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

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ClinicalTrials.gov Identifier: NCT01575756
Recruitment Status : Completed
First Posted : April 11, 2012
Results First Posted : November 30, 2016
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Octapharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Congenital Fibrinogen Deficiency
Afibrinogenemia
Interventions Biological: Octafibrin
Biological: Haemocomplettan® P or RiaSTAPTM
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Octafibrin/FIBRYGA® Followed by Haemocomplettan® P/RiaSTAP(TM) Haemocomplettan® P/RiaSTAP(TM) Followed by Octafibrin/FIBRYGA®
Hide Arm/Group Description Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once followed by Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once 45 days later. Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once followed by Octafibrin/FIBRYGA® 70 mg/kg BW intravenously once 45 days later.
Period Title: Treatment Period 1
Started 11 11
Completed 11 11
Not Completed 0 0
Period Title: Treatment Period 2
Started 11 11
Completed 11 11
Not Completed 0 0
Arm/Group Title Full Analysis Set
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
26.0  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
15
  68.2%
Male
7
  31.8%
1.Primary Outcome
Title Ratio of Octafibrin/FIBRYGA® to Haemocomplettan® P/RiaSTAP(TM) for Fibrinogen Activity Normalized Area Under the Curve Unstandardized
Hide Description Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment. The mean ratio of normalized area under the curve was calculated as Octafibrin/FIBRYGA® over Haemocomplettan® P/RiaSTAP(TM)
Time Frame Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pharmacokinetic (PK)-Per Protocol Dataset
Hide Arm/Group Description:
Ratio comparison of participants who received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once, and participants who received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once
Overall Number of Participants Analyzed 21
Mean (90% Confidence Interval)
Unit of Measure: ratio
1.196
(1.117 to 1.281)
2.Primary Outcome
Title Comparison of Maximum Clot Firmness Between Octafibrin/FIBRYGA® and Haemocomplettan® P/RiaSTAP(TM) at 1 hr Post Infusion
Hide Description Thromboelastometry (ROTEM®) was used to measure maximum clot firmness. Thromboelastometry is a method for the continuous measurement of clot formation. Maximum clot firmness is a functional parameter that depends on the activation of coagulation, the platelet and fibrinogen content of the blood sample, and the polymerisation and cross-linking of the fibrin network. In order to obtain comparable results from all study centres, maximum clot firmness data were assessed from frozen citrated plasma samples in a central laboratory. As these samples did not contain platelets that would be found in the whole blood assay, the fibrinogen content primarily defined the maximum clot firmness.
Time Frame 1 hour post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Octafibrin/FIBRYGA® Haemocomplettan® P/RiaSTAP(TM)
Hide Arm/Group Description:
Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
Overall Number of Participants Analyzed 22 22
Mean (95% Confidence Interval)
Unit of Measure: mm
9.68
(8.37 to 10.99)
10.00
(8.07 to 11.93)
3.Secondary Outcome
Title Fibrinogen Activity Normalized Area Under the Curve Unstandardized
Hide Description Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.
Time Frame Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Octafibrin/FIBRYGA® Haemocomplettan® P/RiaSTAP(TM)
Hide Arm/Group Description:
Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: h•kg•g/L/mg
1.62  (0.45) 1.38  (0.47)
4.Secondary Outcome
Title Fibrinogen Activity Normalized Area Under the Curve Standardized
Hide Description Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment. The normalized area under the curve was standardized to a dose of 70 mg/kg.
Time Frame Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Octafibrin/FIBRYGA® Haemocomplettan® P/RiaSTAP(TM)
Hide Arm/Group Description:
Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: g•h/L
113.70  (31.54) 96.39  (32.89)
5.Secondary Outcome
Title Maximum Plasma Concentration Normalized (Cmaxnorm)
Hide Description Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.
Time Frame Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Octafibrin/FIBRYGA® Haemocomplettan® P/RiaSTAP(TM)
Hide Arm/Group Description:
Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: kg•g/L/mg
0.018  (0.005) 0.018  (0.005)
6.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) Unstandardized
Hide Description Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.
