Back to resultsA Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B (BENEGENE-2)
Primary Purpose
Hemophilia B
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PF-06838435/ fidanacogene elaparvovec
Sponsored by
About this trial
This is an interventional treatment trial for Hemophilia B focused on measuring PF 06838435, Hemophilia, Hemophilia B, Factor IX, FIX, Gene Therapy, Infusion, rAAV Spark100 hFIX Padua, rAAV Spark100-hFIX-R338L, R338L, BeneGene 2, Hematological Diseases, Annualized bleeding rate (ABR)
Eligibility Criteria
Inclusion Criteria
- Males who completed 6 months of routine Factor IX prophylaxis therapy during the lead-in study (C0371004) prior to providing consent at the screening visit for this study.
- Documented moderately severe to severe hemophilia B (Factor IX activity < =2%)
- Suspension of prophylaxis therapy for hemophilia B after administration of the study drug
- Laboratory values (hemoglobin, platelets and creatinine) within study specified limits
- Agree to contraception until components of the drug are eliminated from their body
- Capable of giving signed informed consent
Exclusion Criteria
- Anti-AAV Spark100 neutralizing antibodies (nAb) titer >= 1:1.
- History of inhibitor to Factor IX or inhibitor detected during screening.
- Clinical signs or symptoms of decreased response to Factor IX
- Hypersensitivity to Factor IX replacement product or intravenous immunoglobulin administration
- History of chronic infection or other chronic disease
- Any concurrent clinically significant major disease or condition
- Laboratory values at screening visit that are abnormal or outside acceptable study limits
- Significant and/or unstable liver disease, biliary disease, significant liver fibrosis
- Planned surgical procedure requiring Factor IX surgical prophylactic factor treatment 15 months from screening visit
- Use of restricted therapies (e.g., blood products, acetylsalicylic acid [aspirin] or ibuprofen, other investigational therapy, and by-passing agents)
- Previously dosed in a gene therapy research trial at any time or in an interventional clinical study within 12 weeks of screening visit
- Active hepatitis B or C; hepatitis B surface antigen (HBsAg), hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positivity, or hepatitis C virus (HCV) ribonucleic acid (RNA) positivity
- Serological evidence of human immunodeficiency virus HIV-1 or HIV-2 infection with either Cluster of Differentiation 4 positive (CD4+) cell count ≤200 mm3 or viral load >20 copies/mL
- Study and sponsor staff and their families involved in the conduct of the study
- Unable to comply with study procedures
- Sensitivity to heparin or heparin induced thrombocytopenia
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy
Sites / Locations
- University of California, San Francisco - Clinical Research CenterRecruiting
- University of California, San Francisco - Outpatient Hematology ClinicRecruiting
- Hemophilia and Thrombosis Center at the University of Colorado Anschutz Medical CampusRecruiting
- Indiana Hemophilia & Thrombosis Center, Inc.Recruiting
- Indiana Hemophilia and Thrombosis Center, IncRecruiting
- St. Vincent Hospital & Health Care Center, Inc.Recruiting
- Madison Radiological GroupRecruiting
- Mississippi Center for Advanced MedicineRecruiting
- Center for Human Phenomic Science CHPSRecruiting
- Center for Human Phenomic ScienceRecruiting
- Investigational Drug ServiceRecruiting
- Penn Blood Disorder CenterRecruiting
- Royal Prince Alfred HospitalRecruiting
- Royal Brisbane and Women's Hospital
- Royal Adelaide HospitalRecruiting
- The Alfred HospitalRecruiting
- Fiona Stanley HospitalRecruiting
- Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMPRecruiting
- Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti - HEMORIORecruiting
- Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti- HEMORIORecruiting
- McMaster University Medical Centre - Hamilton Health SciencesRecruiting
- Juravinski Hospital - Hamilton Health SciencesRecruiting
- St. Michael's HospitalRecruiting
- Hopital Cardiologique Louis Pradel - CRTHRecruiting
- Hopital NeckerRecruiting
- Vivantes Klinikum FriedrichshainRecruiting
- Vivantes Klinikum im FriedrichshainRecruiting
- Universitätsklinikum Bonn, Anstalt des öffentlichen RechtsRecruiting
- Universitätsklinikum BonnRecruiting
