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This study is to describe the safety and efficacy of Xyntha® during the usual care setting.
non probability sample
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xyntha group | Xyntha will be administered according to physician's discretion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xyntha : coagulation factor IIIV (recombinant) | Drug | Xyntha will be administered according to physician's discretion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants by Family History of Factor VIII Inhibitor | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy (All Participants) | 4 years | |
| Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Less Than (<)18 Years of Age | 4 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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Hemophilia A
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei Rehabilitation Clinic | Guro-gu | Seoul | 152-834 | South Korea | ||
| Kim Hugh Chul Internal Medicine Clinic |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Xyntha | Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Xyntha | Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Participants by Family History of Factor VIII Inhibitor | All enrolled participants. | Posted | Number | percentage of participants | 4 years |
|
|
Adverse events were collected up to 6 months after the first administration of Xyntha.
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another subject, or one participant 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 | Xyntha | Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | WHOART v092 | 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 |
|---|---|
| D006467 | Hemophilia A |
| 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 |
|---|---|
| C078147 | F8 protein, human |
| C427184 | recombinant factor VIII SQ |
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| Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Greater Than or Equal to (≥) 18 Years of Age | 4 years |
| Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy (All Participants) | Response categories were excellent, good, moderate, or no response. | 4 years |
| Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants <18 Years of Age | Response categories were excellent, good, moderate, or no response. | 4 years |
| Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants ≥18 Years of Age | Response categories were excellent, good, moderate, and no response. | 4 years |
| Number of Participants With Less-Than-Expected Therapeutic Effect (LETE) for On-Demand Therapy | Less than expected therapeutic effect was defined as a 'no response' rating after each of two successive infusions less than or equl to (≤) 24 hours of on-demand therapy. | 4 years |
| Average Infusion Dose Per Bleeding for On-Demand Therapy (All Participants) | 4 years |
| Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants <18 Years of Age | 4 years |
| Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants ≥18 Years of Age | 4 years |
| Percentage of Participants Experiencing Hemorrhages During Prophylaxis | 4 years |
| Annualized Bleeding Rates During Prophylaxis | Annualized bleeding rate defined as total number of breakthrough bleeds within 48 hours (for prophylaxis purpose) divided by (/) [(total period of date of bleeding)/365.25)] | 4 years |
| Number of Participants With LETE Bleeds Within 48 Hours of a Preventive/Prophylaxis Dose of Xyntha | Less than expected therapeutic effect for prophylaxis therapy defined as breakthrough (spontaneous/non-traumatic) bleed wtihin 48 hours of prophylaxis infusion. | 4 years |
| Average Infusion Dose During Prophylaxis (All Participants) | 4 years |
| Average Infusion Dose During Prophylaxis in Participants <18 Years of Age | 4 years |
| Average Infusion Dose During Prophylaxis in Participants ≥18 Years of Age | 4 years |
| Total Factor Consumption for On-Demand Therapy and During Prophylaxis (All Participants) | 4 years |
| Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants <18 Years of Age | 4 years |
| Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants ≥18 Years of Age | 4 years |
| Songpa-gu |
| Seoul |
| 138-879 |
| South Korea |
| Pusan National University Hospital | Busan | 632-739 | South Korea |
| Kyung Hee University Hospital at Gangdong | Seoul | 134-727 | South Korea |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy (All Participants) | All enrolled participants; only participants who received on-demand therapy were included in the analysis. | Posted | Mean | Standard Deviation | infusions | 4 years |
|
|
|
| Secondary | Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Less Than (<)18 Years of Age | All enrolled participants; only participants aged <18 years who received on-demand therapy were included in the analysis. | Posted | Mean | Standard Deviation | infusions | 4 years |
|
|
|
| Secondary | Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Greater Than or Equal to (≥) 18 Years of Age | All enrolled participants; participants aged ≥18 years who received on-demand therapy were included in the analysis. | Posted | Mean | Standard Deviation | infusions | 4 years |
|
|
|
| Secondary | Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy (All Participants) | Response categories were excellent, good, moderate, or no response. | All enrolled participants; only participants who received on-demand therapy were included in the analysis. | Posted | Number | Number of responses | 4 years | infusions | Participants |
|
|
|
| Secondary | Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants <18 Years of Age | Response categories were excellent, good, moderate, or no response. | All enrolled participants; only participants <18 years who received on-demand therapy were included in the analysis. | Posted | Number | number of responses | 4 years | infusions | Participants |