Time Frame Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Octafibrin/FIBRYGA® Haemocomplettan® P/RiaSTAP(TM)
Hide Arm/Group Description:
Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: g/L
1.390  (0.369) 1.265  (0.309)
7.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) Standardized
Hide Description Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment. The maximum plasma concentration was standardized to a dose of 70 mg/kg.
Time Frame Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Octafibrin/FIBRYGA® Haemocomplettan® P/RiaSTAP(TM)
Hide Arm/Group Description:
Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: g•h/L
1.266  (0.338) 1.271  (0.312)
8.Secondary Outcome
Title Incremental in Vivo Recovery
Hide Description Incremental in vivo recovery was calculated as the maximum increase in plasma fibrinogen (fibrinogen activity assay data) within 4 hours post-treatment as compared with pre-treatment (expressed as an absolute mg/dL concentration in plasma), divided by the exact dose of Octafibrin/FIBRYGA® or Haemocomplettan® P/RiaSTAP(TM) (expressed as mg/kg dosed).
Time Frame Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Octafibrin/FIBRYGA® Haemocomplettan® P/RiaSTAP(TM)
Hide Arm/Group Description:
Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: mg/dL/(mg/kg)
1.787  (0.458) 1.770  (0.442)
9.Secondary Outcome
Title Classical in Vivo Recovery
Hide Description Classical in vivo recovery was calculated as: 100 x the maximum increase in plasma fibrinogen (fibrinogen activity assay data) within 4 hours post-treatment as compared with pre-treatment (expressed as an absolute mg/dL concentration in plasma) x the plasma volume (mL), divided by the exact dose of Octafibrin/FIBRYGA® or Haemocomplettan® P/RiaSTAP(TM) (expressed as mg).
Time Frame Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Octafibrin/FIBRYGA® Haemocomplettan® P/RiaSTAP(TM)
Hide Arm/Group Description:
Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: percentage
64.397  (11.519) 66.046  (11.635)
10.Secondary Outcome
Title Time to Reach Maximum Plasma Concentration (Tmax)
Hide Description Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.
Time Frame Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Octafibrin/FIBRYGA® Haemocomplettan® P/RiaSTAP(TM)
Hide Arm/Group Description:
Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: h
2.148  (1.475) 1.417  (2.054)
11.Secondary Outcome
Title Terminal Half-life (t½)
Hide Description Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.
Time Frame Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Octafibrin/FIBRYGA® Haemocomplettan® P/RiaSTAP(TM)
Hide Arm/Group Description:
Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: h
75.940  (23.831) 69.378  (16.006)
12.Secondary Outcome
Title Mean Residence Time (MRT)
Hide Description Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.
Time Frame Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Octafibrin/FIBRYGA® Haemocomplettan® P/RiaSTAP(TM)
Hide Arm/Group Description:
Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: h
106.272  (30.927) 98.977  (20.812)
13.Secondary Outcome
Title Clearance
Hide Description Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.
Time Frame Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Octafibrin/FIBRYGA® Haemocomplettan® P/RiaSTAP(TM)
Hide Arm/Group Description:
Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: mL/h/kg
0.665  (0.197) 0.804  (0.255)
14.Secondary Outcome
Title Volume of Distribution at Steady State (Vss)
Hide Description Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.
