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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000373-36 | EudraCT Number | ||
| 997HA402 | Other Identifier | Bioverativ Therapeutics Inc. |
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| Name | Class |
|---|---|
| Swedish Orphan Biovitrum | INDUSTRY |
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The primary purpose of this study was to describe the time to tolerization (i.e., ITI success) with rFVIIIFc in participants within a maximum of 48 weeks (12 months) of ITI treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant coagulation factor VIII Fc (rFVIIIFc) | Experimental | Participants were to receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 48 Weeks in ITI Period. Participants who met the criteria for immune tolerance induction (ITI) success entered the tapering period and received rFVIIIFc at a dose adjusted according to Investigator judgment based on the FVIII activity levels and with the aim of tapering the rFVIIIFc dose to reach a prophylactic dosing regimen within 16 weeks (4 months). Follow-Up was for 32 weeks under an adjusted prophylactic regimen according to Investigator judgment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rFVIIIFc | Biological | rFVIIIFc 200 IU/kg/day in ITI Period, 50 or 100 IU/kg (adjusted according to Investigator judgement) in tapering Period, and prophylactic regimen in Follow-Up period as powder for injection administered intravenously. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Tolerization With rFVIIIFc | Time required for participants to achieve immune tolerance induction (ITI) success where ITI success is defined as achieving all 3 of the following criteria: confirmed negative titers consisting of 2 consecutive negative inhibitor assessments within 2 weeks (less than [<] 0.6 Bethesda units/milliliter [mL] by the Nijmegen-modified Bethesda assay); incremental recovery (IR) greater than or equal to (>=) 66 percent (%) of the expected IR in 2 consecutive assessments; half-life (t½) >= 7 hours. | Up to 48 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Immune Tolerance Induction (ITI) Success | Number of participants who achieve ITI success where ITI success is defined as achieving all 3 of the following criteria: confirmed negative titers consisting of 2 consecutive negative inhibitor assessments within 2 weeks (<0.6 Bethesda units/mL by the Nijmegen-modified Bethesda assay); incremental recovery (IR) >= 66% of the expected IR at 2 consecutive assessments; half-life (t½) >=7 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Inherited Blood Disorders | Orange | California | 92868 | United States | ||
| University of Colorado Hemophilia & Thrombosis Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36735911 | Derived | Malec L, Van Damme A, Chan AKC, Spasova M, Jain N, Sensinger C, Dumont J, Lethagen S, Carcao M, Peyvandi F. Recombinant factor VIII Fc fusion protein for first-time immune tolerance induction: final results of the verITI-8 study. Blood. 2023 Apr 20;141(16):1982-1989. doi: 10.1182/blood.2022017780. |
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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
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Total 16 participants were screened, enrolled and received drug.
The study was conducted at 14 active centers in 7 countries between 08-Dec-2017 to 16-Feb-2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Recombinant Coagulation Factor VIII Fc (rFVIIIFc) | Participants were to receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 48 Weeks in ITI Period. Participants who met the criteria for immune tolerance induction (ITI) success entered the tapering period and received rFVIIIFc at a dose adjusted according to Investigator judgment based on the FVIII activity levels and with the aim of tapering the rFVIIIFc dose to reach a prophylactic dosing regimen within 16 weeks (4 months). Follow-Up was for 32 weeks under an adjusted prophylactic regimen according to Investigator judgment. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 11, 2019 | May 3, 2021 |
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|
| Up to 48 Weeks |
| Number of Participants Who Experienced Relapse | Number of Participants with ITI success who reaches the criteria for relapse (defined as confirmed positive inhibitor titer >= 0.6 BU/mL or abnormal recovery after tolerance is achieved, and t½ less than [<] 7 hours) evaluated during the Tapering or Follow-Up Periods | Up to 48 weeks (16 weeks Tapering period and 32 weeks follow-up period) |
| Annualized Bleeding Rates During ITI Period | A bleeding episode started from the first sign of a bleed and ended no more than 72 hours after the last treatment for the bleed, within which any symptoms of bleeding at the same location or injections less than or equal to 72 hours apart were considered the same bleeding episode. Annualized bleeding rate for a patient during the ITI period is defined as the number of bleeding episodes divided by the length of the ITI period in days* 365.25. | Up to 48 weeks |