- General Hospital of Athens "LAIKO", 2nd Regional Blood Transfusion CenterRecruiting
- Sapporo Tokushukai HospitalRecruiting
- Nara Medical University Hospital
- Saitama Medical University HospitalRecruiting
- National Center for Child Health and DevelopmentRecruiting
- Kyung Hee University Hospital at Gangdong
- King Faisal Specialist Hospital and Research CentreRecruiting
- Skåne University Hospital, Department of Hematology, Oncology and Radiation PhysicsRecruiting
- ApoEx ABRecruiting
- Changhua Christian HospitalRecruiting
- Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
- Chung Shan Medical University Hospital
- Chung Shan Medical University
- Taichung Veterans General HospitalRecruiting
- National Taiwan University HospitalRecruiting
- Acibadem Adana HospitalRecruiting
- Gaziantep University Sahinbey Training and Research HospitalRecruiting
- Istanbul University Oncology InstituteRecruiting
- Ege University Medical Faculty HospitalRecruiting
- Newcastle upon Tyne Hospitals NHS FTRecruiting
- Newcastle upon Tyne Hospitals NHS FT
- Newcastle upon Tyne Hospitals NHS FTRecruiting
- Newcastle upon Tyne Hospitals NHS FT
- Glasgow Royal InfirmaryRecruiting
- Glasgow Royal Infirmary
- Newcastle upon Tyne Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PF-06838435/ fidanacogene elaparvovec
Arm Description
Outcomes
Primary Outcome Measures
Annualized bleeding rate (ABR) for total bleeds
Secondary Outcome Measures
Annualized bleeding rate (ABR) for treated bleeds
Annualized infusion rate (AIR) of exogenous Factor IX
Vector derived Factor IX activity (FIX:C) level at steady state
Factor IX consumption
Annualized number of bleeding events of specific type: spontaneous and traumatic, and untreated
Frequency of target joint bleeds
Percentage of the participants without bleeds
Change in joint health as measured by the Hemophilia Joint Health Score (HJHS) instrument
Patient Reported Outcome (PRO) instrument - Hemophilia Quality of Life (Haem A QoL) Physical Health domain
Patient Reported Outcome (PRO) instrument - Hemophilia Activities List (HAL) Complex Lower Extremity Activities Component Score
Annualized Bleeding Rate for total bleeds
Vector-derived FIX:C level by study visit and the geometric mean at each yearly interval
Annualized infusion rate (AIR) of exogenous Factor IX
ABR for treated bleeds
Annualized Factor IX consumption
Annualized number of bleeding events of specific type: spontaneous and traumatic, and untreated
Hemophilia Joint Health Score (HJHS)
Frequency of target joint bleeds
Patient Reported Outcome (PRO) instrument - Hemophilia Quality of Life (Haem A QoL) Physical Health domain
Patient Reported Outcome (PRO) instrument - Hemophilia Activities List (HAL) Complex Lower Extremity Activities Component Score
Incidence and severity of all adverse events collected during the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03861273
Brief Title
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Acronym
BENEGENE-2
Official Title
Phase 3, Open-label, Single-arm Study to Evaluate Efficacy and Safety of FIX Gene Transfer With PF-06838435 (rAAV-Spark100-hFIX-R338L) in Adult Male Participants With Moderately Severe to Severe Hemophilia B (FIX:C ≤2%) (BeneGene-2)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 29, 2019 (Actual)
Primary Completion Date
November 16, 2022 (Actual)
Study Completion Date
March 27, 2030 (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
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
This study will evaluate the efficacy and safety of PF-06838435 (a gene therapy drug) in adult male participants with moderately severe to severe hemophilia B (participants that have a Factor IX circulating activity of 2% or less). The gene therapy is designed to introduce genetic material into cells to compensate for missing or non-functioning Factor IX. Eligible study participants will have completed a minimum 6 months of routine Factor IX prophylaxis therapy during the lead in study (C0371004). Participants will be dosed once (intravenously) and will be evaluated over the course of 6 years. The main objective of the study will evaluate the annualized bleeding rate [ABR] for participants treated with gene therapy versus standard of care (SOC) therapy (FIX prophylaxis replacement regimen).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia B
Keywords
