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| ID | Type | Description | Link |
|---|---|---|---|
| B1821009 | Other Identifier | Alias Study Number |
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The survey is intended to investigate the following matters, etc. under the actual use status after marketing in all patients who are administered this drug for a certain period of time after the launch.
Patients with hemophilia B (congenital blood coagulation factor IX deficiency) who are administered this drug.
Patients with hemophilia B are either patients for whom treatment was already started with a blood coagulation factor IX product ("Previously treated patients": hereinafter, "PTPs") or patients who have no history of treatment with a blood coagulation factor IX product in the past and for whom treatment will be started with this drug for the first time ("Previously untreated patients": hereinafter, "PUPs").
The definition of PUPs in this survey is "Patients in whom the total number of days of administration of a blood coagulation factor IX product other than this drug before administration of this drug was 3 exposure days (actual number of days of administration: hereinafter, "EDs") or less."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nonacog Alfa (Genetical Recombination) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nonacog Alfa (Genetical Recombination) | Drug | Patients with hemophilia B (congenital blood coagulation factor IX deficiency) who are administered this drug. Patients with hemophilia B are either patients for whom treatment was already started with a blood coagulation factor IX product ("Previously treated patients": hereinafter, "PTPs") or patients who have no history of treatment with a blood coagulation factor IX product in the past and for whom treatment will be started with this drug for the first time ("Previously untreated patients": hereinafter, "PUPs"). The definition of PUPs in this survey is "Patients in whom the total number of days of administration of a blood coagulation factor IX product other than this drug before administration of this drug was 3 exposure days (actual number of days of administration: hereinafter, "EDs") or less." |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Bleeding Episodes (Annual Bleeding Event Rate) During Periodic Replacement Therapy | Annual bleeding rate (ABR) was calculated as the number of total bleeding events occured during prophylaxis period devided by the period (events/year). ABR for other replacement treatment period was also calculated to evaluate the differences between types of treatment. If the period used for ABR calculation was less or equal than 7 days, the relevant data was regarded as missing. | 2 years for PTPs, 1 year for PUPs |
| Number of Administrations Required for Hemostasis for Bleeding Events | Mean number of administrations for hemostasis in replacement therapy for bleeding events. | 2 years for PTPs, 1 year for PUPs |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Evaluation of Each Therapeutic Administration for Bleeding Episodes | Propotion of subjects whose physicians evaluated the effect of BeneFIX for bleeding episodes as excellent or good was calculated. | 2 years for PTPs, 1 year for PUPs |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with hemophilia B (congenital blood coagulation factor IX deficiency) who are administered this drug.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo Medical University Hospital | Shinjuku-ku | Tokyo | Japan |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | BeneFIX (Nonacog Alfa) | Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician's discretion. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 314 participants completed the study. Of the 314 participants, 2 participants were excluded from the baseline analysis. One was excluded due to no information after first day of treatment and no drug administration, the other due to safety not assessable and no drug administration.
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| ID | Title | Description |
|---|---|---|
| BG000 | BeneFIX (Nonacog Alfa) | Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician's discretion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Number of Bleeding Episodes (Annual Bleeding Event Rate) During Periodic Replacement Therapy | Annual bleeding rate (ABR) was calculated as the number of total bleeding events occured during prophylaxis period devided by the period (events/year). ABR for other replacement treatment period was also calculated to evaluate the differences between types of treatment. If the period used for ABR calculation was less or equal than 7 days, the relevant data was regarded as missing. | Efficacy analysis set who recieved at least one administration and had at least one efficacy evaluation was used for this analysis. | Posted | Median | Inter-Quartile Range | Bleeding events/year | 2 years for PTPs, 1 year for PUPs |
|
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The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | BeneFIX (Nonacog Alfa) | Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician's discretion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herpes zoster | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D002836 | Hemophilia B |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D005164 | Factor IX |
| ID | Term |
|---|---|
| D004792 | Enzyme Precursors |
| D045762 | Enzymes and Coenzymes |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
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|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Previously Treated History | PTPs refer to previously treated patients. PUPs refer to previously untreated patients. | Number | Participants |
|
| Severity | The severity of heamophilia B was defined as follows; severe, blood coagulation factor IX activity less than 1%; moderate, 1% to 5%; mild, more than 1%. | Number | Participans |
|
| Number of Bleeding in the Past 1 Year | Number | Participants |
|
| History of Inhibitor | Number | Participants |
|
| Hemophilic Arthropathy | Number | Participants |
|
|
|
| Primary | Number of Administrations Required for Hemostasis for Bleeding Events | Mean number of administrations for hemostasis in replacement therapy for bleeding events. | Efficacy analysis set who recieved at least one administration and had at least one efficacy evaluation was used for this analysis. | Posted | Mean | Full Range | administrations | 2 years for PTPs, 1 year for PUPs | dosing for hemostasis | dosing for hemostasis |
|
|
|
| Secondary | Subjective Evaluation of Each Therapeutic Administration for Bleeding Episodes | Propotion of subjects whose physicians evaluated the effect of BeneFIX for bleeding episodes as excellent or good was calculated. | Efficacy analysis set who recieved at least one administration and had at least one efficacy evaluation was used for this analysis. | Posted | Number | 95% Confidence Interval | percentage | 2 years for PTPs, 1 year for PUPs | evaluations by physicians | evaluations by physicians |
|
|
|
| 5 |
| 312 |
| 35 |
| 312 |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pulmonary artery atresia | Congenital, familial and genetic disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Anti factor IX antibody positive | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Adenovirus infection | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 17.0 | Non-systematic Assessment |
|
| CD4 lymphocytes decreased | Investigations | MedDRA 17.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
| D011506 |
| Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |