Trial Outcomes & Findings for A Trial to Investigate the Relative Efficacy, Safety, and Tolerability of Octaplas LG Versus Octaplas SD (NCT NCT01063595)

Last Updated: 2014-05-20

Results Overview

Recovery was defined as the maximum percentage change of the coagulation factor value measured 5 minutes after the end of plasmapheresis to the coagulation factor value measured at 15 minutes or 2 hours after the end of study drug administration. The coagulation parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

63 participants

Primary outcome timeframe

From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration

Results posted on

2014-05-20

Participant Flow

Participant milestones

Participant milestones
Measure	Octaplas SD First, Then Octaplas LG Participants received 1200 mL of Octaplas SD intravenously once. At least 4 weeks later, participants received 1200 mL of Octaplas LG intravenously once.	Octaplas LG First, Then Octaplas SD Participants received 1200 mL of Octaplas LG intravenously once. At least 4 weeks later, participants received 1200 mL of Octaplas SD intravenously once.
Enrolled in Study and Randomized STARTED	32	31
Enrolled in Study and Randomized Received Treatment	31	29
Enrolled in Study and Randomized COMPLETED	31	29
Enrolled in Study and Randomized NOT COMPLETED	1	2
First Intervention STARTED	31	29
First Intervention COMPLETED	29	24
First Intervention NOT COMPLETED	2	5
Second Intervention STARTED	29	24
Second Intervention COMPLETED	29	24
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Octaplas SD First, Then Octaplas LG Participants received 1200 mL of Octaplas SD intravenously once. At least 4 weeks later, participants received 1200 mL of Octaplas LG intravenously once.	Octaplas LG First, Then Octaplas SD Participants received 1200 mL of Octaplas LG intravenously once. At least 4 weeks later, participants received 1200 mL of Octaplas SD intravenously once.
Enrolled in Study and Randomized Reason not Specified	1	0
Enrolled in Study and Randomized Adverse Event	0	1
Enrolled in Study and Randomized Withdrawn by the Investigator	0	1
First Intervention Adverse Event	1	4
First Intervention Withdrawal by Subject	1	0
First Intervention Reason not Specified	0	1

Baseline Characteristics

A Trial to Investigate the Relative Efficacy, Safety, and Tolerability of Octaplas LG Versus Octaplas SD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=60 Participants Participants received 1200 mL of Octaplas LG intravenously once and 1200 mL of Octaplas SD intravenously once in a crossover design.
Age, Continuous	32.6 Years STANDARD_DEVIATION 9.11 • n=99 Participants
Sex: Female, Male Female	25 Participants n=99 Participants
Sex: Female, Male Male	35 Participants n=99 Participants

PRIMARY outcome

Timeframe: From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration

Population: Per protocol population: All participants who had evaluable efficacy measurements in both of the treatment periods.

Outcome measures

Outcome measures
Measure	Octaplas LG n=43 Participants Participants received 1200 mL of Octaplas LG intravenously once.	Octaplas SD n=43 Participants Participants received 1200 mL of Octaplas SD intravenously once.
Recovery of the Coagulation Factors I, II, V, VII, VIII, IX, X, and XI Factor V	6.31 Percentage change Standard Deviation 9.35	6.91 Percentage change Standard Deviation 10.09
Recovery of the Coagulation Factors I, II, V, VII, VIII, IX, X, and XI Factor VII	8.48 Percentage change Standard Deviation 11.03	9.28 Percentage change Standard Deviation 14.53
Recovery of the Coagulation Factors I, II, V, VII, VIII, IX, X, and XI Factor VIII	1.50 Percentage change Standard Deviation 9.38	5.21 Percentage change Standard Deviation 9.93
Recovery of the Coagulation Factors I, II, V, VII, VIII, IX, X, and XI Factor IX	8.86 Percentage change Standard Deviation 9.11	11.08 Percentage change Standard Deviation 7.74
Recovery of the Coagulation Factors I, II, V, VII, VIII, IX, X, and XI Factor I	8.11 Percentage change Standard Deviation 8.93	9.12 Percentage change Standard Deviation 8.75
Recovery of the Coagulation Factors I, II, V, VII, VIII, IX, X, and XI Factor II	7.08 Percentage change Standard Deviation 6.46	6.68 Percentage change Standard Deviation 7.35
Recovery of the Coagulation Factors I, II, V, VII, VIII, IX, X, and XI Factor X	7.90 Percentage change Standard Deviation 8.96	9.97 Percentage change Standard Deviation 12.37
Recovery of the Coagulation Factors I, II, V, VII, VIII, IX, X, and XI Factor XI	6.53 Percentage change Standard Deviation 6.32	8.24 Percentage change Standard Deviation 7.54

PRIMARY outcome

Timeframe: From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration

Population: Per protocol population: All participants who had evaluable efficacy measurements in both of the treatment periods.

Recovery was defined as the maximum (minimum for activated partial thromboplastin time) percentage change of the haemostatic parameter value measured 5 minutes after the end of plasmapheresis to the haemostatic parameter value measured at 15 minutes or 2 hours after the end of study drug administration. The haemostatic parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration.