| Annualized Bleeding Rates After ITI Period | A bleeding episode started from the first sign of a bleed and ended no more than 72 hours after the last treatment for the bleed, within which any symptoms of bleeding at the same location or injections less than or equal to 72 hours apart were considered the same bleeding episode. Annualized bleeding rate for a patient after the ITT period (for tapering and follow-up period) is defined as the number of bleeding episodes divided by the length of the period after the ITI period in days* 365.25. | Up to 48 weeks (16 weeks Tapering period and 32 weeks follow-up period) |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) as a Measure of Safety and Tolerability | An AE is any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition. | Up to 2 Years |
| Average Number of Days Missed From Work or School Per Month During ITI Period | Average number of days missed from school or work per month for a period (counting in non-missing diary days) is defined as number of the missing school/work days in the period divided by number of days with data entry in the period. Number of days per month missed from school or work is reported for those who attend school or have a job. | Up to 48 weeks |
| Average Number of Days Missed From Work or School Per Month After ITI Period | Average number of days missed from school or work per month for a period (counting in non-missing diary days) is defined as number of the missing school/work days in the period divided by number of days with data entry in the period. Number of days per month missed from school or work is reported for those who attend school or have a job. | Up to 48 weeks (16 weeks Tapering period & 32 weeks Follow-up period) |
| Annualized Number of Hospitalization Days During ITI Period | Annualized number of hospitalization days during a period for a patient is defined as the number of hospitalization days divided by the length of the period in days * 365.25. | Up to 48 weeks |
| Annualized Number of Hospitalization Days After ITI Period | Annualized number of hospitalization days during a period for a patient is defined as the number of hospitalization days divided by the length of the period in days * 365.25. | Up to 48 weeks (16 weeks Tapering period & 32 weeks Follow-up period) |
| Adherence to Treatment Regimen Overall Study Period | Adherence to treatment is based on prescribed daily dose for the overall study period which is defined as the percentage of administered doses versus the prescribed doses to a patient for the entire study duration. | Up to 2 Years |
| Annualized rFVIIIFc Consumption for Overall Study Period | Annualized rFVIIIFc consumption for a treatment period is the total nominal rFVIIIFc (IU/kg) / length of period in days * 365.25. | Up to 2 Years |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Indiana Hemophilia and Thrombosis Center | Indianapolis | Indiana | 46260 | United States |
| University of Iowa Children's Hospital | Iowa City | Iowa | 52242 | United States |
| Childrens Hospital of Michigan | Detroit | Michigan | 48201 | United States |
| Dayton Children's Hospital | Dayton | Ohio | 45404 | United States |
| El Paso Children's Hospital | El Paso | Texas | 79905 | United States |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | United States |
| Gulf States Hemophilia and Thrombophilia Center | Houston | Texas | 77030 | United States |
| Blood Center of Southeast Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| UMHAT "Sv. Georgi", EAD | Plovdiv | 4000 | Bulgaria |
| UMHAT 'Tsaritsa Yoanna - ISUL', EAD | Sofia | 1527 | Bulgaria |
| Children's & Women's Health Centre of British Columbia | Vancouver | British Columbia | V6H 3N1 | Canada |
| McMaster Children's Hospital | Hamilton | Ontario | L8N 3Z5 | Canada |
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Hôpital de la Timone | Marseille | Bouches-Du-Rhône | 13385 | France |
| CHU Besançon - Hôpital Jean Minjoz | Besançon | Doubs | 25030 | France |
| CHU de Toulouse - Hôpital Purpan | Toulouse | Haute Garonne | 31059 | France |
| Hemostase Clinique - Institut Cœur-Poumons (4eme étage aile est) | Lille | Nord | 59037 | France |
| Hôpital Necker - Enfants Malades | Paris | 75015 | France |
| Universitaetsklinikum Bonn AoeR | Bonn | North Rhine-Westphalia | 53127 | Germany |
| Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| Azienda Ospedaliera Pediatrica Santobono Pausillipon | Naples | 80122 | Italy |
| Ospedale San Bortolo di Vicenza | Vicenza | 36100 | Italy |
| Nagoya University Hospital | Nagoya | Aichi-ken | 466-8550 | Japan |
| St. Marianna University School of Medicine Hospital | Kawasaki | Kanagawa | 216-8511 | Japan |
| Nara Medical University Hospital | Kashihara-shi | Nara | 634-8521 | Japan |
| Hospital Universitari Vall d'Hebron | Barcelona | 8035 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| St Thomas' Hospital | London | Greater London | SE1 7EH | United Kingdom |
| John Radcliffe Hospital | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
| Royal Hospital for Children | Glasgow | Strathclyde | G514TF | United Kingdom |
|
| Tapering Period | Tapering Period Full Analysis Set (TPFAS): includes participants entering the tapering phase of the study |
|
