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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-001623-38 | EudraCT Number |
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The purpose of this study is to evaluate whether Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM) is effective and safe in the treatment of hemophilia A patients who have not been treated with factor VIII (FVIII) before.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm - All Participants | Experimental | All subjects enrolled in the study who meet the eligibility criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Antihemophilic Factor Manufactured and Formulated without Added Human or Animal Proteins (rAHF-PFM) | Biological | Treatment regimens were determined by the investigator, and may have been any combination of standard prophylaxis (25 to 50 IU/kg body weight, 3 to 4 times per week), investigator-determined prophylaxis, and/or on-demand treatment (dose selected by investigator). The treatment of bleeding episodes and perioperative management was at the discretion of the investigator and consistent with the institution's standard of care. For incremental recovery assessments, a single infusion at 50 +/- 5 IU/kg was to be given. Immune tolerance induction (ITI) therapy for subjects who developed factor VIII inhibitors was at the discretion of the investigator, based on the institution's guidelines or described in peer-reviewed literature, and was to be approved by the sponsor's medical director. rAHF-PFM was to be administered intravenously via bolus infusion, except for perioperative management when it may have been given either by continuous or bolus infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Factor VIII Inhibitor Development | Percentage of treated participants who developed factor VIII inhibitors | Assessed during study period which was to be at least 75 exposure days or 3 years (whichever came first) |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding Episodes Treated With 1 to ≥4 Infusions | The number of bleeding episodes treated with 1, 2, 3, or ≥4 infusions of rAHF-PFM to achieve adequate hemostasis | Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first) |
| Assessment of Hemostasis for Treatment of Bleeding Episodes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
The subject has a history of exposure to factor VIII other than rAHF PFM or more than 3 infusions of commercially available rAHF PFM (i.e., ADVATE) within 28 days prior to screening, as determined by the subject's medical history. Any infusion of factor VIII replacement products prior to the 28-day period excludes the subject from participation
The subject has received more than 3 infusions of rAHF PFM (commercially available and/or study product) between screening and prior to the initial recovery infusion
The subject has a detectable inhibitor to factor VIII, as measured in the screening sample by the Nijmegen assay in the central laboratory
The subject has a history of inhibitor to factor VIII at any time prior to screening
The subject has a known hypersensitivity to rAHF PFM
The subject has any 1 of the following laboratory abnormalities at the time of screening:
The subject has an inherited or acquired hemostatic defect other than hemophilia A (e.g., qualitative platelet defect or von Willebrand's disease)
The subject is known to be seropositive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV), as determined by the subject's medical history
At the time of enrollment, the subject has a clinically significant chronic disease other than hemophilia A
The subject is currently participating in another investigational drug study, or has participated in any clinical study involving an investigational drug within 120 days of the screening visit
The subject (or the subject's legally authorized representative) is identified by the investigator as being unable or unwilling to cooperate with study procedures
The subject has received any blood product, including packed red blood cells (RBC), platelets, plasma, or cryoprecipitate
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Ewenstein B., Patrone L, Schroth P, Spotts G, Fritsch S, Pavlova B, Ehrlich H. Efficacy of antihemophilic factor (recombinant), plasma/albumin-free method (rAHF-PFM) in bleed prevention. J Thromb Haemost. 2007; 5(Suppl 2): P-S-179. | ||
| Result | Ewenstein B., Patrone L, Schroth P, Spotts G, Fritsch S, Pavlova B, Ehrlich H. Efficacy of antihemophilic factor (recombinant), plasma/albumin-free method (rAHF-PFM) in bleed treatment. J Thromb Haemost. 2007; 5(Suppl 2)v: P-S-180. | ||
| 19216617 | Result | Shapiro A, Gruppo R, Pabinger I, Collins PW, Hay CR, Schroth P, Casey K, Patrone L, Ehrlich H, Ewenstein BM. Integrated analysis of safety and efficacy of a plasma- and albumin-free recombinant factor VIII (rAHF-PFM) from six clinical studies in patients with hemophilia A. Expert Opin Biol Ther. 2009 Mar;9(3):273-83. doi: 10.1517/14712590902729392. | |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants screened for maximum 21 days. Study was not randomized; it was an open-label evaluation. Prior to initial infusion, a minimum washout period of 3 days was required. 11 participants who enrolled did not receive any rAHF-PFM infusions (3 withdrew consent, 6 screen failures, 1 non-compliance with screening, 1 pre-existing low hemoglobin)
