSAIDs) or traumatic injury responsible for bleeding.
Time Frame
Baseline up to Month 24
Title
Number of Occurrences of Less-Than-Expected-Therapeutic Effect (LETE) in the Low Recovery Setting: All Participants
Description
LETE in the low recovery setting was defined as lower than expected recovery of FVIII (in the opinion of investigator), following the infusion of ReFacto AF in the absence of confounding factors for the low recovery. The only confounding factors for low recovery are as follows: known presence or subsequent identification of a FVIII inhibitor, known compromised ReFacto AF, faulty administration of ReFacto AF, including inadequate dosing.
Time Frame
Baseline up to Month 24
Title
Number of Participants Requiring Escalated Dose of Prescribed Regimen During the Treatment Period: All Participants
Description
Participants who met the dose escalation criteria were prescribed a higher dose and/or more frequent doses as per the investigator's discretion.
Time Frame
Baseline up to Month 24
Title
Plasma Concentration of Factor VIII at 0.5 Hour Post-dose (C0.5)
Time Frame
0.5 hour post-dose on Day 1
Title
Area Under the Plasma Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf)
Description
AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time. It was calculated as International units*hour per milliliter (IU*hr/mL).
Time Frame
Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1
Title
Area Under the Plasma Time Curve From Time Zero to Time of Last Measurable Concentration (AUClast)
Description
AUClast is the area under the plasma versus time curve from time zero to time of last measurable concentration (AUClast)
Time Frame
Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1
Title
Volume of Distribution at Steady State (Vss)
Description
Volume of distribution was defined as the theoretical volume in which the total amount of drug was uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) was the apparent volume of distribution at steady-state.
Time Frame
Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1
Title
Mean Residence Time (MRT) of ReFacto AF
Description
MRT was calculated as AUMCinf / AUCinf-TI/2, where AUMCinf is the area under the first moment curve from time zero to infinity and TI was the duration of infusion.
Time Frame
Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): All Participants
Description
An adverse event (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Time Frame
Baseline up to 30 days after last study visit (Month 25)
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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.
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
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70211
Country
Finland
Facility Name
LTD Medinvesti- Institute of hematology and transfusiology
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Centro di Riferimento Regionale per la cura dell'Emofilia e delle Malattie Emorragiche Congenite
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Spitalul Clinic Judetean de Urgenta Craiova
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200642
Country
Romania
Facility Name
Sanador
City
Bucharest
ZIP/Postal Code
011026
Country
Romania
Facility Name
University Children's Hospital
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Mother and Child Health Care Institute of Serbia "Dr Vukan Cupic"
City
Belgrade
ZIP/Postal Code
11070
Country
Serbia
Facility Name
Hospital Jerez de la Frontera
City
Jerez de la Frontera
State/Province
Cádiz
ZIP/Postal Code
11407
Country
Spain
Facility Name
Hospital Universitario Puerta del Mar
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Karolinska Universitetssjukhuset-Solna
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Cukurova University Department of Pediatrics, Pediatric Hematology Division
City
Adana
State/Province
Balcali/adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Ege University Department of Pediatrics, Pediatric Hematology Division
City
Izmir
State/Province
Bornova /izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Akdeniz Universitesi Tip Fakultesi
City
Antalya
State/Province
Kampus
ZIP/Postal Code
07059
Country
Turkey
Facility Name
Derzhavna ustanova "Instytut patolohii krovi ta transfuziinoi medytsyny Natsionalnoi akademii medych
City
Lviv
ZIP/Postal Code
79044
Country
Ukraine
Facility Name
Komunalna ustanova "Zaporizka oblasna klinichna dytiacha likarnia"
City
Zaporizhzhia
ZIP/Postal Code
69063
Country
Ukraine
12. IPD Sharing Statement
Links:
URL
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
Description
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Study Evaluating Safety And Efficacy Of Moroctocog Alfa (AF-CC) In Previously Treated Hemophilia A Patients
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