|
|
|
| Secondary | Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants ≥18 Years of Age | Response categories were excellent, good, moderate, and no response. | All enrolled participants; only participants ≥18 years who receive don-demand therapy were included in the analysis. | Posted | Number | number of responses | 4 years | infusions | Participants |
|
|
|
| Secondary | Number of Participants With Less-Than-Expected Therapeutic Effect (LETE) for On-Demand Therapy | Less than expected therapeutic effect was defined as a 'no response' rating after each of two successive infusions less than or equl to (≤) 24 hours of on-demand therapy. | Data were not analyzed as no participants experienced rating of 'no response'. | Posted | 4 years |
|
|
| Secondary | Average Infusion Dose Per Bleeding for On-Demand Therapy (All Participants) | All enrolled participants; only participants who received on-demand therapy were included in the analysis. | Posted | Mean | Standard Deviation | IU | 4 years |
|
|
|
| Secondary | Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants <18 Years of Age | All enrolled participants; only participants <18 years who received on-demand therapy were included in the analysis. | Posted | Median | Full Range | IU | 4 years |
|
|
|
| Secondary | Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants ≥18 Years of Age | All enrolled participants; only participants ≥18 years who received on-demand therapy were included in the analysis. | Posted | Mean | Standard Deviation | IU | 4 years |
|
|
|
| Secondary | Percentage of Participants Experiencing Hemorrhages During Prophylaxis | All enrolled participants; n (number) equals (=) number of participants with nonmissing values | Posted | Number | percentage of participants | 4 years |
|
|
|
| Secondary | Annualized Bleeding Rates During Prophylaxis | Annualized bleeding rate defined as total number of breakthrough bleeds within 48 hours (for prophylaxis purpose) divided by (/) [(total period of date of bleeding)/365.25)] | Data were not analyzed as information on breakthrough bleeds within 48 hours was not collected. | Posted | 4 years |
|
|
| Secondary | Number of Participants With LETE Bleeds Within 48 Hours of a Preventive/Prophylaxis Dose of Xyntha | Less than expected therapeutic effect for prophylaxis therapy defined as breakthrough (spontaneous/non-traumatic) bleed wtihin 48 hours of prophylaxis infusion. | Data were not analyzed as information on breakthrough bleeds within 48 hours was not collected. | Posted | 4 years |
|
|
| Secondary | Average Infusion Dose During Prophylaxis (All Participants) | All enrolled participants; only participants with nonmissing data were included in the analysis. | Posted | Mean | Standard Deviation | IU | 4 years |
|
|
|
| Secondary | Average Infusion Dose During Prophylaxis in Participants <18 Years of Age | All enrolled participants; only participants <18 years were included in the analysis. | Posted | Mean | Standard Deviation | IU | 4 years |
|
|
|
| Secondary | Average Infusion Dose During Prophylaxis in Participants ≥18 Years of Age | All enrolled participants; only participants ≥18 years with nonmissing data were included in the analysis. | Posted | Mean | Standard Deviation | IU | 4 years |
|
|
|
| Secondary | Total Factor Consumption for On-Demand Therapy and During Prophylaxis (All Participants) | All enrolled participants; participants were excluded from the analysis if total number of infusions for prophylaxis was unknown. | Posted | Mean | Standard Deviation | IU | 4 years |
|
|
|
| Secondary | Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants <18 Years of Age | All enrolled participants; only participants <18 years were included in the analysis and participants were excluded from the analysis if total number of infusions for prophylaxis was unknown. | Posted | Median | Full Range | IU | 4 years |
|
|
|
| Secondary | Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants ≥18 Years of Age | All enrolled participants; only participants ≥18 years were included in the analysis; participants were excluded from the analysis if total number of infusions for prophylaxis was unknown. | Posted | Mean | Standard Deviation | IU | 4 years |
|
|
|
| 0 |
| 42 |
| 10 |
| 42 |
| Dyspepsia | Gastrointestinal disorders | WHOART v092 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | WHOART v092 | Non-systematic Assessment |
|
| Irritable bowel syndrome | Gastrointestinal disorders | WHOART v092 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | WHOART v092 | Non-systematic Assessment |
|
| Haemarthrosis | Musculoskeletal and connective tissue disorders | WHOART v092 | Non-systematic Assessment |
|
| Ligament disorder | Musculoskeletal and connective tissue disorders | WHOART v092 | Non-systematic Assessment |
|
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | WHOART v092 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | WHOART v092 | Non-systematic Assessment |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | WHOART v092 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | WHOART v092 | Non-systematic Assessment |
|
| Dermatitis fungal | Skin and subcutaneous tissue disorders | WHOART v092 | Non-systematic Assessment |
|
| Renal calculus | Renal and urinary disorders | WHOART v092 | Non-systematic Assessment |
|
| Xerophthalmia | Eye disorders | WHOART v092 | Non-systematic Assessment |
|
Not provided
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| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Title | Measurements |
|---|
|
| No response |
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| Title | Measurements |
|---|
|
| No response |
|
| Title | Measurements |
|---|
|
| No response |
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|