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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005489-37 | EudraCT Number |
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This study will examine the long-term safety and efficacy of rIX-FP for the control and prevention of bleeding episodes in children and adults with severe hemophilia B. The study will include subjects who have not previously been treated with Factor IX products, subjects who previously completed a CSL-sponsored rIX-FP lead-in study and subjects requiring major non-emergency surgery who have not previously completed a CSL-sponsored rIX-FP lead-in study.
A surgical prophylaxis substudy will examine the efficacy of rIX-FP in subjects with hemophilia B who are undergoing non-emergency major or minor surgery. An additional substudy will examine the safety and PK of subcutaneous (SC) administration of rIX-FP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rIX-FP | Experimental | Subjects will administer rIX-FP by intravenous infusion as routine prophylaxis, prevention, and on-demand treatment during a treatment period of approximately 3 years. The routine prophylaxis treatment interval for previously treated patients may be changed at each scheduled 6-month follow-up assessment. On-demand treatment with rIX-FP will be used for all bleeding episodes requiring treatment. Subjects (other than those in France) may participate in a surgical 'substudy' in which rIX-FP may be administered before, during and after surgery. An additional substudy will examine the safety and PK of subcutaneous administration of rIX-FP. For previously untreated patients, subjects will administer rIX-FP intravenously as weekly prophylaxis and/or on-demand treatment during the first 12 months, and as weekly routine prophylaxis thereafter. The dose of rIX-FP administered will be based on the subject's previous rIX-FP use and/or pharmacokinetic data. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rIX-FP | Biological | Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Participants Who Developed Inhibitors Against Factor IX (FIX) | For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). For PUPs: up to 3 years or the time it takes to achieve 50 EDs. | |
| Mean Incremental Recovery of a 50 IU/kg Dose of CSL654 in Previously Untreated Patients (PUPs) | Incremental Recovery: The increase in plasma concentration per IU/kg of factor administered. | Approximately 30 minutes after infusion of CSL654 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Annualized Bleeding Rate (ABR) by Prophylaxis Regimen in Previously Treated Patients (PTPs) | For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). | |
| Spontaneous ABR by Prophylaxis Regimen in PTPs | For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). |
Not provided
Inclusion criteria:
Main study inclusion criteria:
For previously treated subjects, either:
Or:
For previously untreated subjects:
Surgery substudy inclusion criterion:
Subcutaneous substudy inclusion criteria:
Exclusion criteria:
Main study exclusion criteria:
For subjects who have previously completed a CSL-sponsored rIX-FP study:
For subjects requiring major non-emergency surgery who have not previously completed a CSL-sponsored rIX-FP lead-in study:
For previously untreated subjects:
The surgical substudy does not have any additional exclusion criteria, although subject(s) in France will not be eligible for the surgery sub-study.
Subcutaneous substudy exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Program Director | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | United States | ||
| Indiana Hemophilia & Thrombosis Center Inc. |
Approximately 115 male previously treated patients (PTPs) and previously untreated patients (PUPs) with hemophilia B were planned to be enrolled, including all eligible PTPs from CSLB-sponsored rIX-FP lead-in studies, approximately 10 PTPs who required major, nonemergency surgery, and approximately 20 PUPs.
