Back to resultsA Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia (ATLAS-NEO)
Primary Purpose
Hemophilia
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fitusiran
Clotting factor concentrates (CFC) or bypassing agents (BPA)
Antithrombin concentrate (ATIIIC)
Sponsored by
About this trial
This is an interventional treatment trial for Hemophilia
Eligibility Criteria
Inclusion Criteria: Diagnosis of severe congenital hemophilia A or B (FVIII <1% or FIX level ≤2%) as evidenced by a central laboratory measurement at screening or documented medical record evidence. For participants currently not on prophylaxis (CFC or BPA on-demand): A minimum of 4 bleeding episodes requiring BPA (inhibitor participants) or CFC (non-inhibitor participants) treatment within the last 6 months prior to screening. Willing and able to comply with the study requirements and to provide written informed consent and assent in the case of participants under the age of legal consent, per local and national requirements Exclusion Criteria: Known co-existing bleeding disorders other than congenital hemophilia A or B History of arterial or venous thromboembolism, not associated with an indwelling venous access History of intolerance to SC injection(s). Current participation in immune tolerance induction therapy (ITI) Prior gene therapy Current or prior participation in a fitusiran trial Current or prior participation in a gene therapy trial Received an investigational drug or device within 30 days prior to the screening visit or within 5 half-lives of the investigational drug (or device) prior to the screening visit, whichever is longer Presence of clinically significant liver disease AT activity <60% at Screening Co-existing thrombophilic disorder Hepatitis C virus antibody positive, except participants who have negative Hepatitis C viral load and no evidence of cirrhosis Presence of acute hepatitis, ie, hepatitis A, hepatitis E. Presence of acute or chronic hepatitis B infection Known to be HIV positive with CD4 count <200 cells/μL. Reduced renal function The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Center for Inherited Blood Disorders (CIBD)-Site Number:8400012Recruiting
- University of California San Diego-Site Number:8400011Recruiting
- University of Minnesota-Site Number:8400016Recruiting
- Hackensack University-Site Number:8400009Recruiting
- Northwell Health Hemostasis and Thrombosis Center-Site Number:8400015Recruiting
- University Hospitals of Cleveland-Site Number:8400001Recruiting
- Children's Medical Center of Dallas-Site Number:8400018Recruiting
- The Gulf States Hemophilia and Thrombophilia Center-Site Number:8400002Recruiting
- University Of Utah Health Sciences Center-Site Number:8400006Recruiting
- Medical College of Wisconsin-Site Number:8400007Recruiting
- Investigational Site Number :1240001Recruiting
- Investigational Site Number :1240002Recruiting
- Investigational Site Number :1560003Recruiting
- Investigational Site Number :1560001Recruiting
- Investigational Site Number :1560002Recruiting
- Investigational Site Number :2500003Recruiting
- Investigational Site Number :2500002Recruiting
- Investigational Site Number :2500001Recruiting
- Investigational Site Number :2760001Recruiting
- Investigational Site Number :3000001Recruiting
- Investigational Site Number :3560001Recruiting
- Investigational Site Number :3560003Recruiting
- Investigational Site Number :3800003Recruiting
- Investigational Site Number :3800001Recruiting
- Investigational Site Number :3800002Recruiting
- Investigational Site Number :3920001Recruiting
- Investigational Site Number :3920004Recruiting
- Investigational Site Number :3920003Recruiting
- Investigational Site Number :3920002Recruiting
- Investigational Site Number :4100001Recruiting
- Investigational Site Number :4100002Recruiting
- Investigational Site Number :4100003Recruiting
- Investigational Site Number :4840004Recruiting
- Investigational Site Number :4840001Recruiting
- Investigational Site Number :7100003Recruiting
- Investigational Site Number :7100001Recruiting
- Investigational Site Number :7240002Recruiting
- Investigational Site Number :7240001Recruiting
- Investigational Site Number :7240003Recruiting
- Investigational Site Number :1580003Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All participants
Arm Description
In standard of care (SOC) period, participants will receive on-demand or prophylactic treatment with clotting factor concentrates (CFCs) or bypassing agents (BPAs) for 6 months (from Day -168 to Day -1). In fitusiran treatment period, participants will receive subcutaneous fitusiran prophylaxis once every other month (Q2M) or once monthly (QM) for 36 months (from Day 1 to Day 1009). In case of bleeding events participants will receive IV CFCs or BPAs. Participants may receive Antithrombin concentrate (ATIIIC) as rescue medicine. .