PF 06838435, Hemophilia, Hemophilia B, Factor IX, FIX, Gene Therapy, Infusion, rAAV Spark100 hFIX Padua, rAAV Spark100-hFIX-R338L, R338L, BeneGene 2, Hematological Diseases, Annualized bleeding rate (ABR)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PF-06838435/ fidanacogene elaparvovec
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
PF-06838435/ fidanacogene elaparvovec
Intervention Description
Gene Therapy
Primary Outcome Measure Information:
Title
Annualized bleeding rate (ABR) for total bleeds
Time Frame
Week 12 to Month 15 post PF-06838435 infusion
Secondary Outcome Measure Information:
Title
Annualized bleeding rate (ABR) for treated bleeds
Time Frame
Week 12 to Month 15 post PF-06838435 infusion
Title
Annualized infusion rate (AIR) of exogenous Factor IX
Time Frame
Week 12 to Month 15 post PF-06838435 infusion
Title
Vector derived Factor IX activity (FIX:C) level at steady state
Time Frame
Week 12 to Month 15 post PF-06838435 infusion
Title
Factor IX consumption
Time Frame
Week 12 to Month 15 post PF-06838435 infusion
Title
Annualized number of bleeding events of specific type: spontaneous and traumatic, and untreated
Time Frame
Week 12 to Month 15 post PF-06838435 infusion
Title
Frequency of target joint bleeds
Time Frame
Week 12 to Month 15 post PF-06838435 infusion
Title
Percentage of the participants without bleeds
Time Frame
Week 12 to Month 15 post PF-06838435 infusion
Title
Change in joint health as measured by the Hemophilia Joint Health Score (HJHS) instrument
Time Frame
12 months post PF-06838435 infusion
Title
Patient Reported Outcome (PRO) instrument - Hemophilia Quality of Life (Haem A QoL) Physical Health domain
Time Frame
12 months post PF-06838435 infusion
Title
Patient Reported Outcome (PRO) instrument - Hemophilia Activities List (HAL) Complex Lower Extremity Activities Component Score
Time Frame
12 months post PF-06838435 infusion
Title
Annualized Bleeding Rate for total bleeds
Time Frame
From Month 15 to Month 24, by yearly intervals after 24 months, and across 6 years of follow-up
Title
Vector-derived FIX:C level by study visit and the geometric mean at each yearly interval
Time Frame
From Month 15 to Month 24, by yearly intervals after 24 months, and across 6 years of follow-up
Title
Annualized infusion rate (AIR) of exogenous Factor IX
Time Frame
From Month 15 to Month 24, by yearly intervals after 24 months, and across 6 years of follow-up
Title
ABR for treated bleeds
Time Frame
From Month 15 to Month 24, by yearly intervals after 24 months, and across 6 years of follow-up
Title
Annualized Factor IX consumption
Time Frame
From Month 15 to Month 24, by yearly intervals after 24 months, and across 6 years of follow-up
Title
Annualized number of bleeding events of specific type: spontaneous and traumatic, and untreated
Time Frame
From Month 15 to Month 24, by yearly intervals after 24 months, and across 6 years of follow-up
Title
Hemophilia Joint Health Score (HJHS)
Time Frame
Annually for 6 years
Title
Frequency of target joint bleeds
Time Frame
From Month 15 to Month 24, by yearly intervals after 24 months, and across 6 years of follow-up
Title
Patient Reported Outcome (PRO) instrument - Hemophilia Quality of Life (Haem A QoL) Physical Health domain
Time Frame
Annually for 6 years
Title
Patient Reported Outcome (PRO) instrument - Hemophilia Activities List (HAL) Complex Lower Extremity Activities Component Score
Time Frame
Annually for 6 years
Title
Incidence and severity of all adverse events collected during the study
Time Frame
For the duration of 6 years after PF-06838435 infusion
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Males who completed 6 months of Factor IX prophylaxis therapy during the lead-in study (C0371004) prior to providing consent at the screening visit for this study.
Documented moderately severe to severe hemophilia B (Factor IX activity < =2%)
Previous experience with FIX therapy (=>50 documented exposure days to a FIX protein product)
Suspension of prophylaxis therapy for hemophilia B after administration of the study drug
Laboratory values (hemoglobin, platelets and creatinine) within study specified limits
Agree to contraception until components of the drug are eliminated from their body
Capable of giving signed informed consent
Exclusion Criteria
Anti-AAVRh74var neutralizing antibodies (nAb) titer above the established threshold (ie, positive for nAb).