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| ID | Title | Description |
|---|---|---|
| FG000 | CSL654 (PTPs) | Previously treated patients (PTPs) will administer CSL654 (rIX-FP) by intravenous infusion as routine prophylaxis, prevention, and on-demand treatment during a treatment period of approximately 5 years or the time it takes to reach 100 exposure days (EDs). The dose of rIX-FP administered will be based on the subject's previous rIX-FP use and/or pharmacokinetic data. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 3, 2020 | May 17, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Average Amount of CSL654 (rIX-FP) Consumed Per Month Per Subject During Routine Prophylaxis Treatment. | For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). For PUPs: up to 3 years or the time it takes to achieve 50 EDs. |
| Percentage of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and the Percentage of Participants With at Least One CSL654-related TEAE | For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). For PUPs: up to 3 years or the time it takes to achieve 50 EDs. |
| Number of Participants With Investigator's Overall Clinical Assessment of Hemostatic Efficacy for the Treatment of Major Bleeding Events With CSL654 in PUPs | The investigator will rate the efficacy of the rIX-FP treatment based on a hemostatic efficacy four point rating scale of excellent, good, moderate, or poor/no response. | Up to 3 years or the time it takes to achieve 50 EDs |
| Total ABR for On-demand Regimen vs. 14-Day Regimen in PTPs | For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). |
| Spontaneous ABR for On-demand Regimen vs. 14-Day Regimen in PTPs | For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). |
| Total ABR for Subjects >=12 Years: 7-Day Regimen vs. 14-Day Regimen in PTPs | For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). |
| Spontaneous ABR for Subjects >=12 Years: 7-Day Regimen vs. 14-Day Regimen in PTPs | For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). |
| Total ABR for Subjects >=12 Years: 7-Day Regimen vs. (10 or 14)-Day Regimen in PTPs | For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). |
| Spontaneous ABR for Subjects >=12 Years: 7-Day Regimen vs. (10 or 14)-Day Regimen in PTPs | For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). |
| Indianapolis |
| Indiana |
| 46260 |
| United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Utah | Salt Lake City | Utah | 84103 | United States |
| Royal Children's Hospital | Parkville | Victoria | 3052 | Australia |
| The Children's Hospital Westmead | Westmead | Victoria | 2145 | Australia |
| Department of Pediatrics, Medical University of Vienna | Vienna | 1090 | Austria |
| Medical University of Vienna, Vienna General Hospital | Vienna | 1090 | Austria |
| SHAT "Joan Pavel" ODD [Hemorrhagic Diathesis & Anemia] | Sofia | 1233 | Bulgaria |
| McMaster University | Hamilton | Ontario | L8L 2X2 | Canada |
| Fakultni nemocnice Brno | Brno | 62500 | Czechia |
| Fakultni Nemocrice Ostrava | Ostrava-Poruba | 708 52 | Czechia |
| Fakultni nemocnice v Motole | Prague | 15006 | Czechia |
| CHRU Hopital Morvan | Brest | 29609 | France |
| Hopital Louis Pradel | Bron | 69677 | France |
| Hopital Bicetre - Centre de Traitement del'Hemophilia | Le Kremlin-Bicêtre | 94275 | France |
| Hopital d'Enfants La Timonepital | Marseille | 13385 | France |
| Hopital Necker-Enfants Malades | Paris | 75015 | France |
| Institut fur experimentelle Hamatologie | Bonn | 53127 | Germany |
| Prof. Hess Kinderklinik | Bremen | 28177 | Germany |
| CRC Coagulation Research Centre GmbH | Duisburg | 47051 | Germany |
| Heinrich Heine University Dusseldorf | Düsseldorf | 40225 | Germany |
| Universtatsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Werlhof-Institute for Haemostasis and Thrombosis | Hanover | 30159 | Germany |
| Kurpfalzkrankenhaus Heidlerberg GmbH | Heidelberg | Germany |
| Chaim Sheba Medical Center | Tel Aviv | Israel |
| IRCCS Ospedale Maggiore[Centro emofilia e Trobosi] | Milan | 20122 | Italy |
| UOS Gestione e Organizzazione Funzlone Hub Emofilia | Parma | 43126 | Italy |
| Centro Malattie Emorragiche e Trombotiche Ospedale | Vicenza | 36100 | Italy |
| Nara Medical University Hospital | Kashihara | 634-8522 | Japan |
| University of Occupational and Environmental Health | Kitakyushu | Japan |
| Nagoya University Hospital | Nagoya | 466-8550 | Japan |
| The Hospital of Hyogo College of Medicine | Nishinomiya | Japan |
| Tokyo Medical University Hospital | Tokyo | 160-0023 | Japan |
| Ogikubo Hospital | Tokyo | 167-0035 | Japan |
| St. Marianna University, School of Medicine, Seibu Hospital | Yokohama | 241-0811 | Japan |
| National Blood Center | Kuala Lumpur | 50400 | Malaysia |
| Perpetual Succour Hospital | Cebu | 6000 | Philippines |
| Haemophilia Comprehensive Care Centre | Parktown | 2193 | South Africa |
| C.H.U. A Coruna | A Coruña | Spain |
| Hospital Vall Hebron | Barcelona | 08035 | Spain |
| H.U. La Paz | Madrid | 28046 | Spain |
| FG001 | CSL654 (PUPs) | Previously untreated patients (PUPs) will administer CSL654 (rIX-FP) by intravenous infusion as weekly prophylaxis and/or on-demand treatment during the first 12 months, and as weekly routine prophylaxis thereafter up to 3 years or the time it takes to achieve 50 EDs. The dose of rIX-FP administered will be based on the pharmacokinetic data. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CSL654 (PTPs) | Previously treated patients (PTPs) will administer CSL654 (rIX-FP) by intravenous infusion as routine prophylaxis, prevention, and on-demand treatment during a treatment period of approximately 5 years or the time it took to reach 100 exposure days (EDs). The dose of rIX-FP administered will be based on the subject's previous rIX-FP use and/or pharmacokinetic data. |
