Trial · NCT01575756
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ratio of Octafibrin/FIBRYGA® to Haemocomplettan® P/RiaSTAP(TM) for Fibrinogen Activity Normalized Area Under the Curve Unstandardized | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T. | ratio | MEAN |
| PRIMARY | Comparison of Maximum Clot Firmness Between Octafibrin/FIBRYGA® and Haemocomplettan® P/RiaSTAP(TM) at 1 hr Post Infusion | 1 hour post-treatment | Full analysis set: All randomised participants who received at least 1 infusion of study medication (Octafibrin/FIBRYGA®) and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)) and for whom any post-treatment data were available. | mm | MEAN |
| SECONDARY | Fibrinogen Activity Normalized Area Under the Curve Unstandardized | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T. | h•kg•g/L/mg | MEAN |
| SECONDARY | Fibrinogen Activity Normalized Area Under the Curve Standardized | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses; had any post-T data; did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T. | g•h/L | MEAN |
| SECONDARY | Maximum Plasma Concentration Normalized (Cmaxnorm) | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T. | kg•g/L/mg | MEAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) Unstandardized | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T. | g/L | MEAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) Standardized | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses; had any post-T data; did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T. | g•h/L | MEAN |
| SECONDARY | Incremental in Vivo Recovery | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T. | mg/dL/(mg/kg) | MEAN |
| SECONDARY | Classical in Vivo Recovery | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T. | percentage | MEAN |
| SECONDARY | Time to Reach Maximum Plasma Concentration (Tmax) | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T. | h | MEAN |
| SECONDARY | Terminal Half-life (t½) | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T. | h | MEAN |
| SECONDARY | Mean Residence Time (MRT) | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T. | h | MEAN |
| SECONDARY | Clearance | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T. | mL/h/kg | MEAN |
| SECONDARY | Volume of Distribution at Steady State (Vss) | Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment | Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T. | mL/kg | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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