| Follow-up Period | Follow-Up Period Full Analysis Set: includes all participants entering the follow-up phase in the study. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Recombinant Coagulation Factor VIII Fc (rFVIIIFc) | Participants were to receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 48 Weeks in ITI Period. Participants who met the criteria for immune tolerance induction (ITI) success entered the tapering period and received rFVIIIFc at a dose adjusted according to Investigator judgment based on the FVIII activity levels and with the aim of tapering the rFVIIIFc dose to reach a prophylactic dosing regimen within 16 weeks (4 months). Follow-Up was for 32 weeks under an adjusted prophylactic regimen according to Investigator judgment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Tolerization With rFVIIIFc | Time required for participants to achieve immune tolerance induction (ITI) success where ITI success is defined as achieving all 3 of the following criteria: confirmed negative titers consisting of 2 consecutive negative inhibitor assessments within 2 weeks (less than [<] 0.6 Bethesda units/milliliter [mL] by the Nijmegen-modified Bethesda assay); incremental recovery (IR) greater than or equal to (>=) 66 percent (%) of the expected IR in 2 consecutive assessments; half-life (t½) >= 7 hours. | Participants who are in ITI full analysis set (includes all participants receiving at least 1 infusion of rFVIIIFc) and achieved ITI success | Posted | Median | Inter-Quartile Range | weeks | Up to 48 Weeks |
|
|
| |||||||||||||||||||||||||
| Secondary | Number of Participants With Immune Tolerance Induction (ITI) Success | Number of participants who achieve ITI success where ITI success is defined as achieving all 3 of the following criteria: confirmed negative titers consisting of 2 consecutive negative inhibitor assessments within 2 weeks (<0.6 Bethesda units/mL by the Nijmegen-modified Bethesda assay); incremental recovery (IR) >= 66% of the expected IR at 2 consecutive assessments; half-life (t½) >=7 hours. | ITI full analysis set | Posted | Count of Participants | Participants | No | Up to 48 Weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced Relapse | Number of Participants with ITI success who reaches the criteria for relapse (defined as confirmed positive inhibitor titer >= 0.6 BU/mL or abnormal recovery after tolerance is achieved, and t½ less than [<] 7 hours) evaluated during the Tapering or Follow-Up Periods | Tapering Full analysis set | Posted | Count of Participants | Participants | No | Up to 48 weeks (16 weeks Tapering period and 32 weeks follow-up period) |
|
| ||||||||||||||||||||||||||
| Secondary | Annualized Bleeding Rates During ITI Period | A bleeding episode started from the first sign of a bleed and ended no more than 72 hours after the last treatment for the bleed, within which any symptoms of bleeding at the same location or injections less than or equal to 72 hours apart were considered the same bleeding episode. Annualized bleeding rate for a patient during the ITI period is defined as the number of bleeding episodes divided by the length of the ITI period in days* 365.25. | ITI full analysis set which excludes participants who were observed for less than 90 days during the period | Posted | Mean | Standard Deviation | episodes per participant per year | Up to 48 weeks |
| |||||||||||||||||||||||||||
| Secondary | Annualized Bleeding Rates After ITI Period | A bleeding episode started from the first sign of a bleed and ended no more than 72 hours after the last treatment for the bleed, within which any symptoms of bleeding at the same location or injections less than or equal to 72 hours apart were considered the same bleeding episode. Annualized bleeding rate for a patient after the ITT period (for tapering and follow-up period) is defined as the number of bleeding episodes divided by the length of the period after the ITI period in days* 365.25. | Tapering period full analysis set excluding participants who were observed for less than 90 days in the period. | Posted | Mean | Standard Deviation | episodes per participant per year | Up to 48 weeks (16 weeks Tapering period and 32 weeks follow-up period) |
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) as a Measure of Safety and Tolerability | An AE is any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition. | ITI full analysis set | Posted | Count of Participants | Participants | Up to 2 Years |
| ||||||||||||||||||||||||||||
| Secondary | Average Number of Days Missed From Work or School Per Month During ITI Period | Average number of days missed from school or work per month for a period (counting in non-missing diary days) is defined as number of the missing school/work days in the period divided by number of days with data entry in the period. Number of days per month missed from school or work is reported for those who attend school or have a job. | Participants of ITI full analysis set and who attend school or have a job | Posted | Mean | Standard Deviation | days | Up to 48 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Average Number of Days Missed From Work or School Per Month After ITI Period | Average number of days missed from school or work per month for a period (counting in non-missing diary days) is defined as number of the missing school/work days in the period divided by number of days with data entry in the period. Number of days per month missed from school or work is reported for those who attend school or have a job. | Participants of Tapering full analysis set and who attended school or have a job | Posted | Mean | Standard Deviation | days | Up to 48 weeks (16 weeks Tapering period & 32 weeks Follow-up period) |
