A comparative, open-label, randomised, cross-over phase I trial in healthy volunteers to investigate the relative efficacy, safety and tolerability of OctaplasLG™ versus Octaplas® SD

ISRCTN	ISRCTN35401703
DOI	https://doi.org/10.1186/ISRCTN35401703
EudraCT/CTIS number	2009-012856-26
Secondary identifying numbers	LAS-203

Submission date: 03/09/2009
Registration date: 04/09/2009
Last edited: 28/10/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Claudia Walasek
Scientific

Oberlaaerstrasse 235
Vienna
1100
Austria

Phone	+43 (0)1 61032 1791
Email	claudia.walasek@octapharma.com

Study information

Study design	Open-label block randomised cross-over phase I study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request patient information material
Scientific title
Study objectives	Comparison of efficacy, safety and tolerability of OctaplasLG™ versus Octaplas® SD plasma in healthy volunteers.
Ethics approval(s)	Local medical ethics committee (ethikkommission der med Uni Wien und des Allg Krankenhauses der Stadt Wien AKH) approved on the 15th July 2009 (ref: 460/2009)
Health condition(s) or problem(s) studied	Safety/efficacy/tolerability of plasma products
Intervention	The treatment day will start with plasmapheresis (600 ml) then transfusion of either OctaplasLG™ or Octaplas® SD will be randomly assigned. Safety, efficacy and tolerability will be assessed by clinical and laboratory parameters (haematology, coagulation factors, haemostatic parameters, chemistry). All these parameters will be collected before and immediately after plasmapheresis (PP), then 15 minutes, 2 hours, 24 hours and 7 days after end of IMP administration. Treatment sequence is either OctaplasLG™ or Octaplas® SD or vice versa after a minimal wash out period of 1 month. The overall duration per subject will be 1.5 months and a treatment performed on 2 days.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase I
Drug / device / biological / vaccine name(s)	OctaplasLG™, Octaplas® SD
Primary outcome measure	1. Coagulation factors 2. Activated partial thromboplastin time (aPTT), prothrombin time (PT), protein C All primary and secondary endpoints will be measured before and immediately after PP and at 15 minutes, 2 hours and 24 hours post-transfusion of IMP. Haematology and clinical chemistry will be measured 7 days after end of IMP administration.
Secondary outcome measures	1. Haematology: red blood cell (RBC) count, white blood cell (WBC) count, platelets, haematocrit (Hct), haemoglobin (Hb), and plasmin inhibitor, Protein S 2. Clinical Chemistry: electrolytes, creatinine, alanine aminotransferase (ALAT), gamma-glutamyl transferase (GGT), total protein (TP) 3. Overall tolerability, vital parameters All primary and secondary endpoints will be measured before and immediately after PP and at 15 minutes, 2 hours and 24 hours post-transfusion of IMP. Haematology and clinical chemistry will be measured 7 days after end of IMP administration.
Overall study start date	01/07/2009
Completion date	01/10/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	60
Key inclusion criteria	1. Subject must be capable of understanding and complying with all aspects of the protocol 2. Signed informed consent 3. Subject must be capable of understanding the plasmapheresis information sheet and sign it 4. Healthy male or female volunteers, aged 18 years or above 5. Women must have a negative pregnancy test (human chorionic gonadotrophin [HCG]-based assay) 6. Women must have sufficient methods of contraception (e.g. intrauterine device, oral contraception, etc.) 7. Subjects must have no clinically relevant abnormalities in medical history and general physical examination 8. Standard health insurance
Key exclusion criteria	1. Pregnancy or lactation 2. Tattoos within the last 3 months 3. Subject was treated therapeutically with FFP, blood or plasma derived products in the previous 6 months 4. Subjects have a hypersensitivity to blood products or plasma protein 5. History of angioedema 6. History of coagulation or bleeding disorder or any other known abnormality affecting coagulation, fibrinolysis or platelet function 7. Any clinically significant abnormal laboratory values 8. IgA deficiency 9. Seropositivity for HBs-Ag, HCV, HIV-1/2 antibodies 10. Symptoms of a clinically relevant illness within 3 weeks before the first trial day 11. Subjects with a history of, or suspected, drug or alcohol abuse 12. Subjects currently participating in another clinical study 13. Any IMP administration within the last 4 weeks
Date of first enrolment	01/07/2009
Date of final enrolment	01/10/2010

Locations

Countries of recruitment

Austria

Study participating centre

Oberlaaerstrasse 235

Vienna
1100
Austria

Sponsor information

Octapharma AG (Switzerland)
Industry

Seidenstrasse 2
Lachen
8853
Switzerland

Phone	+41 (0)55 4512121
Email	friedrich.kursten@octapharma.at
Website	http://www.octapharma.com
"ROR"	https://ror.org/002k5fe57

Funders

Funder type

Industry

Octapharma AG (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan