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Study of the Efficacy and Safety PF-06741086 in Adult and Teenage Participants With Severe Hemophilia A or Moderately Severe to Severe Hemophilia B

Primary Purpose

Hemophilia A, Hemophilia B

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PF-06741086
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophilia A focused on measuring Factor VIII, Factor IX, Inhibitors, Anti-Tissue Factor Pathway Inhibitor (TFPI), Subcutaneous (sc), Prophylaxis, On-Demand, BASIS, Inhibitor, SC, Subcutaneous, Injection, On demand, aTFPI, Anti-TFPI, Severe hemophilia, Severe bleeding, Hemophilia, PF-06741086, PF 06741086, Marstacimab

Eligibility Criteria

12 Years - 74 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria

  • Participants with a diagnosis of severe hemophilia A or moderately severe to severe hemophilia B with a minimum weight of 35 kg at screening.
  • Participant or legally authorized representative, or participant's caregiver capable of giving signed informed consent (or minor assent, when applicable).

Participants who are enrolled into the Non-Inhibitor Cohort must also meet the following criteria:

  • No detectable or documented history of inhibitors
  • Participants on FVIII/FIX routine prophylaxis who have demonstrated at least 80% compliance with scheduled prophylaxis regimen during 6 months prior to enrollment and are willing to continue to receive routine prophylaxis treatment with FVIII/FIX replacement during the Observational Phase.
  • Participants with on-demand treatment regimen with ≥6 acute bleeding episodes (spontaneous or traumatic) that required coagulation factor infusion during the 6 months period prior to enrollment and willing to continue to receive on demand treatment during the Observational Phase.

Participants who are enrolled into the Inhibitor Cohort must also meet the following criteria:

  • Documentation of current high titer inhibitor (≥5 BU/mL) or current low titer inhibitor (<5 BU/mL) refractory to FVIII or FIX replacement and with FVIII or FIX recovery <60% of expected within previous 6 months prior to enrolment into the Observational Phase
  • Hemophilia A participants with on-demand treatment regimen with ≥6 bleeding episodes or hemophilia B participants with ≥4 bleeding episodes (spontaneous or traumatic) necessitating treatment with bypass factor during the 6 months prior to Enrollment into Observational Phase and willing to continue to receive on-demand treatment during the Observational Phase.
  • Participants who have documented inhibitors while on factor-replacement therapy but who do not meet the quantitative inhibitor criteria described in the prior bullet at the time of Screening (eg, participant with a previously documented high-titer inhibitor (≥5 BU/mL) and whose condition precludes re-challenge with FVIII or FIX replacement) may be considered for eligibility on a case-by-case basis with prior agreement from the Pfizer Medical Monitor
  • Participants who meet the bleeding criteria noted above and who are on routine prophylaxis (defined as treatment by IV injection of bypass factor to prevent bleeding) and have demonstrated at least 80% compliance with scheduled prophylaxis regimen during the 6 months prior to enrollment, may be considered for eligibility on a case-by-case basis with discussion and agreement from the Pfizer medical monitor.

Exclusion Criteria

  • Previous or current treatment for and/or history of coronary artery diseases, venous or arterial thrombosis or ischemic disease
  • Known planned surgical procedure during the planned study period.
  • Known hemostatic defect other than hemophilia A or B.
  • Abnormal renal or hepatic function
  • Current unstable liver or biliary disease
  • Abnormal hematologic parameters
  • Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator,
  • Current routine prophylaxis with bypassing agent or non-coagulation non-factor- replacement therapy, or any previous treatment with a gene therapy product for treatment of hemophilia (participants treated with prophylaxis using bypassing agents or who had prior treatment with non-factor products may be considered on a case-by-case basis).
  • Regular, concomitant therapy with immunomodulatory drugs

    - Ongoing or planned use of immune tolerance induction during the Observational Phase or Active Treatment Phase, or prophylaxis with FVIII or FIX replacement at any time after initiation of treatment with study intervention during the Active Treatment Phase

  • Previous exposure to PF 06741086 during participation in studies B7841002 and B7841003.
  • Participation in other studies involving investigational drug(s) or investigational vaccines within 30 days (or as determined by local requirements) or 5 half-lives prior to study entry and/or during study participation.
  • CD4 cell count ≤200/uL if human immunodeficiency virus (HIV)-positive
  • Screening ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
  • Individuals with hypersensitivity or an allergic reaction to hamster protein or other components of the study intervention.
  • Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are Pfizer employees, including their family members, directly involved in the conduct of the study.

Sites / Locations

  • USF Health Morsani Center For Advanced Healthcare
  • University of IowaRecruiting
  • Northwell Health HTCRecruiting
  • Washington Institute for CoagulationRecruiting
  • National Specialized Hospital for the Active Treatment of Hematological Diseases - EAD, Sofia
  • UMHAT "Prof.Dr. Stoyan Kirkovich"
  • McMaster Children's HospitalRecruiting
  • McMaster University Medical Centre - Hamilton Health Sciences
  • McMaster Children's Hospital
  • McMaster University
  • The Hospital For Sick Children
  • Nanfang Hospital, Southern Medical University
  • The Affiliated Hospital of Guizhou Medical UniversityRecruiting
  • Jiangxi Provincial People's Hospital
  • Institute of Hematology, Chinese Academy of Medical SciencesRecruiting
  • Beijing Children's Hospital, Capital Medical UniversityRecruiting
  • Klinicki bolnicki centar Zagreb
  • Klinicki bolnicki centar ZagrebRecruiting
  • Hôpital Necker Enfants Malades
  • Prince of Wales Hospital
  • Queen Mary Hospital
  • Nirmal Hospital Pvt, LtdRecruiting
  • Sahyadri Clinical Research and Development CenterRecruiting
  • Sahyadri Super Speciality HospitalRecruiting
  • Christian Medical College
  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
  • Università degli Studi di Roma "Sapienza"-Policlinico Umberto I
  • Università degli Studi di Perugia, Azienda Ospedaliera di Perugia, Ospedale Santa Maria della
  • Nagoya University Hospital - Transfusion MedicineRecruiting
  • Sapporo Tokushukai HospitalRecruiting
  • Saitama Medical University HospitalRecruiting
  • Tokyo Metropolitan Children's Medical Center
  • Ogikubo Hospital
  • Hiroshima University HospitalRecruiting
  • Kyungpook National University Hospital
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Kyung Hee University Hospital At Gangdong
  • Hospital Universitario "Dr Jose Eleuterio Gonzalez"
  • Centro Multidisciplinario para el Desarrollo Especializado de la Inv. Clínica en Yucatán, S.C.P.Recruiting
  • Sultan Qaboos University Hospital
  • FGBOU VO "Samara State Medical University" of MoH of Russia
  • King Abdulaziz University Hospital
  • King Faisal Specialist Hospital & Research CenterRecruiting
  • Clinical Center of Serbia
  • Institute for Mother and Child healthcare "Dr Vukan Cupic"
  • Clinical Center Kragujevac
  • Clinical Center Nis
  • Charlotte Maxeke Johannesburg Academic HospitalRecruiting
  • Hospital Universitario A Coruna
  • Hospital Universitario Vall d´Hebron
  • Hospital Universitario La Paz
  • Hospital Universitario de Salamanca
  • Hospital Universitario Miguel Servet
  • ChangHua Christian Hospital
  • Taichung Veterans General Hospital
  • Acibadem Adana HospitalRecruiting
  • Hacettepe University Medical FacultyRecruiting
  • Hacettepe University Medical Faculty
  • Gazi University Health Research and Practice Center Gazi HospitalRecruiting
  • Akdeniz University Medical Faculty
  • Gaziantep University Sahinbey Research and Training Hospital
  • Istanbul University Oncology InstituteRecruiting
  • Ege University Medical Faculty
  • Ege University Medical FacultyRecruiting
  • Dr. Behcet Uz Child Diseases Surgery Education and Research Hospital
  • Erciyes University Medical Faculty
  • Ondokuz Mayıs University Medical FacultyRecruiting
  • Karadeniz Technical University Medical Faculty

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PF-06741086

Arm Description

Participants will be assigned to treatment with PF-06741086 after a 6 month Observation Phase on their current hemophilia regimen.

Outcomes

Primary Outcome Measures

Annualized bleeding rate (ABR) of treated bleeding events
Derived for each subject for each treatment period by using the following formula: ABR = number of bleeds requiring treatments/ (days on treatment period / 365.25)
Incidence and severity of thrombotic events
Incidence of anti drug antibody [ADA] against PF-06741086
Incidence of clinically significant persistent neutralizing antibody [NAb] against PF-06741086
Incidence and severity of injection site reaction
Number of participants with clinically significant changes from baseline in physical exam
Incidence of clinically significant laboratory value abnormalities
Incidence of severe hypersensitivity and anaphylactic reactions
Incidence of adverse events and serious adverse events
Number of participants with clinically significant changes from baseline in vital signs
Incidence and severity of thromboticangiopathy
Incidence of intravascular coagulation/consumption coagulopathy

Secondary Outcome Measures

Incidence of joint bleeds
Incidence of spontaneous bleeds
Incidence of target joint bleeds
Incidence of total bleeds (treated and untreated)
Change from baseline in the Hemophilia Joint Health Score (HJHS)
Change from baseline in (Haemophilia Adult Quality of Life Questionnaire (Haem-A-QoL)
Change from baseline in Haemophilia Quality of Life Questionnaire for Children (Haemo-QoL)
Change from baseline in Hemophilia Adult Activities List (HAL)
Change from baseline in Hemophilia Pediatric Activities List (PedHAL)
Patient Global Impression of Change - Hemophilia (PGIC-H)
Change from baseline in EuroQol 5 Dimensions 5 Level (EQ-5D-5L)

Full Information

First Posted
May 2, 2019
Last Updated
October 6, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03938792
Brief Title
Study of the Efficacy and Safety PF-06741086 in Adult and Teenage Participants With Severe Hemophilia A or Moderately Severe to Severe Hemophilia B
Official Title
An Open-Label Study in Adolescent and Adult Severe (Coagulation Factor Activity <1%) Hemophilia A Participants With or Without Inhibitors or Moderately Severe to Severe Hemophilia B Participants (Coagulation Factor Activity ≤2%) With or Without Inhibitors Comparing Standard Treatment to PF-06741086 Prophylaxis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2020 (Actual)
Primary Completion Date
September 27, 2024 (Anticipated)
Study Completion Date
September 27, 2024 (Anticipated)

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
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Treatment with PF-06741086 is anticipated to demonstrate a clinically relevant advantage and/or a major contribution to patient care in comparison to current methods of treatment for hemophilia A or B because it works differently than factor replacement products and will work in the presence of inhibitors. The potential for once weekly (QW) subcutaneous (SC) administration provides for treatment options in the absence of reliable vascular access, increased convenience and may enable better compliance. Combined, these qualities should result in a reduction of bleeding episodes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia A, Hemophilia B
Keywords
Factor VIII, Factor IX, Inhibitors, Anti-Tissue Factor Pathway Inhibitor (TFPI), Subcutaneous (sc), Prophylaxis, On-Demand, BASIS, Inhibitor, SC, Subcutaneous, Injection, On demand, aTFPI, Anti-TFPI, Severe hemophilia, Severe bleeding, Hemophilia, PF-06741086, PF 06741086, Marstacimab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Model Description
This is a one way Cross-Over Prevention study with 1 Arm that has No masking.
Masking
None (Open Label)
Allocation
N/A
Enrollment
145 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PF-06741086
Arm Type
Experimental
Arm Description
Participants will be assigned to treatment with PF-06741086 after a 6 month Observation Phase on their current hemophilia regimen.
Intervention Type
Drug
Intervention Name(s)
PF-06741086
Intervention Description
300 milligrams(mg) subcutaneous (sc) loading dose followed by 150 mg sq once weekly (qw). 300 mg sc qw is prescribed for participants who meet dose escalation criteria.
Primary Outcome Measure Information:
Title
Annualized bleeding rate (ABR) of treated bleeding events
Description
Derived for each subject for each treatment period by using the following formula: ABR = number of bleeds requiring treatments/ (days on treatment period / 365.25)
Time Frame
Through Observational Phase (6months) and Active Treatment Phase (12 months) for total of approximately 18 months
Title
Incidence and severity of thrombotic events
Time Frame
Through Observational Phase (6 months) and Active Treatment Phase (12 months) for total of approximately 18 months
Title
Incidence of anti drug antibody [ADA] against PF-06741086
Time Frame
Throughout Active Treatment Phase (12 months)
Title
Incidence of clinically significant persistent neutralizing antibody [NAb] against PF-06741086
Time Frame
Throughout Active Treatment Phase (12 months)
Title
Incidence and severity of injection site reaction
Time Frame
Throughout Active Treatment Phase (12 months)
Title
Number of participants with clinically significant changes from baseline in physical exam
Time Frame
From Baseline through Observation and Active Treatment (approximately 18 months)
Title
Incidence of clinically significant laboratory value abnormalities
Time Frame
From Screening through Observation and Active Treatment (approximately 18 months)
Title
Incidence of severe hypersensitivity and anaphylactic reactions
Time Frame
From Screening through Observational and Active Treatment (approximately 18 months)
Title
Incidence of adverse events and serious adverse events
Time Frame
From screening through Observation and Active treatment (approximately 18 months)
Title
Number of participants with clinically significant changes from baseline in vital signs
Time Frame
From Baseline through Observation and Active Treatment (approximately 18 months)
Title
Incidence and severity of thromboticangiopathy
Time Frame
Throughout Active Treatment Phase (12 months)
Title
Incidence of intravascular coagulation/consumption coagulopathy
Time Frame
Throughout Active Treatment Phase (12 months)
Secondary Outcome Measure Information:
Title
Incidence of joint bleeds
Time Frame
Through Observational Phase (6 months) and Active Treatment Phase (12 months) for total of approximately 18 months
Title
Incidence of spontaneous bleeds
Time Frame
Through Observational Phase (6 months) and Active Treatment Phase (12 months) for total of approximately 18 months
Title
Incidence of target joint bleeds
Time Frame
Through Observational Phase (6 months) and Active Treatment Phase (12 months) for total of approximately 18 months
Title
Incidence of total bleeds (treated and untreated)
Time Frame
Through Observational and Active Treatment Phases (18 Months)
Title
Change from baseline in the Hemophilia Joint Health Score (HJHS)
Time Frame
Through Observational Phase (6 months) and Active Treatment Phase (12 months) for total of approximately 18 months
Title
Change from baseline in (Haemophilia Adult Quality of Life Questionnaire (Haem-A-QoL)
Time Frame
Through Observational Phase (6 months) and Active Treatment Phase (12 months) for total of approximately 18 months
Title
Change from baseline in Haemophilia Quality of Life Questionnaire for Children (Haemo-QoL)
Time Frame
Through Observational Phase (6 months) and Active Treatment Phase (12 months) for total of approximately 18 months
Title
Change from baseline in Hemophilia Adult Activities List (HAL)
Time Frame
Through Observational Phase (6 months) and Active Treatment Phase (12 months) for total of approximately 18 months
Title
Change from baseline in Hemophilia Pediatric Activities List (PedHAL)
Time Frame
Through Observational Phase (6 months) and Active Treatment Phase (12 months) for total of approximately 18 months
Title
Patient Global Impression of Change - Hemophilia (PGIC-H)
Time Frame
Through Observational Phase (6 months) and Active Treatment Phase (12 months) for total of approximately 18 months
Title
Change from baseline in EuroQol 5 Dimensions 5 Level (EQ-5D-5L)
Time Frame
Through Observational Phase (6 months) and Active Treatment Phase (12 months) for total of approximately 18 months