| BG001 | CSL654 (PUPs) | Previously untreated patients (PUPs) administered CSL654 (rIX-FP) intravenously as weekly prophylaxis and/or on-demand treatment during the first 12 months, and as weekly routine prophylaxis thereafter up to 3 years or the time it takes to achieve 50 EDs. The dose of rIX-FP administered will be based on the subject's previous rIX-FP use and/or pharmacokinetic data. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Safety Population (SP) was used. It was pre-specified in the Statistical Analysis Plan to collect age data separately for PTPs and PUPs and to not calculate the age for the total overall population. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | SP was used | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | SP was used | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | 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 | Total Number of Participants Who Developed Inhibitors Against Factor IX (FIX) | Safety Population (SP) consisted of all participants who received ≥ 1 dose of rIX-FP during this study | Posted | Count of Participants | Participants | For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). For PUPs: up to 3 years or the time it takes to achieve 50 EDs. |
|
|
| ||||||||||||||||||||||||||||||
| Primary | Mean Incremental Recovery of a 50 IU/kg Dose of CSL654 in Previously Untreated Patients (PUPs) | Incremental Recovery: The increase in plasma concentration per IU/kg of factor administered. | Pharmacokinetic (PK) Population consisted of participants who received ≥ 1 dose of rIX-FP and had a sufficient number of analyzable PK blood samples (ie, ≥ 1 PK parameter calculated) for the PK assessment of rIX-FP. Participants were excluded from the analyses if an insufficient number of analyzable PK samples was obtained to permit the evaluation of ≥ 1 PK parameter. Only PUPs were analyzed for this endpoint. | Posted | Mean | Standard Deviation | (IU/dL)/(IU/kg) | Approximately 30 minutes after infusion of CSL654 |
| ||||||||||||||||||||||||||||||
| Secondary | Total Annualized Bleeding Rate (ABR) by Prophylaxis Regimen in Previously Treated Patients (PTPs) | Efficacy Population (EP) consisted of all participants in the Safety Population (SP). Only PTPs were analyzed for this endpoint. Participants were assigned under multiple regimens during the study, but were counted only once in any given regimen group. Annualized Bleeding Rate was derived only for subjects who were on the given regimen for at least 12 weeks. | Posted | Mean | Standard Deviation | Bleeds/Year/Participant | For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). |
| |||||||||||||||||||||||||||||||
| Secondary | Spontaneous ABR by Prophylaxis Regimen in PTPs | EP. Only PTPs were analyzed for this endpoint. Participants may be assigned under multiple regimens during the study, but will be counted only once in any given regimen group. Annualized Bleeding Rate is derived only for subjects who are on the given regimen for at least 12 weeks. | Posted | Mean | Standard Deviation | Bleeds/Year/Participant | For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). |
| |||||||||||||||||||||||||||||||
| Secondary | Average Amount of CSL654 (rIX-FP) Consumed Per Month Per Subject During Routine Prophylaxis Treatment. | EP | Posted | Mean | Standard Deviation | IU/kg per month | For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). For PUPs: up to 3 years or the time it takes to achieve 50 EDs. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and the Percentage of Participants With at Least One CSL654-related TEAE | SP | Posted | Number | percentage of participants | For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). For PUPs: up to 3 years or the time it takes to achieve 50 EDs. |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Investigator's Overall Clinical Assessment of Hemostatic Efficacy for the Treatment of Major Bleeding Events With CSL654 in PUPs | The investigator will rate the efficacy of the rIX-FP treatment based on a hemostatic efficacy four point rating scale of excellent, good, moderate, or poor/no response. | EP. This endpoint was for PUPs only. No major bleeding events were reported. Therefore, no data for this endpoint. | Posted | Count of Participants | Participants | Up to 3 years or the time it takes to achieve 50 EDs |
| |||||||||||||||||||||||||||||||
| Secondary | Total ABR for On-demand Regimen vs. 14-Day Regimen in PTPs | EP. Only PTPs were analyzed for this endpoint. Participants may be assigned under multiple regimens during the study, but will be counted only once in any given regimen group. Number of participants analyzed are those who received at least 12 weeks of treatment in the respective regimen. | Posted | Mean | Standard Deviation | Bleeds/Year/Subject | For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). |
| |||||||||||||||||||||||||||||||
| Secondary | Spontaneous ABR for On-demand Regimen vs. 14-Day Regimen in PTPs | EP. Only PTPs were analyzed for this endpoint. Participants may be assigned under multiple regimens during the study, but will be counted only once in any given regimen group. Number of participants analyzed are those who received at least 12 weeks of treatment in the respective regimen. | Posted | Mean | Standard Deviation | Bleeds/Year/Subject | For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). |
| |||||||||||||||||||||||||||||||