Outcomes
Primary Outcome Measures
Annualized bleeding rate (ABR) in the fitusiran primary efficacy period
A bleeding episode is defined as any occurrence of hemorrhage that requires administration of CFCs or BPAs, e.g., hemarthrosis, muscle, or mucosal bleeding.
Secondary Outcome Measures
Annualized bleeding rate (ABR) while on fitusiran prophylaxis in the fitusiran primary efficacy period and ABR while on prophylaxis standard of care (SOC) in the SOC period
A bleeding episode is defined as any occurrence of hemorrhage that requires administration of CFCs or BPAs, e.g., hemarthrosis, muscle, or mucosal bleeding.
Annualized bleeding rate (ABR) while on fitusiran prophylaxis in the fitusiran primary efficacy period and ABR while on on-demand standard of care (SOC) in the SOC period
A bleeding episode is defined as any occurrence of hemorrhage that requires administration of CFCs or BPAs, e.g., hemarthrosis, muscle, or mucosal bleeding.
Annualized spontaneous bleeding rate in the fitusiran primary efficacy period and in the SOC period
A bleeding episode is defined as any occurrence of hemorrhage that requires administration of CFCs or BPAs, e.g., hemarthrosis, muscle, or mucosal bleeding.
A spontaneous bleeding episode is a bleeding event that occurs for no apparent or known reason, particularly into the joints, muscles, and soft tissues.
Annualized joint bleeding rate in the fitusiran primary efficacy period and in the SOC period
A bleeding episode is defined as any occurrence of hemorrhage that requires administration of CFCs or BPAs, e.g., hemarthrosis, muscle, or mucosal bleeding.
A joint bleeding episode is characterized by an unusual sensation in the joint ("aura") in combination with 1) increasing swelling or warmth over the skin over the joint, 2) increasing pain, or 3) progressive loss of range of motion or difficulty in using the limb as compared with baseline.
Change in Haem-A-QOL physical health score and total score during SOC and during fitusiran prophylaxis
The Haem-A-QoL will be provided to participants ≥17 years of age and includes 46 items contributing to 10 QoL domains (physical health, feelings, view of yourself, sports and leisure, work and school, dealing with hemophilia, treatment, future, family planning, partnership, and sexuality). Scoring for each item is based on a 5-point Likert scale (never, rarely, sometimes, often, and all the time), and higher scores represent greater impairment.
Annualized bleeding rate (ABR) in the fitusiran 18-month efficacy period
A bleeding episode is defined as any occurrence of hemorrhage that requires administration of CFCs or BPAs, e.g., hemarthrosis, muscle, or mucosal bleeding.
Annualized bleeding rate (ABR) in the fitusiran 36-month treatment period
A bleeding episode is defined as any occurrence of hemorrhage that requires administration of CFCs or BPAs, e.g., hemarthrosis, muscle, or mucosal bleeding.
Annualized weight-adjusted consumption of CFC/BPA
All CFC or BPA doses (including doses per kg body weight) administered during the study treatment will be recorded
Number of participants with adverse events
All AEs (serious or nonserious) will be collected from the signing of the informed consent form (ICF) until last AT follow up visit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05662319
Brief Title
A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia
Acronym
ATLAS-NEO
Official Title
A Phase 3, Single-arm, Multicenter, Multinational, Open-label, One-way Crossover Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged ≥ 12 Years With Severe Hemophilia A or B With or Without Inhibitory Antibodies to Factor VIII or IX
Study Type
Interventional
2. Study Status
Record Verification Date
September 29, 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
April 15, 2026 (Anticipated)
Study Completion Date
March 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
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
This is a multicenter, multinational, open-label, one-way cross-over, Phase 3, single-arm study for treatment of hemophilia.
The purpose of this study is to measure the frequency of treated bleeding episodes with fitusiran in male adult and adolescent (≥12 years old) participants with hemophilia A or B, with or without inhibitory antibodies to factor VIII or IX who have switched from their prior standard of care treatment.
The total study duration will be up to approximately 50 months (200 weeks, 1 study month is equivalent to 4 weeks) and will include:
A screening period up to approximately 60 days,
A standard of care (SOC) period of approximately 6 study months (24 weeks),
A fitusiran treatment period of approximately 36 study months (144 weeks),
An antithrombin (AT) follow-up period of approximately 6 study months (24 weeks) but may be shorter or longer depending on individual participants AT recovery.