Recruitment was conducted in the U.S., Canada, and Europe at 24 study sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Previously Untreated Patients (PUPs) | rAHF-PFM was dosed according to a therapeutic regimen which was determined by the investigator (ie: standard regimen [25 to 50 IU/kg body weight, 3 to 4 times per week]; a modified prophylactic regimen [dose and frequency selected by investigator] or on-demand treatment [dose selected by investigator]). The dosing regimen used to treat bleeding episodes (BEs) was at the discretion of the investigator and in accordance with the institution's standard of care for the type of bleeding episodes diagnosed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
Number of rAHF-PFM-treated bleeding episodes with treater assessment of hemostasis (4-point ordinal scale): Excellent: Full pain relief & bleeding cessation within ~8 hrs of 1 infusion. Additional infusions may have been given to maintain hemostasis; Good: Definite pain relief and/or improvement in bleeding within ~8 hrs after infusion. Possibly requires >1 infusion for complete resolution; Fair: Probable or slight relief of pain & slight improvement in bleeding within ~8 hrs after infusion. Requires >1 infusion for complete resolution; or None: No improvement or condition worsens. |
| Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first) |
| Annualized Rate of Bleeding Episodes | Number of bleeding episodes per subject annualized over 1 year for all etiologies | Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first) |
| Weekly rAHF-PFM Utilization | Weight-Adjusted Weekly Dose for Prophylaxis, On-Demand Treatment, and Perioperative Management. rAHF-PFM dose determined by the investigator (ie: standard regimen [25-50 IU/kg body weight, 3-4 times per week]; modified prophylactic regimen [dose and frequency selected by investigator] or on-demand treatment [dose selected by investigator]). Dosing to treat BEs was at investigator's discretion and in accordance with institution's standard of care. rAHF-PFM was administered I.V. via bolus infusion, except for perioperative management when it was given either by continuous or bolus infusion. | Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first) |
| In Vivo Incremental Recovery | Change in factor VIII concentration from pre- to post-infusion at initial and termination study visits. | 30 minutes pre-infusion to 30 minutes post-infusion |
| Assessment of Intra-operative Hemostasis | Number of surgical procedures managed with rAHF-PFM and with surgeon's assessment of hemostasis based on a 4-point ordinal scale: Excellent: ≤ average predicted blood loss for matched procedures in healthy individuals Good: > average predicted blood loss, but ≤ maximal predicted blood loss for matched procedures in healthy individuals Fair: > maximal predicted blood loss for matched procedures in healthy individuals, and hemostasis was achieved None: uncontrolled hemostasis with proper dosing, necessitating a change in treatment regimen | Assessed at the time of discharge from recovery room |
| Assessment of Postoperative Hemostasis | Number of surgical procedures managed with rAHF-PFM and with investigator's assessment of hemostasis based on a 4-point ordinal scale: Excellent: hemostasis was as good as or better than other licensed factor VIII products for matched procedure Good: hemostasis was probably as good as other licensed factor VIII products for matched procedure Fair: hemostasis was clearly < optimal for matched procedure, without need to change regimen None: bleeding from inadequate response with proper dosing, necessitating a change in regimen | Assessed at the time of discharge from hospital or clinic |
| Assessment of Blood Loss During Surgical Procedures | Percentage of actual intraoperative blood loss compared to preoperatively predicted average and maximal blood loss in hemostatically normal matched individuals (from institutional blood bank records) | Predicted volumes preoperatively estimated and actual volumes intraoperatively recorded |
| Adverse Events Deemed Related to Treatment | Percentage of participants who reported AEs deemed related to treatment with rAHF-PFM | Reported during the study period which was to be at least 75 exposure days or 3 years (whichever came first) |
| Development of Antibodies to Heterologous Proteins | Percentage of treated participants who developed antibodies to heterologous proteins (ie, Chinese Hamster Ovary Cell Protein, Murine IgG, or Recombinant Human VWF) | Assessed at baseline, throughout the duration of the study, which was to be at least 75 exposure days or 3 years (whichever came first), and at the termination visit. |