| Secondary | Total ABR for Subjects >=12 Years: 7-Day Regimen vs. 14-Day Regimen in PTPs | EP. Only PTPs were analyzed for this endpoint. Participants may be assigned under multiple regimens during the study, but will be counted only once in any given regimen group. Number of participants analyzed are those who received at least 12 weeks of treatment in the respective regimen. | Posted | Mean | Standard Deviation | Bleeds/Year/Subject | For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). |
| |||||||||||||||||||||||||||||||
| Secondary | Spontaneous ABR for Subjects >=12 Years: 7-Day Regimen vs. 14-Day Regimen in PTPs | EP. Only PTPs were analyzed for this endpoint. Participants may be assigned under multiple regimens during the study, but will be counted only once in any given regimen group. Number of participants analyzed are those who received at least 12 weeks of treatment in the respective regimen. | Posted | Mean | Standard Deviation | Bleeds/Year/Subject | For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). |
| |||||||||||||||||||||||||||||||
| Secondary | Total ABR for Subjects >=12 Years: 7-Day Regimen vs. (10 or 14)-Day Regimen in PTPs | EP. Only PTPs were analyzed for this endpoint. Participants may be assigned under multiple regimens during the study, but will be counted only once in any given regimen group. Number of participants analyzed are those who received at least 12 weeks of treatment in the respective regimen. | Posted | Mean | Standard Deviation | Bleeds/Year/Subject | For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). |
| |||||||||||||||||||||||||||||||
| Secondary | Spontaneous ABR for Subjects >=12 Years: 7-Day Regimen vs. (10 or 14)-Day Regimen in PTPs | EP. Only PTPs were analyzed for this endpoint. Participants may be assigned under multiple regimens during the study, but will be counted only once in any given regimen group. Number of participants analyzed are those who received at least 12 weeks of treatment in the respective regimen. | Posted | Mean | Standard Deviation | Bleeds/Year/Subject | For PTPs: up to 5 years or the time it takes to achieve 100 exposure days (EDs). |
|
For PTPs: up to 5 years or the time it took to achieve 100 exposure days (EDs). For PUPs: up to 3 years or the time it took to achieve 50 EDs.
Safety Population was used.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CSL654 (PTPs) | Previously treated patients (PTPs) will administer CSL654 (rIX-FP) by intravenous infusion as routine prophylaxis, prevention, and on-demand treatment during a treatment period of approximately 5 years or the time it took to reach 100 exposure days (EDs). The dose of rIX-FP administered will be based on the subject's previous rIX-FP use and/or pharmacokinetic data. | 1 | 83 | 17 | 83 | 69 | 83 |
| EG001 | CSL654 (PUPs) | Previously untreated patients (PUPs) administered CSL654 (rIX-FP) intravenously as weekly prophylaxis and/or on-demand treatment during the first 12 months, and as weekly routine prophylaxis thereafter up to 3 years or the time it takes to achieve 50 EDs. The dose of rIX-FP administered will be based on the subject's previous rIX-FP use and/or pharmacokinetic data. | 0 | 12 | 5 | 12 | 11 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematoma | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Peripheral Ischaemia | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Extradural Haematoma | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Muscle injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Serum ferritin decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Anti factor IX antibody increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haemophilic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abscess Jaw | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Selective IgA immunodeficiency | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Catheter site bruise | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Mouth injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Accident | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Tongue injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Factor VII deficiency | Congenital, familial and genetic disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Tongue biting | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Teething | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gingival disorder | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nail bed inflammation | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Soft tissue swelling | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haemophilic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Eyelid boil | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Otitis media chronic | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Otitis media viral | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | CSL Behring | 610-878-4000 | clinicaltrials@cslbehring.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 11, 2020 | May 17, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002836 | Hemophilia B |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
Not provided
Not provided
| ID | Term |
|---|---|
| C000618231 | albutrepenonacog alfa |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
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| CSL654 (PUPs) |
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| Austria |
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| Italy |
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| South Africa |
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| Israel |
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| Bulgaria |
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| Australia |
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| France |
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| Germany |
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