Outcome measures

Outcome measures
Measure	Octaplas LG n=43 Participants Participants received 1200 mL of Octaplas LG intravenously once.	Octaplas SD n=43 Participants Participants received 1200 mL of Octaplas SD intravenously once.
Recovery of the Haemostatic Parameters Prothrombin Time, Activated Partial Thromboplastin Time, and Protein C Prothrombin time	1.36 Percentage change Standard Deviation 4.71	2.85 Percentage change Standard Deviation 6.18
Recovery of the Haemostatic Parameters Prothrombin Time, Activated Partial Thromboplastin Time, and Protein C Activated partial thromboplastin time	-4.60 Percentage change Standard Deviation 3.71	-5.73 Percentage change Standard Deviation 4.39
Recovery of the Haemostatic Parameters Prothrombin Time, Activated Partial Thromboplastin Time, and Protein C Protein C	9.49 Percentage change Standard Deviation 8.44	9.75 Percentage change Standard Deviation 6.97

SECONDARY outcome

Timeframe: From 30 minutes before plasmapheresis up to 24 hours after the end of plasmapheresis

Population: Per protocol population: All participants who had evaluable efficacy measurements in both of the treatment periods.

Values of plasmin inhibitor were measured by validated assays from blood samples obtained 30 minutes before plasmapheresis, 5 minutes after the end of plasmapheresis, 15 minutes and 2 hours after the end of study drug administration, and 24 hours and 7 days after initiation of plasmapheresis. The concentration of plasmin inhibitor is reported as the percentage of plasmin inhibition. A higher concentration of plasmin inhibitor results in a higher percentage of plasmin inhibition.

Outcome measures

Outcome measures
Measure	Octaplas LG n=43 Participants Participants received 1200 mL of Octaplas LG intravenously once.	Octaplas SD n=43 Participants Participants received 1200 mL of Octaplas SD intravenously once.
Concentration of Plasmin Inhibitor Pre-plasmapheresis 30 minutes	90.51 Percentage inhibition Standard Deviation 9.93	91.53 Percentage inhibition Standard Deviation 9.12
Concentration of Plasmin Inhibitor Post-plasmapheresis 5 minutes	85.72 Percentage inhibition Standard Deviation 9.34	85.67 Percentage inhibition Standard Deviation 10.08
Concentration of Plasmin Inhibitor Post-transfusion 15 minutes	79.81 Percentage inhibition Standard Deviation 8.15	74.93 Percentage inhibition Standard Deviation 8.72
Concentration of Plasmin Inhibitor Post-transfusion 2 hours	79.21 Percentage inhibition Standard Deviation 8.45	75.23 Percentage inhibition Standard Deviation 9.11
Concentration of Plasmin Inhibitor Post-plasmapheresis 24 hours	88.35 Percentage inhibition Standard Deviation 9.41	85.40 Percentage inhibition Standard Deviation 8.93
Concentration of Plasmin Inhibitor Post-plasmapheresis 7 days	90.95 Percentage inhibition Standard Deviation 9.79	91.65 Percentage inhibition Standard Deviation 9.88

Adverse Events

Octaplas LG

Serious events: 1 serious events

Other events: 34 other events

Deaths: 0 deaths

Octaplas SD

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Octaplas LG n=60 participants at risk Participants received 1200 mL of Octaplas LG intravenously once.	Octaplas SD n=60 participants at risk Participants received 1200 mL of Octaplas SD intravenously once.
Vascular disorders Anaphylactic shock	1.7% 1/60 Safety population: All participants who received at least 1 of the study treatments in any study period.	0.00% 0/60 Safety population: All participants who received at least 1 of the study treatments in any study period.

Other adverse events

Other adverse events
Measure	Octaplas LG n=60 participants at risk Participants received 1200 mL of Octaplas LG intravenously once.	Octaplas SD n=60 participants at risk Participants received 1200 mL of Octaplas SD intravenously once.
Gastrointestinal disorders Nausea	5.0% 3/60 Safety population: All participants who received at least 1 of the study treatments in any study period.	1.7% 1/60 Safety population: All participants who received at least 1 of the study treatments in any study period.
Immune system disorders Urticaria	16.7% 10/60 Safety population: All participants who received at least 1 of the study treatments in any study period.	15.0% 9/60 Safety population: All participants who received at least 1 of the study treatments in any study period.
Nervous system disorders Headache	13.3% 8/60 Safety population: All participants who received at least 1 of the study treatments in any study period.	15.0% 9/60 Safety population: All participants who received at least 1 of the study treatments in any study period.
Nervous system disorders Paraesthesia	5.0% 3/60 Safety population: All participants who received at least 1 of the study treatments in any study period.	3.3% 2/60 Safety population: All participants who received at least 1 of the study treatments in any study period.
Nervous system disorders Paraesthesia oral	15.0% 9/60 Safety population: All participants who received at least 1 of the study treatments in any study period.	10.0% 6/60 Safety population: All participants who received at least 1 of the study treatments in any study period.
Nervous system disorders Vertigo	0.00% 0/60 Safety population: All participants who received at least 1 of the study treatments in any study period.	5.0% 3/60 Safety population: All participants who received at least 1 of the study treatments in any study period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.0% 3/60 Safety population: All participants who received at least 1 of the study treatments in any study period.	3.3% 2/60 Safety population: All participants who received at least 1 of the study treatments in any study period.
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	8.3% 5/60 Safety population: All participants who received at least 1 of the study treatments in any study period.	15.0% 9/60 Safety population: All participants who received at least 1 of the study treatments in any study period.
Skin and subcutaneous tissue disorders Urticaria	3.3% 2/60 Safety population: All participants who received at least 1 of the study treatments in any study period.	5.0% 3/60 Safety population: All participants who received at least 1 of the study treatments in any study period.

Additional Information

Michael Eppolito, Director, Clinical Operations Immunology and ICU Medicine

Octapharma USA

Phone: 201 604-1155

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place