| Little Rock |
| Arkansas |
| United States |
| Los Angeles | California | United States |
| Washington D.C. | District of Columbia | United States |
| Atlanta | Georgia | United States |
| Chicago | Illinois | United States |
| Peoria | Illinois | United States |
| Indianapolis | Indiana | United States |
| Iowa City | Iowa | United States |
| New Orleans | Louisiana | United States |
| Ann Arbor | Michigan | United States |
| Detroit | Michigan | United States |
| Minneapolis | Minnesota | United States |
| New Hyde Park | New York | United States |
| New York | New York | United States |
| Philadelphia | Pennsylvania | United States |
| Houston | Texas | United States |
| Vienna | Austria |
| Toronto | Ontario | Canada |
| Caen | France |
| Le Kremlin-Bicêtre | France |
| Lyon | France |
| Marseille | France |
| Nantes | France |
| Paris | France |
| Bremen | Germany |
| Frankfurt | Germany |
| Hanover | Germany |
| Münster | Germany |
| Milan | Italy |
| San Juan | Puerto Rico |
| Barcelona | Spain |
| Stockholm | Sweden |
| Cardiff | Wales | United Kingdom |
| London | United Kingdom |
| Derived |
| Auerswald G, Thompson AA, Recht M, Brown D, Liesner R, Guzman-Becerra N, Dyck-Jones J, Ewenstein B, Abbuehl B. Experience of Advate rAHF-PFM in previously untreated patients and minimally treated patients with haemophilia A. Thromb Haemost. 2012 Jun;107(6):1072-82. doi: 10.1160/TH11-09-0642. Epub 2012 Apr 4. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PUPs |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | 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 | Factor VIII Inhibitor Development | Percentage of treated participants who developed factor VIII inhibitors | Participants who received at least 1 infusion of rAHF-PFM | Posted | Number | 95% Confidence Interval | percentage | Assessed during study period which was to be at least 75 exposure days or 3 years (whichever came first) |
|
|
| |||||||||||||||||||||||||
| Secondary | Bleeding Episodes Treated With 1 to ≥4 Infusions | The number of bleeding episodes treated with 1, 2, 3, or ≥4 infusions of rAHF-PFM to achieve adequate hemostasis | Participants who received at least 1 infusion of rAHF-PFM for the treatment of bleeding episodes | Posted | Number | Bleeding episodes | Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first) |
|
| |||||||||||||||||||||||||||
| Secondary | Assessment of Hemostasis for Treatment of Bleeding Episodes | Number of rAHF-PFM-treated bleeding episodes with treater assessment of hemostasis (4-point ordinal scale): Excellent: Full pain relief & bleeding cessation within ~8 hrs of 1 infusion. Additional infusions may have been given to maintain hemostasis; Good: Definite pain relief and/or improvement in bleeding within ~8 hrs after infusion. Possibly requires >1 infusion for complete resolution; Fair: Probable or slight relief of pain & slight improvement in bleeding within ~8 hrs after infusion. Requires >1 infusion for complete resolution; or None: No improvement or condition worsens. | Participants who received at least 1 infusion of rAHF-PFM and had at least 1 treated bleeding episode. The 1 rating of "none" was for the first 2 infusions, the last infusion was rated as "good". | Posted | Number | bleeding episodes | Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first) |
|
| |||||||||||||||||||||||||||
| Secondary | Annualized Rate of Bleeding Episodes | Number of bleeding episodes per subject annualized over 1 year for all etiologies | Participants treated for at least 3 months with investigator-defined on-demand treatment (for dose) or prophylaxis (for dose and infusion frequency) for >80% of the treatment period | Posted | Median | Full Range | bleeding episodes per subject per year | Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first) |
|
| ||||||||||||||||||||||||||
| Secondary | Weekly rAHF-PFM Utilization | Weight-Adjusted Weekly Dose for Prophylaxis, On-Demand Treatment, and Perioperative Management. rAHF-PFM dose determined by the investigator (ie: standard regimen [25-50 IU/kg body weight, 3-4 times per week]; modified prophylactic regimen [dose and frequency selected by investigator] or on-demand treatment [dose selected by investigator]). Dosing to treat BEs was at investigator's discretion and in accordance with institution's standard of care. rAHF-PFM was administered I.V. via bolus infusion, except for perioperative management when it was given either by continuous or bolus infusion. | Participants treated for at least 3 months with investigator-defined on-demand treatment (for dose) or prophylaxis (for dose and infusion frequency) for >80% of the treatment period | Posted | Median | Full Range | IU/kg | Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first) |
| |||||||||||||||||||||||||||