The frequency for telephone visits will be approximately every 2 weeks. For site visits the frequency will be approximately every 8 weeks during the SOC period and approximately every 4 weeks during the fitusiran treatment period. If applicable and if allowed by local regulation, home and/or remote visits may be conducted during the study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Model Description
One way cross-over
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All participants
Arm Type
Experimental
Arm Description
In standard of care (SOC) period, participants will receive on-demand or prophylactic treatment with clotting factor concentrates (CFCs) or bypassing agents (BPAs) for 6 months (from Day -168 to Day -1). In fitusiran treatment period, participants will receive subcutaneous fitusiran prophylaxis once every other month (Q2M) or once monthly (QM) for 36 months (from Day 1 to Day 1009). In case of bleeding events participants will receive IV CFCs or BPAs. Participants may receive Antithrombin concentrate (ATIIIC) as rescue medicine.
.
Intervention Type
Drug
Intervention Name(s)
Fitusiran
Intervention Description
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous (SC)
Intervention Type
Drug
Intervention Name(s)
Clotting factor concentrates (CFC) or bypassing agents (BPA)
Intervention Description
Coagulation factor VIII (ATC code: B02BD02)
Coagulation factor IX (ATC code: B02BD04)
Coagulation factor VIIa (ATC code: B02BD08)
Factor VIII inhibitor bypassing activity (ATC code: B02BD03)
Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV)
Intervention Type
Drug
Intervention Name(s)
Antithrombin concentrate (ATIIIC)
Intervention Description
Antithrombin III (ATC code: B01AB02) Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV)
Primary Outcome Measure Information:
Title
Annualized bleeding rate (ABR) in the fitusiran primary efficacy period
Description
A bleeding episode is defined as any occurrence of hemorrhage that requires administration of CFCs or BPAs, e.g., hemarthrosis, muscle, or mucosal bleeding.
Time Frame
Day 169 to Day 505 (since the first dose of fitusiran)
Secondary Outcome Measure Information:
Title
Annualized bleeding rate (ABR) while on fitusiran prophylaxis in the fitusiran primary efficacy period and ABR while on prophylaxis standard of care (SOC) in the SOC period
Description
A bleeding episode is defined as any occurrence of hemorrhage that requires administration of CFCs or BPAs, e.g., hemarthrosis, muscle, or mucosal bleeding.
Time Frame
Day 169 to Day 505 (primary efficacy period) and Day -168 to Day -1 (SOC period)
Title
Annualized bleeding rate (ABR) while on fitusiran prophylaxis in the fitusiran primary efficacy period and ABR while on on-demand standard of care (SOC) in the SOC period
Description
A bleeding episode is defined as any occurrence of hemorrhage that requires administration of CFCs or BPAs, e.g., hemarthrosis, muscle, or mucosal bleeding.
Time Frame
Day 169 to Day 505 (primary efficacy period) and Day -168 to Day -1 (SOC period)
Title
Annualized spontaneous bleeding rate in the fitusiran primary efficacy period and in the SOC period
Description
A bleeding episode is defined as any occurrence of hemorrhage that requires administration of CFCs or BPAs, e.g., hemarthrosis, muscle, or mucosal bleeding.
A spontaneous bleeding episode is a bleeding event that occurs for no apparent or known reason, particularly into the joints, muscles, and soft tissues.
Time Frame
Day 169 to Day 505 (primary efficacy period) and Day -168 to Day -1 (SOC period)
Title
Annualized joint bleeding rate in the fitusiran primary efficacy period and in the SOC period
Description
A bleeding episode is defined as any occurrence of hemorrhage that requires administration of CFCs or BPAs, e.g., hemarthrosis, muscle, or mucosal bleeding.
A joint bleeding episode is characterized by an unusual sensation in the joint ("aura") in combination with 1) increasing swelling or warmth over the skin over the joint, 2) increasing pain, or 3) progressive loss of range of motion or difficulty in using the limb as compared with baseline.
Time Frame
Day 169 to Day 505 (primary efficacy period) and Day -168 to Day -1 (SOC period)
Title
Change in Haem-A-QOL physical health score and total score during SOC and during fitusiran prophylaxis
Description
The Haem-A-QoL will be provided to participants ≥17 years of age and includes 46 items contributing to 10 QoL domains (physical health, feelings, view of yourself, sports and leisure, work and school, dealing with hemophilia, treatment, future, family planning, partnership, and sexuality). Scoring for each item is based on a 5-point Likert scale (never, rarely, sometimes, often, and all the time), and higher scores represent greater impairment.