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Participants with a diagnosis of severe hemophilia A or moderately severe to severe hemophilia B with a minimum weight of 35 kg at screening. Participant or legally authorized representative, or participant's caregiver capable of giving signed informed consent (or minor assent, when applicable). Participants who are enrolled into the Non-Inhibitor Cohort must also meet the following criteria: No detectable or documented history of inhibitors Participants on FVIII/FIX routine prophylaxis who have demonstrated at least 80% compliance with scheduled prophylaxis regimen during 6 months prior to enrollment and are willing to continue to receive routine prophylaxis treatment with FVIII/FIX replacement during the Observational Phase. Participants with on-demand treatment regimen with ≥6 acute bleeding episodes (spontaneous or traumatic) that required coagulation factor infusion during the 6 months period prior to enrollment and willing to continue to receive on demand treatment during the Observational Phase. Participants who are enrolled into the Inhibitor Cohort must also meet the following criteria: Documentation of current high titer inhibitor (≥5 BU/mL) or current low titer inhibitor (<5 BU/mL) refractory to FVIII or FIX replacement and with FVIII or FIX recovery <60% of expected within previous 6 months prior to enrolment into the Observational Phase Hemophilia A participants with on-demand treatment regimen with ≥6 bleeding episodes or hemophilia B participants with ≥4 bleeding episodes (spontaneous or traumatic) necessitating treatment with bypass factor during the 6 months prior to Enrollment into Observational Phase and willing to continue to receive on-demand treatment during the Observational Phase. Participants who have documented inhibitors while on factor-replacement therapy but who do not meet the quantitative inhibitor criteria described in the prior bullet at the time of Screening (eg, participant with a previously documented high-titer inhibitor (≥5 BU/mL) and whose condition precludes re-challenge with FVIII or FIX replacement) may be considered for eligibility on a case-by-case basis with prior agreement from the Pfizer Medical Monitor Participants who meet the bleeding criteria noted above and who are on routine prophylaxis (defined as treatment by IV injection of bypass factor to prevent bleeding) and have demonstrated at least 80% compliance with scheduled prophylaxis regimen during the 6 months prior to enrollment, may be considered for eligibility on a case-by-case basis with discussion and agreement from the Pfizer medical monitor. Exclusion Criteria Previous or current treatment for and/or history of coronary artery diseases, venous or arterial thrombosis or ischemic disease Known planned surgical procedure during the planned study period. Known hemostatic defect other than hemophilia A or B. Abnormal renal or hepatic function Current unstable liver or biliary disease Abnormal hematologic parameters Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, Current routine prophylaxis with bypassing agent or non-coagulation non-factor- replacement therapy, or any previous treatment with a gene therapy product for treatment of hemophilia (participants treated with prophylaxis using bypassing agents or who had prior treatment with non-factor products may be considered on a case-by-case basis). Regular, concomitant therapy with immunomodulatory drugs - Ongoing or planned use of immune tolerance induction during the Observational Phase or Active Treatment Phase, or prophylaxis with FVIII or FIX replacement at any time after initiation of treatment with study intervention during the Active Treatment Phase Previous exposure to PF 06741086 during participation in studies B7841002 and B7841003. Participation in other studies involving investigational drug(s) or investigational vaccines within 30 days (or as determined by local requirements) or 5 half-lives prior to study entry and/or during study participation. CD4 cell count ≤200/uL if human immunodeficiency virus (HIV)-positive Screening ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results. Individuals with hypersensitivity or an allergic reaction to hamster protein or other components of the study intervention. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are Pfizer employees, including their family members, directly involved in the conduct of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
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
USF Health Morsani Center For Advanced Healthcare
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Terminated
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwell Health HTC
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington Institute for Coagulation
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Name
National Specialized Hospital for the Active Treatment of Hematological Diseases - EAD, Sofia
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
UMHAT "Prof.Dr. Stoyan Kirkovich"
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Individual Site Status
Recruiting
Facility Name
McMaster University Medical Centre - Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
The Hospital For Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Terminated
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Affiliated Hospital of Guizhou Medical University
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550004
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangxi Provincial People's Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