| Secondary | In Vivo Incremental Recovery | Change in factor VIII concentration from pre- to post-infusion at initial and termination study visits. | Participants who received pharmacokinetic rAHF-PFM infusions, did not develop inhibitors, and had assessments | Posted | Median | Full Range | IU/dL per IU/kg | 30 minutes pre-infusion to 30 minutes post-infusion |
|
| ||||||||||||||||||||||||||
| Secondary | Assessment of Intra-operative Hemostasis | Number of surgical procedures managed with rAHF-PFM and with surgeon's assessment of hemostasis based on a 4-point ordinal scale: Excellent: ≤ average predicted blood loss for matched procedures in healthy individuals Good: > average predicted blood loss, but ≤ maximal predicted blood loss for matched procedures in healthy individuals Fair: > maximal predicted blood loss for matched procedures in healthy individuals, and hemostasis was achieved None: uncontrolled hemostasis with proper dosing, necessitating a change in treatment regimen | Number of participants who underwent a surgical procedure with an intraoperative assessment of hemostatic efficacy | Posted | Number | Procedures | Assessed at the time of discharge from recovery room |
|
| |||||||||||||||||||||||||||
| Secondary | Assessment of Postoperative Hemostasis | Number of surgical procedures managed with rAHF-PFM and with investigator's assessment of hemostasis based on a 4-point ordinal scale: Excellent: hemostasis was as good as or better than other licensed factor VIII products for matched procedure Good: hemostasis was probably as good as other licensed factor VIII products for matched procedure Fair: hemostasis was clearly < optimal for matched procedure, without need to change regimen None: bleeding from inadequate response with proper dosing, necessitating a change in regimen | Number of participants who underwent a surgical procedure with a postoperative assessment of hemostatic efficacy | Posted | Number | Procedures | Assessed at the time of discharge from hospital or clinic |
|
| |||||||||||||||||||||||||||
| Secondary | Assessment of Blood Loss During Surgical Procedures | Percentage of actual intraoperative blood loss compared to preoperatively predicted average and maximal blood loss in hemostatically normal matched individuals (from institutional blood bank records) | Number of participants who underwent a surgical procedure with blood loss assessments | Posted | Median | Full Range | Percentage Blood Loss | Predicted volumes preoperatively estimated and actual volumes intraoperatively recorded |
|
| ||||||||||||||||||||||||||
| Secondary | Adverse Events Deemed Related to Treatment | Percentage of participants who reported AEs deemed related to treatment with rAHF-PFM | Participants who received at least 1 infusion of rAHF-PFM | Posted | Number | Percentage of Participants | Reported during the study period which was to be at least 75 exposure days or 3 years (whichever came first) |
|
| |||||||||||||||||||||||||||
| Secondary | Development of Antibodies to Heterologous Proteins | Percentage of treated participants who developed antibodies to heterologous proteins (ie, Chinese Hamster Ovary Cell Protein, Murine IgG, or Recombinant Human VWF) | Participants who received at least 1 infusion of rAHF-PFM and had assessments of heterologous antibodies | Posted | Number | Percentage of Participants | Assessed at baseline, throughout the duration of the study, which was to be at least 75 exposure days or 3 years (whichever came first), and at the termination visit. |
|
| |||||||||||||||||||||||||||
| Post-Hoc | Factor VIII Inhibitor Risk Factor: Genetic Risk Factor- Family History of Inhibitors | Number of treated participants who developed an inhibitor | Immunogenicity Analysis Set- Participants who developed an inhibitor or who were inhibitor-free with ≥10 exposure days to rAHF-PFM | Posted | Number | Participants | Duration of study which was to be at least 75 exposure days or 3 years (whichever came first) |
|
| |||||||||||||||||||||||||||
| Post-Hoc | Factor VIII Inhibitor Risk Factor: Race | Number of treated participants who developed an inhibitor | Immunogenicity Analysis Set- Participants who developed an inhibitor or who were inhibitor-free with ≥10 exposure days to rAHF-PFM | Posted | Number | Participants | Duration of study which was to be at least 75 exposure days or 3 years (whichever came first) |
|
| |||||||||||||||||||||||||||
| Post-Hoc | Factor VIII Inhibitor Risk Factor: Number of Participants With Intensive Treatment and High Dose (≤20 Exposure Days (EDs)) | Immunogenicity Analysis Set- Participants with 5 consecutive study days of a mean infusion dose of FVIII >50 IU/kg within ≤20 EDs who developed an inhibitor | Immunogenicity Analysis Set- Participants who developed an inhibitor or who were inhibitor-free with ≥10 exposure days to rAHF-PFM | Posted | Number | Participants | Duration of study which was to be at least 75 exposure days or 3 years (whichever came first) |
|
|
Study period was to be at least 75 exposure days or 3 years (whichever came first)
Median days on study was 498 (range: 82 to 1360) days. Median days of rAHF-PFM exposure was 76 (range: 1 to 414) exposure days.