|
| ||||||||||||||||||||||||||
| Secondary | Annualized Number of Hospitalization Days During ITI Period | Annualized number of hospitalization days during a period for a patient is defined as the number of hospitalization days divided by the length of the period in days * 365.25. | ITI Full analysis set but excluding patients who were observed for less than 90 days in the period. | Posted | Mean | Standard Deviation | days | Up to 48 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Annualized Number of Hospitalization Days After ITI Period | Annualized number of hospitalization days during a period for a patient is defined as the number of hospitalization days divided by the length of the period in days * 365.25. | Tapering Period Full analysis set but excluding patients who were observed for less than 90 days in the period. | Posted | Mean | Standard Deviation | days | Up to 48 weeks (16 weeks Tapering period & 32 weeks Follow-up period) |
|
| ||||||||||||||||||||||||||
| Secondary | Adherence to Treatment Regimen Overall Study Period | Adherence to treatment is based on prescribed daily dose for the overall study period which is defined as the percentage of administered doses versus the prescribed doses to a patient for the entire study duration. | ITI full analysis set | Posted | Mean | Standard Deviation | percentage of doses | Up to 2 Years |
|
| ||||||||||||||||||||||||||
| Secondary | Annualized rFVIIIFc Consumption for Overall Study Period | Annualized rFVIIIFc consumption for a treatment period is the total nominal rFVIIIFc (IU/kg) / length of period in days * 365.25. | ITI Full analysis set | Posted | Mean | Standard Deviation | international unit (IU)/kilograms (kg) | Up to 2 Years |
|
|
All Adverse Events (AEs) were collected from signature of the informed consent form up to end of the study (up to 2 years) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent AEs (TEAEs) i.e. defined as AEs that developed, worsened, or became serious on or after the first administration of rFVIIIFc. Analysis performed on ITI full analysis set (ITIFAS).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Recombinant Coagulation Factor VIII Fc (rFVIIIFc) | Participants were to receive rFVIIIFc at a dose of 200 international units (IU)/kilogram (kg) as once daily injections or divided on several injections per day at the discretion of the Investigator, starting at baseline visit up to maximum of 48 Weeks in ITI Period. Participants who met the criteria for immune tolerance induction (ITI) success entered the tapering period and received rFVIIIFc at a dose adjusted according to Investigator judgment based on the FVIII activity levels and with the aim of tapering the rFVIIIFc dose to reach a prophylactic dosing regimen within 16 weeks (4 months). Follow-Up was for 32 weeks under an adjusted prophylactic regimen according to Investigator judgment. | 0 | 16 | 9 | 16 | 15 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Complication associated with device | General disorders | MedDra 23.1 | Systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDra 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 23.1 | Systematic Assessment |
| |
| Vascular access site infection | Infections and infestations | MedDra 23.1 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDra 23.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDra 23.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDra 23.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDra 23.1 | Systematic Assessment |
| |
| Mouth injury | Injury, poisoning and procedural complications | MedDra 23.1 | Systematic Assessment |
| |
| Post procedural oedema | Injury, poisoning and procedural complications | MedDra 23.1 | Systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDra 23.1 | Systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDra 23.1 | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDra 23.1 | Systematic Assessment |
| |
| Focal dyscognitive seizures | Nervous system disorders | MedDra 23.1 | Systematic Assessment |
| |
| Device breakage | Product Issues | MedDra 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDra 23.1 | Systematic Assessment |
| |
| Lymphocytosis | Blood and lymphatic system disorders | MedDra 23.1 | Systematic Assessment |
| |
| Monocytosis | Blood and lymphatic system disorders | MedDra 23.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDra 23.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDra 23.1 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDra 23.1 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDra 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 23.1 | Systematic Assessment |