306113
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Institute of Hematology, Chinese Academy of Medical Sciences
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Children's Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100045
Country
China
Individual Site Status
Recruiting
Facility Name
Klinicki bolnicki centar Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Active, not recruiting
Facility Name
Klinicki bolnicki centar Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Hôpital Necker Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Active, not recruiting
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Active, not recruiting
Facility Name
Nirmal Hospital Pvt, Ltd
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395002
Country
India
Individual Site Status
Recruiting
Facility Name
Sahyadri Clinical Research and Development Center
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Individual Site Status
Recruiting
Facility Name
Sahyadri Super Speciality Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Individual Site Status
Recruiting
Facility Name
Christian Medical College
City
Vellore
State/Province
Tamil NADU
ZIP/Postal Code
632004
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
City
Milano
State/Province
Milan
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Università degli Studi di Roma "Sapienza"-Policlinico Umberto I
City
Roma
State/Province
RM
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Università degli Studi di Perugia, Azienda Ospedaliera di Perugia, Ospedale Santa Maria della
City
Perugia
ZIP/Postal Code
06156
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Nagoya University Hospital - Transfusion Medicine
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sapporo Tokushukai Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
004-0041
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama Medical University Hospital
City
Iruma-gun
State/Province
Saitama
ZIP/Postal Code
350-0495
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Metropolitan Children's Medical Center
City
Fuchu
State/Province
Tokyo
ZIP/Postal Code
183-8561
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Ogikubo Hospital
City
Suginami-ku
State/Province
Tokyo
ZIP/Postal Code
167-0035
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kyung Hee University Hospital At Gangdong
City
Seoul
ZIP/Postal Code
05278
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario "Dr Jose Eleuterio Gonzalez"
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Centro Multidisciplinario para el Desarrollo Especializado de la Inv. Clínica en Yucatán, S.C.P.
City
Mérida
State/Province
Yucatán
ZIP/Postal Code
97130
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Sultan Qaboos University Hospital
City
Muscat
ZIP/Postal Code
123
Country
Oman
Individual Site Status
Active, not recruiting
Facility Name
FGBOU VO "Samara State Medical University" of MoH of Russia
City
Samara
ZIP/Postal Code
443079
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
King Abdulaziz University Hospital
City
Jeddah
ZIP/Postal Code
21589
Country
Saudi Arabia
Individual Site Status
Terminated
Facility Name
King Faisal Specialist Hospital & Research Center
City
Riyadh
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Active, not recruiting
Facility Name
Institute for Mother and Child healthcare "Dr Vukan Cupic"
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Active, not recruiting
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Individual Site Status
Active, not recruiting
Facility Name
Clinical Center Nis
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Individual Site Status
Active, not recruiting
Facility Name
Charlotte Maxeke Johannesburg Academic Hospital
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Hospital Universitario A Coruna
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Vall d´Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
ChangHua Christian Hospital
City
Changhua City
State/Province
Changhua County
ZIP/Postal Code
500
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Acibadem Adana Hospital
City
Adana
ZIP/Postal Code
01130
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Gazi University Health Research and Practice Center Gazi Hospital
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Akdeniz University Medical Faculty
City
Antalya
ZIP/Postal Code
07060
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Gaziantep University Sahinbey Research and Training Hospital
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Istanbul University Oncology Institute
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ege University Medical Faculty
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Ege University Medical Faculty
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Dr. Behcet Uz Child Diseases Surgery Education and Research Hospital
City
Izmir
ZIP/Postal Code
35210
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Erciyes University Medical Faculty
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Ondokuz Mayıs University Medical Faculty
City
Samsun
ZIP/Postal Code
55280
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Karadeniz Technical University Medical Faculty
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7841005
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Study of the Efficacy and Safety PF-06741086 in Adult and Teenage Participants With Severe Hemophilia A or Moderately Severe to Severe Hemophilia B

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