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 | PUPs | 28 | 55 | 52 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Factor VIII inhibition | Blood and lymphatic system disorders | MedDRA (Unspecified) |
| ||
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (Unspecified) |
| ||
| Mouth injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) |
| ||
| Pyrexia | General disorders | MedDRA (Unspecified) |
| ||
| Bacteraemia | Infections and infestations | MedDRA (Unspecified) |
| ||
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) |
| ||
| Bronchitis | Infections and infestations | MedDRA (Unspecified) |
| ||
| Catheter bacteraemia | Infections and infestations | MedDRA (Unspecified) |
| ||
| Catheter related infection | Infections and infestations | MedDRA (Unspecified) |
| ||
| Catheter site haematoma | General disorders | MedDRA (Unspecified) |
| ||
| Contusion | Injury, poisoning and procedural complications | MedDRA (Unspecified) |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) |
| ||
| Dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) |
| ||
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) |
| ||
| Haematoma | Vascular disorders | MedDRA (Unspecified) |
| ||
| Head injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) |
| ||
| Pneumonia | Infections and infestations | MedDRA (Unspecified) |
| ||
| Respiratory syncytial virus infection | Infections and infestations | MedDRA (Unspecified) |
| ||
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (Unspecified) |
| ||
| Tongue injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA (Unspecified) |
| ||
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) |
| ||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) |
| ||
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) |
| ||
| Ear infection | Infections and infestations | MedDRA (Unspecified) |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) |
| ||
| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) |
| ||
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) |
| ||
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) |
| ||
| Conjuctivitis | Eye disorders | MedDRA (Unspecified) |
| ||
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) |
| ||
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) |
| ||
| Otitis media | Infections and infestations | MedDRA (Unspecified) |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) |
| ||
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA (Unspecified) |
| ||
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) |
| ||
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (Unspecified) |
| ||
| Bronchitis | Infections and infestations | MedDRA (Unspecified) |
| ||
| Influenza | Infections and infestations | MedDRA (Unspecified) |
| ||
| Pain | General disorders | MedDRA (Unspecified) |
| ||
| Pharyngitis | Infections and infestations | MedDRA (Unspecified) |
| ||
| Rhinitis | Infections and infestations | MedDRA (Unspecified) |
| ||
| Varicella | Infections and infestations | MedDRA (Unspecified) |
| ||
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) |
| ||
| Croup infectious | Infections and infestations | MedDRA (Unspecified) |
| ||
| Ear pain | Ear and labyrinth disorders | MedDRA (Unspecified) |
| ||
| Gasteroenteritis | Infections and infestations | MedDRA (Unspecified) |
| ||
| Mouth injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) |
| ||
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (Unspecified) |
| ||
| Viral infection | Infections and infestations | MedDRA (Unspecified) |
|
Baxter's agreements with PIs vary per individual PI, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication or 1 year after study completion. Baxter requires a review of results communications (e.g., for confidential information) 30 days prior to submission or communication. Baxter may request an additional delay of up to 90 days (e.g., to allow for intellectual property protection).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| 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 |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Title | Denominators | Categories |
|---|
| 1 infusion |
| |||||
| 2 infusions |
| |||||
| 3 infusions |
| |||||
| 4 or more infusions |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
The dosing regimen used to treat BEs was at the discretion of the investigator and in accordance with the institution's standard of care for the type of BE diagnosed.
| OG002 | PUPs -During Perioperative Management | rAHF-PFM was administered intravenously via bolus infusion, or continuous infusion. The dosing regimen used was at the discretion of the investigator and in accordance with the institution's standard of care. |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Blood loss as percentage of predicted average |
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| Blood loss as percentage of predicted maximal |
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| Denominators |
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| Categories |
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