Time Frame
Day 1 (D1) to Day 505, and from D1 to Day 1009, and during SOC from Day-168 to D-1
Title
Annualized bleeding rate (ABR) in the fitusiran 18-month efficacy period
Description
A bleeding episode is defined as any occurrence of hemorrhage that requires administration of CFCs or BPAs, e.g., hemarthrosis, muscle, or mucosal bleeding.
Time Frame
Day 1 to Day 505
Title
Annualized bleeding rate (ABR) in the fitusiran 36-month treatment period
Description
A bleeding episode is defined as any occurrence of hemorrhage that requires administration of CFCs or BPAs, e.g., hemarthrosis, muscle, or mucosal bleeding.
Time Frame
Day 1 to Day 1009
Title
Annualized weight-adjusted consumption of CFC/BPA
Description
All CFC or BPA doses (including doses per kg body weight) administered during the study treatment will be recorded
Time Frame
Day -168 until Day 1009
Title
Number of participants with adverse events
Description
All AEs (serious or nonserious) will be collected from the signing of the informed consent form (ICF) until last AT follow up visit.
Time Frame
Date of signed ICF (Day -228 to Day -169) until last visit (approximately 50 months after date of signed ICF)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of severe congenital hemophilia A or B (FVIII <1% or FIX level ≤2%) as evidenced by a central laboratory measurement at screening or documented medical record evidence.
For participants currently not on prophylaxis (CFC or BPA on-demand): A minimum of 4 bleeding episodes requiring BPA (inhibitor participants) or CFC (non-inhibitor participants) treatment within the last 6 months prior to screening.
Willing and able to comply with the study requirements and to provide written informed consent and assent in the case of participants under the age of legal consent, per local and national requirements
Exclusion Criteria:
Known co-existing bleeding disorders other than congenital hemophilia A or B
History of arterial or venous thromboembolism, not associated with an indwelling venous access
History of intolerance to SC injection(s).
Current participation in immune tolerance induction therapy (ITI)
Prior gene therapy
Current or prior participation in a fitusiran trial
Current or prior participation in a gene therapy trial
Received an investigational drug or device within 30 days prior to the screening visit or within 5 half-lives of the investigational drug (or device) prior to the screening visit, whichever is longer
Presence of clinically significant liver disease AT activity <60% at Screening
Co-existing thrombophilic disorder
Hepatitis C virus antibody positive, except participants who have negative Hepatitis C viral load and no evidence of cirrhosis
Presence of acute hepatitis, ie, hepatitis A, hepatitis E.
Presence of acute or chronic hepatitis B infection
Known to be HIV positive with CD4 count <200 cells/μL.
Reduced renal function The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trial Transparency email recommended (Toll free number for US & Canada)
Phone
800-633-1610
Ext
option 6
Email
Contact-US@sanofi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Center for Inherited Blood Disorders (CIBD)-Site Number:8400012
City
Orange
State/Province
California
ZIP/Postal Code
92868-4306
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California San Diego-Site Number:8400011
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Minnesota-Site Number:8400016
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Individual Site Status
Recruiting
Facility Name
Hackensack University-Site Number:8400009
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwell Health Hemostasis and Thrombosis Center-Site Number:8400015
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospitals of Cleveland-Site Number:8400001
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Medical Center of Dallas-Site Number:8400018
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Name
The Gulf States Hemophilia and Thrombophilia Center-Site Number:8400002
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
University Of Utah Health Sciences Center-Site Number:8400006
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical College of Wisconsin-Site Number:8400007
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240001
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240002
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560003
City
Beijing
ZIP/Postal Code
100045
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560001
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560002
City
Jinan
ZIP/Postal Code
250013
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500003
City
Kremlin Bicetre
ZIP/Postal Code
94275
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500002
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500001
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760001
City
Berlin
ZIP/Postal Code
10249
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000001
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3560001
City
Pune-411011
ZIP/Postal Code
411 011
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3560003
City
Vellore
ZIP/Postal Code
632004
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800003
City
Rozzano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800001
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800002
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920001
City
Kashihara-shi
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920004
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920003
City
Nagoya
ZIP/Postal Code
4668560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920002
City
Saitama-shi
ZIP/Postal Code
330-8777
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100001
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100002
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
05278
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100003
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840004
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840001
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100003
City
Benoni
ZIP/Postal Code
1501
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100001
City
Parktown
ZIP/Postal Code
2193
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240002
City
La Coruña
State/Province
A Coruña [La Coruña]
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240001
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240003
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1580003
City
Taipei
ZIP/Postal Code
11031
Country
Taiwan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Learn more about this trial
A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia
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