| Primary | Number of Treatment Emergent (Serious and Non-serious) Adverse Events | An adverse event was described as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. Treatment emergent adverse events (serious and non-serious), defined as adverse events occurring from first trial product administration to the end of the subject's participation in the trial. | The safety analysis set included all subjects who received at least one dose of the trial product. | Posted | | Number | | number of events | | Week 0 to end of trial visit (week 173) for a minimum period of 52 weeks. | | | | ID | Title | Description |
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| OG000 | rFXIII 35 IU/kg | Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations. |
| | | Title | Denominators | Categories |
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| All adverse events | | | | Serious adverse events | | | | Non-serious adverse events | | |
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| Secondary | Percentage of Subjects With Development of Anti-rFXIII Antibodies, Including Inhibitors. | All subjects who received rFXIII were monitored for the frequency of development of anti-rFXIII antibodies. Samples passed through 2 tiers of ELISA testing: an initial screen with a specific cut-off point (including ~5% false positives) and a second confirmatory assay for samples yielding a result above the screening cut-off point. If samples were confirmed as antibody positive in the confirmation assay, an inhibitor assay was also carried out to detect functional inhibitors. | The SAS included all subjects who received at least one dose of the trial product. There were no antibodies against rFXIII detected in any patient during the trial. | Posted | | Number | | percentage of subjects | | Week 0 to end of trial visit (week 173). | | | | ID | Title | Description |
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| OG000 | rFXIII 35 IU/kg | Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations. |
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| Secondary | Clinical Laboratory Assessments: Biochemistry: Creatinine | Clinical laboratory assessments for creatinine at week 24 to end of trial visit. | The safety analysis set included all subjects who received at least one dose of the trial product. | Posted | | Mean | Standard Deviation | mmol/L | | Every 6th month, from week 24 to end of trial visit (week 173). | | | | ID | Title | Description |
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| OG000 | rFXIII 35 IU/kg | Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations. |
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| Secondary | Clinical Laboratory Assessments: Biochemistry: Urea | Clinical laboratory assessments for urea at week 24 to end ot trial visit. | The safety analysis set included all subjects who received at least one dose of the trial product. | Posted | | Mean | Standard Deviation | mmol/L | | Every 6th month, week 24 to end of trial visit (week 173). | | | | ID | Title | Description |
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| OG000 | rFXIII 35 IU/kg | Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations. |
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| Secondary | Clinical Laboratory Assessments: Biochemistry: Alanine Aminotransferase (ALAT) | Clinical laboratory assessments for ALAT at week 24 to end of trial visit. | The safety analysis set included all subjects who received at least one dose of the trial product. | Posted | | Mean | Standard Deviation | IU/L | | Every 6th month, from week 24 to end of trial visit (week 173). | | | | ID | Title | Description |
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| OG000 | rFXIII 35 IU/kg | Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations. |
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| Secondary | Clinical Laboratory Assessments: Biochemistry: Aspartate Aminotransferase (ASAT) | Clinical laboratory assessments for ASAT at week 24 to end of trial visit. | The safety analysis set included all subjects who received at least one dose of the trial product. | Posted | | Mean | Standard Deviation | IU/L | | Every 6th month, from week 24 to end of trial visit (week 173). | | | | ID | Title | Description |
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| OG000 | rFXIII 35 IU/kg | Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations. |
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| Secondary | Clinical Laboratory Assessments: Haematology: Haemoglobin | Clinical values for haemoglobin collected from week 0 to end of trial visit. | The safety analysis set included all subjects who received at least one dose of the trial product. | Posted | | Mean | Standard Deviation | mmol/L | | Every 6th month, from week 0 to end of trial visit (week 173). | | | | ID | Title | Description |
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| OG000 | rFXIII 35 IU/kg | Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations. |
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| Secondary | Clinical Laboratory Assessments: Haematology: Leucocytes | Clinical laboratory values for leucocytes collected from week 0 to end of trial visit. | The safety analysis set included all subjects who received at least one dose of the trial product. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Every 6th month, from week 0 to end of trial visit (week 173). | | | | ID | Title | Description |
