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Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap
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Trial · NCT01575756

Results by group27

Each measurement the trial posted, group by group, in the words and numbers it posted.

1 to 20 of 27

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OutcomeGroupCategoryValueSpreadUnits
Ratio of Octafibrin/FIBRYGA® to Haemocomplettan® P/RiaSTAP(TM) for Fibrinogen Activity Normalized Area Under the Curve UnstandardizedPharmacokinetic (PK)-Per Protocol Dataset1.19690% Confidence Interval 1.117 to 1.281ratio
Comparison of Maximum Clot Firmness Between Octafibrin/FIBRYGA® and Haemocomplettan® P/RiaSTAP(TM) at 1 hr Post InfusionOctafibrin/FIBRYGA®9.6895% Confidence Interval 8.37 to 10.99mm
Comparison of Maximum Clot Firmness Between Octafibrin/FIBRYGA® and Haemocomplettan® P/RiaSTAP(TM) at 1 hr Post InfusionHaemocomplettan® P/RiaSTAP(TM)10.0095% Confidence Interval 8.07 to 11.93mm
Fibrinogen Activity Normalized Area Under the Curve UnstandardizedOctafibrin/FIBRYGA®1.62Standard Deviation 0.45h•kg•g/L/mg
Fibrinogen Activity Normalized Area Under the Curve UnstandardizedHaemocomplettan® P/RiaSTAP(TM)1.38Standard Deviation 0.47h•kg•g/L/mg
Fibrinogen Activity Normalized Area Under the Curve StandardizedOctafibrin/FIBRYGA®113.70Standard Deviation 31.54g•h/L
Fibrinogen Activity Normalized Area Under the Curve StandardizedHaemocomplettan® P/RiaSTAP(TM)96.39Standard Deviation 32.89g•h/L
Maximum Plasma Concentration Normalized (Cmaxnorm)Octafibrin/FIBRYGA®0.018Standard Deviation 0.005kg•g/L/mg
Maximum Plasma Concentration Normalized (Cmaxnorm)Haemocomplettan® P/RiaSTAP(TM)0.018Standard Deviation 0.005kg•g/L/mg
Maximum Plasma Concentration (Cmax) UnstandardizedOctafibrin/FIBRYGA®1.390Standard Deviation 0.369g/L
Maximum Plasma Concentration (Cmax) UnstandardizedHaemocomplettan® P/RiaSTAP(TM)1.265Standard Deviation 0.309g/L
Maximum Plasma Concentration (Cmax) StandardizedOctafibrin/FIBRYGA®1.266Standard Deviation 0.338g•h/L
Maximum Plasma Concentration (Cmax) StandardizedHaemocomplettan® P/RiaSTAP(TM)1.271Standard Deviation 0.312g•h/L
Incremental in Vivo RecoveryOctafibrin/FIBRYGA®1.787Standard Deviation 0.458mg/dL/(mg/kg)
Incremental in Vivo RecoveryHaemocomplettan® P/RiaSTAP(TM)1.770Standard Deviation 0.442mg/dL/(mg/kg)
Classical in Vivo RecoveryOctafibrin/FIBRYGA®64.397Standard Deviation 11.519percentage
Classical in Vivo RecoveryHaemocomplettan® P/RiaSTAP(TM)66.046Standard Deviation 11.635percentage
Time to Reach Maximum Plasma Concentration (Tmax)Octafibrin/FIBRYGA®2.148Standard Deviation 1.475h
Time to Reach Maximum Plasma Concentration (Tmax)Haemocomplettan® P/RiaSTAP(TM)1.417Standard Deviation 2.054h
Terminal Half-life (t½)Octafibrin/FIBRYGA®75.940Standard Deviation 23.831h

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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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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