Trial Outcomes & Findings for Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery (NCT NCT02267226)

Last Updated: 2021-01-15

Results Overview

The first bleeding episode covers the time period from the first Octafibrin infusion until 24 hours (i.e., 1 day) after the last infusion. The investigator's overall clinical assessment of haemostatic efficacy for bleeding was based on a 4 point haemostatic efficacy scale. The final efficacy assessment of each patient was adjudicated by the Independent Data Monitoring \& Endpoint Adjudication Committee (IDMEAC).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

25 participants

Primary outcome timeframe

24 hours after last infusion for each bleeding episode

Results posted on

2021-01-15

Participant Flow

Participant milestones

Participant milestones
Measure	Octafibrin Thirty-three patients were screened and 25 patients received at least one administration of Octafibrin for treatment of bleeding or as surgical prophylaxis. Eight patients received Octafibrin for both bleeding and a surgical procedure. One patient was treated for a surgical procedure only. Octafibrin was individually dosed to achieve a recommended target plasma fibrinogen level of 100 mg/dL for minor bleeds/surgery or 150 mg/dL for major bleeds/surgery
Overall Study STARTED	25
Overall Study SAFETY Population	25
Overall Study FAS-Bleeding Population	24
Overall Study Surgical Prophylaxis Population	9
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SAFETY Population n=25 Participants All patients who received at least one Octafibrin administration during the study.
Age, Categorical <=18 years	6 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	29.04 years STANDARD_DEVIATION 12.95 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours after last infusion for each bleeding episode

Outcome measures

Outcome measures
Measure	Investigator Assessment n=24 Participants Efficacy as assessed by the investigator	IDMEAC Assessment n=24 Participants Efficacy as assessed by the IDMEAC	Day 1 Post-infusion 3 h FAS-Bleeding population, day 1 post-infusion 3h	1 Day After Last Infusion FAS-Bleeding population 1 day after last infusion
Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in Treating the First Documented Bleeding Episode of Each Patient. Excellent	19 Participants	23 Participants	—	—
Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in Treating the First Documented Bleeding Episode of Each Patient. Good	5 Participants	1 Participants	—	—
Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in Treating the First Documented Bleeding Episode of Each Patient. Moderate	0 Participants	0 Participants	—	—
Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in Treating the First Documented Bleeding Episode of Each Patient. None	0 Participants	0 Participants	—	—
Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in Treating the First Documented Bleeding Episode of Each Patient. Missing	0 Participants	0 Participants	—	—
Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in Treating the First Documented Bleeding Episode of Each Patient. Overall treatment success	24 Participants	24 Participants	—	—

SECONDARY outcome

Timeframe: Before first infusion and 1 hour after end of first and last infusion of each documented bleeding episode

MCF (mm) was determined using ROTEM and was used as a surrogate marker for haemostatic efficacy. ROTEM is a method for the continuous measurement of clot formation and clot firmness. It utilises a mechanical detection system which is based on the ability of the blood or plasma clot to form a mechanical coupling over a distance of 1 mm.

Outcome measures

Outcome measures
Measure	Investigator Assessment n=86 Bleeding Episodes (BEs) Efficacy as assessed by the investigator	IDMEAC Assessment Efficacy as assessed by the IDMEAC	Day 1 Post-infusion 3 h FAS-Bleeding population, day 1 post-infusion 3h	1 Day After Last Infusion FAS-Bleeding population 1 day after last infusion
Maximum Clot Firmness (MCF) After Fibrinogen Infusion in Each Documented Bleeding Episode (BE), Measured in Frozen Plasma in a Central Laboratory.	5.79 mm Standard Deviation 2.53	—	—	—

SECONDARY outcome

Timeframe: Before (pre-infusion), 1 hour and 3 hours after the end of each subsequent infusion as well as at the time of the overall clinical assessment of haemostatic efficacy (i.e., 24 hours after the last infusion of each documented bleeding episode)

Fibrinogen plasma level was assessed using the Clauss fibrinogen assay

Outcome measures

Outcome measures
Measure	Investigator Assessment n=88 BEs Efficacy as assessed by the investigator	IDMEAC Assessment n=89 BEs Efficacy as assessed by the IDMEAC	Day 1 Post-infusion 3 h n=82 BEs FAS-Bleeding population, day 1 post-infusion 3h	1 Day After Last Infusion n=84 BEs FAS-Bleeding population 1 day after last infusion
Fibrinogen Plasma Level	0.13 mg/dL Standard Deviation 1.17	109.01 mg/dL Standard Deviation 24.38	104.46 mg/dL Standard Deviation 21.51	70.77 mg/dL Standard Deviation 20.59

SECONDARY outcome

Timeframe: Pre-infusion and 1 and 3 hours post-infusion

Incremental IVR (response): calculated as the maximum increase in plasma fibrinogen (i.e., Clauss data) between pre-infusion and 1 and 3 hours post-infusion, divided by the exact dose of Octafibrin.