Time Frame Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Octafibrin/FIBRYGA® Haemocomplettan® P/RiaSTAP(TM)
Hide Arm/Group Description:
Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: mL/kg
70.158  (29.860) 76.631  (19.579)
Time Frame [Not Specified]
Adverse Event Reporting Description Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
 
Arm/Group Title Octafibrin/FIBRYGA® Haemocomplettan® P/RiaSTAP(TM)
Hide Arm/Group Description Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once. Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
All-Cause Mortality
Octafibrin/FIBRYGA® Haemocomplettan® P/RiaSTAP(TM)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Octafibrin/FIBRYGA® Haemocomplettan® P/RiaSTAP(TM)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/22 (4.55%)   0/22 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/22 (4.55%)  0/22 (0.00%) 
Reproductive system and breast disorders     
Vaginal haemorrhage  1  1/22 (4.55%)  0/22 (0.00%) 
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Octafibrin/FIBRYGA® Haemocomplettan® P/RiaSTAP(TM)
Affected / at Risk (%) Affected / at Risk (%)
Total   11/22 (50.00%)   11/22 (50.00%) 
Ear and labyrinth disorders     
Vertigo  1  0/22 (0.00%)  1/22 (4.55%) 
Gastrointestinal disorders     
Abdominal pain upper  1  0/22 (0.00%)  1/22 (4.55%) 
Diarrhoea  1  1/22 (4.55%)  1/22 (4.55%) 
Dyspepsia  1  1/22 (4.55%)  0/22 (0.00%) 
Food poisoning  1  0/22 (0.00%)  1/22 (4.55%) 
Gingival bleeding  1  1/22 (4.55%)  0/22 (0.00%) 
Haematemesis  1  0/22 (0.00%)  1/22 (4.55%) 
Nausea  1  0/22 (0.00%)  1/22 (4.55%) 
General disorders     
Asthenia  1  1/22 (4.55%)  0/22 (0.00%) 
Fatigue  1  1/22 (4.55%)  0/22 (0.00%) 
Pain  1  0/22 (0.00%)  1/22 (4.55%) 
Pyrexia  1  2/22 (9.09%)  3/22 (13.64%) 
Immune system disorders     
Mild allergic skin reaction  1  1/22 (4.55%)  0/22 (0.00%) 
Infections and infestations     
Nasopharyngitis  1  1/22 (4.55%)  2/22 (9.09%) 
Upper respiratory tract infection  1  0/22 (0.00%)  1/22 (4.55%) 
Urinary tract infection  1  1/22 (4.55%)  0/22 (0.00%) 
Injury, poisoning and procedural complications     
Animal bite  1  1/22 (4.55%)  0/22 (0.00%) 
Contusion  1  1/22 (4.55%)  0/22 (0.00%) 
Fall  1  1/22 (4.55%)  0/22 (0.00%) 
Post procedural haemorrhage  1  0/22 (0.00%)  1/22 (4.55%) 
Traumatic haematoma  1  0/22 (0.00%)  1/22 (4.55%) 
Investigations     
Alanine aminotransferase increased  1  0/22 (0.00%)  1/22 (4.55%) 
Aspartate aminotransferase increased  1  0/22 (0.00%)  1/22 (4.55%) 
Haemoglobin decreased  1  1/22 (4.55%)  1/22 (4.55%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/22 (4.55%)  0/22 (0.00%) 
Iron deficiency  1  1/22 (4.55%)  0/22 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/22 (9.09%)  0/22 (0.00%) 
Back pain  1  0/22 (0.00%)  1/22 (4.55%) 
Flank pain  1  0/22 (0.00%)  1/22 (4.55%) 
Haemarthrosis  1  1/22 (4.55%)  0/22 (0.00%) 
Joint swelling  1  1/22 (4.55%)  0/22 (0.00%) 
Myalgia  1  0/22 (0.00%)  1/22 (4.55%) 
Pain in extremity  1  1/22 (4.55%)  2/22 (9.09%) 
Nervous system disorders     
Dizziness  1  0/22 (0.00%)  1/22 (4.55%) 
Headache  1  0/22 (0.00%)  2/22 (9.09%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/22 (0.00%)  1/22 (4.55%) 
Vascular disorders     
Haematoma  1  1/22 (4.55%)  1/22 (4.55%) 
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Octapharma agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Octapharma supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial. Octapharma also reserves the right to review data prior to publishing and provide comments/changes within a certain time period.
Results Point of Contact
Name/Title: Director of Clinical Operations
Organization: Octapharma USA
Phone: 201 604-1149
Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01575756     History of Changes
Other Study ID Numbers: FORMA-01
First Submitted: April 9, 2012
First Posted: April 11, 2012
Results First Submitted: October 5, 2016
Results First Posted: November 30, 2016
Last Update Posted: March 9, 2018