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| OG000 | rFXIII 35 IU/kg | Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations. |
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| Secondary | Clinical Laboratory Assessments: Haematology: Thrombocytes | Clinical laboratory values for thrombocytes collected from week 0 to end of trial visit. | The safety analysis set included all subjects who received at least one dose of the trial product. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Every 6th month, from week 0 to end of trial visit (week 173). | | | | ID | Title | Description |
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| OG000 | rFXIII 35 IU/kg | Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations. |
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| Secondary | Clinical Laboratory Assessments: Haematology: Erythrocytes | Clinical laboratory values for erythrocytes collected from week 0 to end of trial visit. | The safety analysis set included all subjects who received at least one dose of the trial product. | Posted | | Mean | Standard Deviation | 10^12 cells/L | | Every 6th month, from week 0 to end of trial visit (week 173). | | | | ID | Title | Description |
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| OG000 | rFXIII 35 IU/kg | Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations. |
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| Secondary | Clinical Laboratory Assessments: Haematology: Haematocrit | Clinical laboratory values for haematocrit collected from week 0 to end of trial visit. | The safety analysis set included all subjects who received at least one dose of the trial product. | Posted | | Mean | Standard Deviation | percentage of red blood cells | | Every 6th month, from week 0 to end of trial visit (week 173). | | | | ID | Title | Description |
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| OG000 | rFXIII 35 IU/kg | Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations. |
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| Secondary | Physical Examinations | Number of subjects in percentage with changes in values of physical examinations from week 0 to end of trial visit were collected. | The safety analysis set included all subjects who received at least one dose of the trial product. Two abnormal physical examination findings related to skin and musculo-skeletal system were assessed as clinically significant by the investigator during the trial. | Posted | | Number | | percentage of subjects | | Week 0 to end of trial visit (week 173). | | | | ID | Title | Description |
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| OG000 | rFXIII 35 IU/kg | Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations. |
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| Secondary | Vital Signs: Systolic BP (Blood Pressure) | Values collected for systolic BP from week 0 to end of trial visit. | The safety analysis set included all subjects who received at least one dose of the trial product. | Posted | | Mean | Standard Deviation | mmHg | | Week 0 to end of trial visit (week 173). | | | | ID | Title | Description |
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| OG000 | rFXIII 35 IU/kg | Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations. |
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| Secondary | Vital Signs: Diastolic BP (Blood Pressure) | Values collected for diastolic BP from week 0 to end of trial visit. | The safety analysis set one dose of the trial product. | Posted | | Mean | Standard Deviation | mmHg | | Week 0 to end of trial visit (week 173). | | | | ID | Title | Description |
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| OG000 | rFXIII 35 IU/kg | Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations. |
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| Secondary | Vital Signs: Pulse | Values collected for pulse from week 0 to end of trial visit. | The safety analysis included all subjects who received at least one dose of the trial product. | Posted | | Mean | Standard Deviation | beats/minute | | Week 0 to end of trial visit (week 173). | | | | ID | Title | Description |
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| OG000 | rFXIII 35 IU/kg | Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations. |
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| Secondary | Rate (Number Per Subject Year) of All Bleeding Episodes Requiring Treatment With a FXIII Containing Product Other Than Recombinant Factor XIII. | The rate (number per subject year) of all spontaneous, traumatic and intracranial bleeding episodes requiring treatment with FXIII-containing products during the rFXIII treatment period was assessed for treatment period. | There were no bleeding episodes requiring treatment with a haemostatic agent (rFXIII) during the trial, which included subjects from full analysis set who received at least one dose of the trial product. | Posted | | | | | | Weeks 0 to end of trial visit (week 173). | | | | ID | Title | Description |
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| OG000 | rFXIII 35 IU/kg | Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations. |
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