Outcome measures

Outcome measures
Measure	Investigator Assessment n=88 BEs Efficacy as assessed by the investigator	IDMEAC Assessment Efficacy as assessed by the IDMEAC	Day 1 Post-infusion 3 h FAS-Bleeding population, day 1 post-infusion 3h	1 Day After Last Infusion FAS-Bleeding population 1 day after last infusion
Response as Indicated by Incremental in Vivo Recovery (IVR)	1.82 mg/dL/(mg/kg) Standard Deviation 0.42	—	—	—

SECONDARY outcome

Timeframe: 24 hours after last infusion for each bleeding episode

The investigator's overall clinical assessment of haemostatic efficacy for bleeding will be based on a 4-point haemostatic efficacy scale. The final efficacy assessment of each patient will be adjudicated by the Independent Data Monitoring \& Endpoint Adjudication Committee (IDMEAC)

Outcome measures

Outcome measures
Measure	Investigator Assessment n=89 BEs Efficacy as assessed by the investigator	IDMEAC Assessment n=89 BEs Efficacy as assessed by the IDMEAC	Day 1 Post-infusion 3 h FAS-Bleeding population, day 1 post-infusion 3h	1 Day After Last Infusion FAS-Bleeding population 1 day after last infusion
Efficacy of Octafibrin for All Bleeding Episodes Collected in the Study Excellent	70 BEs	81 BEs	—	—
Efficacy of Octafibrin for All Bleeding Episodes Collected in the Study Good	16 BEs	7 BEs	—	—
Efficacy of Octafibrin for All Bleeding Episodes Collected in the Study Moderate	1 BEs	1 BEs	—	—
Efficacy of Octafibrin for All Bleeding Episodes Collected in the Study None	0 BEs	0 BEs	—	—
Efficacy of Octafibrin for All Bleeding Episodes Collected in the Study Missing	2 BEs	0 BEs	—	—
Efficacy of Octafibrin for All Bleeding Episodes Collected in the Study Overall treatment success	86 BEs	88 BEs	—	—

SECONDARY outcome

Timeframe: First dose of Octafibrin administered prior to elective surgery to at least 3 post-operative days for minor and 7 post-operative days for major surgeries or last post-operative infusion, whichever comes last

The efficacy of Octafibrin will be assessed at the end of surgery by the surgeon and post-operatively by the haematologist using two 4-point haemostatic efficacy scales. An overall efficacy assessment taking both the intra- and post-operative assessment into account will be adjudicated by the IDMEAC

Outcome measures

Outcome measures
Measure	Investigator Assessment n=12 Surgeries Efficacy as assessed by the investigator	IDMEAC Assessment n=12 Surgeries Efficacy as assessed by the IDMEAC	Day 1 Post-infusion 3 h n=12 Surgeries FAS-Bleeding population, day 1 post-infusion 3h	1 Day After Last Infusion n=12 Surgeries FAS-Bleeding population 1 day after last infusion
Efficacy of Octafibrin in Preventing Bleeding During and After Surgery Excellent	11 Surgeries	11 Surgeries	12 Surgeries	11 Surgeries
Efficacy of Octafibrin in Preventing Bleeding During and After Surgery Good	1 Surgeries	1 Surgeries	0 Surgeries	1 Surgeries
Efficacy of Octafibrin in Preventing Bleeding During and After Surgery Moderate	0 Surgeries	0 Surgeries	0 Surgeries	0 Surgeries
Efficacy of Octafibrin in Preventing Bleeding During and After Surgery None	0 Surgeries	0 Surgeries	0 Surgeries	0 Surgeries
Efficacy of Octafibrin in Preventing Bleeding During and After Surgery Missing	0 Surgeries	0 Surgeries	0 Surgeries	0 Surgeries
Efficacy of Octafibrin in Preventing Bleeding During and After Surgery Overall treatment success	12 Surgeries	12 Surgeries	12 Surgeries	12 Surgeries

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries)

Immunogenicity testing for the presence of anti-fibrinogen antibodies at Day 14 and Day 30 after the administration of Octafibrin for bleeding. An experimental non-standard ELISA was developed for this study for evaluating anti-fibrinogen antibodies. No specific test was performed to discern for neutralizing antibodies. The clinical implications of the assay results are not known.