| |
| Administration site extravasation | General disorders | MedDra 23.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDra 23.1 | Systematic Assessment |
| |
| Catheter site extravasation | General disorders | MedDra 23.1 | Systematic Assessment |
| |
| Catheter site haematoma | General disorders | MedDra 23.1 | Systematic Assessment |
| |
| Catheter site swelling | General disorders | MedDra 23.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDra 23.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDra 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 23.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDra 23.1 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDra 23.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDra 23.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDra 23.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDra 23.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDra 23.1 | Systematic Assessment |
| |
| Gastritis viral | Infections and infestations | MedDra 23.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDra 23.1 | Systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDra 23.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDra 23.1 | Systematic Assessment |
| |
| Myringitis | Infections and infestations | MedDra 23.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDra 23.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDra 23.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDra 23.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDra 23.1 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDra 23.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDra 23.1 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDra 23.1 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDra 23.1 | Systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDra 23.1 | Systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDra 23.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDra 23.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDra 23.1 | Systematic Assessment |
| |
| Lip injury | Injury, poisoning and procedural complications | MedDra 23.1 | Systematic Assessment |
| |
| Mouth injury | Injury, poisoning and procedural complications | MedDra 23.1 | Systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDra 23.1 | Systematic Assessment |
| |
| Scratch | Injury, poisoning and procedural complications | MedDra 23.1 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDra 23.1 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDra 23.1 | Systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDra 23.1 | Systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDra 23.1 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDra 23.1 | Systematic Assessment |
| |
| Wrong product administered | Injury, poisoning and procedural complications | MedDra 23.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDra 23.1 | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDra 23.1 | Systematic Assessment |
| |
| Serum ferritin decreased | Investigations | MedDra 23.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDra 23.1 | Systematic Assessment |
| |
| Vitamin d deficiency | Metabolism and nutrition disorders | MedDra 23.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 23.1 | Systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDra 23.1 | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDra 23.1 | Systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDra 23.1 | Systematic Assessment |
| |
| Synovial disorder | Musculoskeletal and connective tissue disorders | MedDra 23.1 | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDra 23.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDra 23.1 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDra 23.1 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDra 23.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 23.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDra 23.1 | Systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDra 23.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDra 23.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDra 23.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDra 23.1 | Systematic Assessment |
| |
| Eczema infantile | Skin and subcutaneous tissue disorders | MedDra 23.1 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDra 23.1 | Systematic Assessment |
| |
| Red man syndrome | Skin and subcutaneous tissue disorders | MedDra 23.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDra 23.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDra 23.1 | Systematic Assessment |
| |
| Urticaria contact | Skin and subcutaneous tissue disorders | MedDra 23.1 | Systematic Assessment |
|
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Bioverativ, a Sanofi company | 800-633-1610 | 6 | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 25, 2021 | May 3, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C587014 | factor VIII-Fc fusion protein |
| D005169 | Factor VIII |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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