History of inhibitor to Factor IX or inhibitor detected during screening. Clinical signs or symptoms of decreased response to Factor IX
Hypersensitivity to Factor IX replacement product or IV immunoglobulin administration
History of chronic infection or other chronic disease
Any conditions associated with increased thromboembolic risk
Concurrent clinically significant major disease or condition unsuitable for participation and/or may interfere with the interpretation of study results
Laboratory values at screening visit that are abnormal or outside acceptable study limits
Current unstable liver or biliary disease
Currently on antiviral therapy for hepatitis B or C
Planned surgical procedure requiring Factor IX surgical prophylactic factor treatment 15 months from screening visit
Use of restricted therapies (e.g., blood products, acetylsalicylic acid [aspirin] or ibuprofen, other investigational therapy, and by-passing agents)
Previously dosed in a gene therapy research trial at any time or in an interventional clinical study within 12 weeks of screening visit
Active hepatitis B or C; hepatitis B surface antigen, hepatitis B virus deoxyribonucleic acid positivity, or hepatitis C virus ribonucleic acid positivity
Significant liver disease
Serological evidence of HIV1 or HIV2 infection with either CD4+ cell count <=200 mm3 and/or a viral load >20 copies/mL
Study and sponsor staff involved in the conduct of the study and their families
Unable to comply with study procedures
Sensitivity to heparin or heparin induced thrombocytopenia
Sensitivity to any of the study interventions, or components thereof, or drug or other allergy
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
University of California, San Francisco - Clinical Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, San Francisco - Outpatient Hematology Clinic
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Name
Hemophilia and Thrombosis Center at the University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Indiana Hemophilia & Thrombosis Center, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Name
Indiana Hemophilia and Thrombosis Center, Inc
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Vincent Hospital & Health Care Center, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Name
Madison Radiological Group
City
Madison
State/Province
Mississippi
ZIP/Postal Code
39110
Country
United States
Individual Site Status
Recruiting
Facility Name
Mississippi Center for Advanced Medicine
City
Madison
State/Province
Mississippi
ZIP/Postal Code
39110
Country
United States
Individual Site Status
Recruiting
Facility Name
Center for Human Phenomic Science CHPS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Center for Human Phenomic Science
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational Drug Service
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Penn Blood Disorder Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Brisbane and Women's Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Name
Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP
City
Campinas
State/Province
SÃO Paulo
ZIP/Postal Code
13083-878
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti - HEMORIO
City
Rio de Janeiro
ZIP/Postal Code
20211-030
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti- HEMORIO
City
Rio de Janeiro
ZIP/Postal Code
20211-030
Country
Brazil
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
Recruiting
Facility Name
Juravinski Hospital - Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Individual Site Status
Recruiting
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Hopital Cardiologique Louis Pradel - CRTH
City
Bron
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Necker
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Name
Vivantes Klinikum Friedrichshain
City
Berlin
ZIP/Postal Code
10249
Country
Germany
Individual Site Status
Recruiting
Facility Name
Vivantes Klinikum im Friedrichshain
City
Berlin
ZIP/Postal Code
10249
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Bonn, Anstalt des öffentlichen Rechts
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Recruiting
Facility Name
General Hospital of Athens "LAIKO", 2nd Regional Blood Transfusion Center
City
Athens
ZIP/Postal Code
11527
Country
Greece
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
Nara Medical University Hospital
City
Kashihara
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Individual Site Status
Active, not 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
National Center for Child Health and Development
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
157-8535
Country
Japan
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
Not yet recruiting
Facility Name
King Faisal Specialist Hospital and Research Centre
City
Riyadh
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Name
Skåne University Hospital, Department of Hematology, Oncology and Radiation Physics
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
Individual Site Status
Recruiting
Facility Name
ApoEx AB
City
Malmö
ZIP/Postal Code
211 24
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Changhua Christian Hospital
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chung Shan Medical University Hospital
City
Taichung City
ZIP/Postal Code
40201
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Chung Shan Medical University
City
Taichung City
ZIP/Postal Code
40201
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Acibadem Adana Hospital
City
Adana
ZIP/Postal Code
01130
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Gaziantep University Sahinbey Training and Research Hospital
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
Individual Site Status
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 Hospital
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Newcastle upon Tyne Hospitals NHS FT
City
Newcastle Upon Tyne
State/Province
Tyne & Wear
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Newcastle upon Tyne Hospitals NHS FT
City
Newcastle Upon Tyne
State/Province
Tyne & Wear
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Newcastle upon Tyne Hospitals NHS FT
City
Newcastle upon Tyne
State/Province
Tyne & Wear
ZIP/Postal Code
NE2 4HH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Newcastle upon Tyne Hospitals NHS FT
City
Newcastle upon Tyne
State/Province
Tyne & Wear
ZIP/Postal Code
NE2 4HH
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Glasgow Royal Infirmary
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Glasgow Royal Infirmary
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Newcastle upon Tyne Hospitals NHS Foundation Trust
City
Newcastle upon Tyne
ZIP/Postal Code
NE2 4HH
Country
United Kingdom
Individual Site Status
Not yet 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=C0371002
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
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