Outcome measures

Outcome measures
Measure	Investigator Assessment n=24 Participants Efficacy as assessed by the investigator	IDMEAC Assessment n=24 Participants Efficacy as assessed by the IDMEAC	Day 1 Post-infusion 3 h FAS-Bleeding population, day 1 post-infusion 3h	1 Day After Last Infusion FAS-Bleeding population 1 day after last infusion
Analysis of Safety: Immunogenicity Testing for Anti-fibrinogen Antibodies Participants with Anti-fibrinogen Antibodies	4 Participants	6 Participants	—	—
Analysis of Safety: Immunogenicity Testing for Anti-fibrinogen Antibodies Participants without Anti-fibrinogen Antibodies	20 Participants	18 Participants	—	—

Adverse Events

Safety Population

Serious events: 5 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Safety Population n=25 participants at risk All patients who received at least one administration of Octafibrin during the study
Gastrointestinal disorders Upper gastrointestinal haemorrhage	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Injury, poisoning and procedural complications Ligament rupture	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Injury, poisoning and procedural complications Ligament sprain	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Injury, poisoning and procedural complications Patella fracture	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Injury, poisoning and procedural complications Transfusion reaction	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Vascular disorders Accelerated hypertension	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Vascular disorders Thrombosis	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Vascular disorders Peripheral ischaemia	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Infections and infestations Dengue fever	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Infections and infestations Hepatitis C	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Nervous system disorders Haemorrhage intracranial	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Blood and lymphatic system disorders Iron deficiency anaemia	4.0% 1/25 • Number of events 2 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Metabolism and nutrition disorders Hypocalcaemia	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods

Other adverse events

Other adverse events
Measure	Safety Population n=25 participants at risk All patients who received at least one administration of Octafibrin during the study
Gastrointestinal disorders Gingival bleeding	8.0% 2/25 • Number of events 8 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Gastrointestinal disorders Vomiting	8.0% 2/25 • Number of events 4 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Gastrointestinal disorders Abdominal pain upper	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Gastrointestinal disorders Constipation	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Gastrointestinal disorders Gastritis	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Gastrointestinal disorders Lip haemorrhage	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Gastrointestinal disorders Rectal haemorrhage	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Gastrointestinal disorders Toothache	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Injury, poisoning and procedural complications Limb injury	12.0% 3/25 • Number of events 3 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Injury, poisoning and procedural complications Procedural pain	4.0% 1/25 • Number of events 2 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Injury, poisoning and procedural complications Arthropod sting	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Injury, poisoning and procedural complications Contusion	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Injury, poisoning and procedural complications Epicondylitis	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Injury, poisoning and procedural complications Incision site pain	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Injury, poisoning and procedural complications Skin wound	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Injury, poisoning and procedural complications Traumatic haemorrhage	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Vascular disorders Haemorrhage	4.0% 1/25 • Number of events 7 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Vascular disorders Hypertension	8.0% 2/25 • Number of events 2 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Vascular disorders Haematoma	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Infections and infestations Brucellosis	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Infections and infestations Pharyngitis	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Infections and infestations Purulent discharge	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Infections and infestations Rash pustular	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Infections and infestations Rhinitis	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Infections and infestations Tonsillitis	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Musculoskeletal and connective tissue disorders Pain in extremity	12.0% 3/25 • Number of events 4 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Musculoskeletal and connective tissue disorders Arthralgia	8.0% 2/25 • Number of events 2 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Musculoskeletal and connective tissue disorders Groin pain	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Musculoskeletal and connective tissue disorders Muscle haemorrhage	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Skin and subcutaneous tissue disorders Ecchymosis	8.0% 2/25 • Number of events 4 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Skin and subcutaneous tissue disorders Drug eruption	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Skin and subcutaneous tissue disorders Skin fissures	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Skin and subcutaneous tissue disorders Skin haemorrhage	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Skin and subcutaneous tissue disorders Skin lesion	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Nervous system disorders Headache	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Nervous system disorders Hypoaesthesia	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Reproductive system and breast disorders Genital lesion	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Reproductive system and breast disorders Menorrhagia	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Reproductive system and breast disorders Pelvic congestion	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Respiratory, thoracic and mediastinal disorders Epistaxis	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
General disorders Asthenia	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
General disorders Pain	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Investigations Transaminases increased	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Psychiatric disorders Depression	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Renal and urinary disorders Dysuria	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Blood and lymphatic system disorders Reactive thrombocytosis	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods
Vascular disorders Phlebitis	4.0% 1/25 • Number of events 1 • Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries). AEs occurring between the start of the first Octafibrin infusion and the end of each 30-day observation and follow-up period and during the surgical follow-up were recorded as treatment-emergent adverse events (TEAEs). Non-TEAEs were all AEs not falling into the follow-up periods

Additional Information

Director of Clinical Operations

Octapharma USA

Phone: 201 604-1149

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place