Condition category
Injury, Occupational Diseases, Poisoning
Date applied
03/09/2009
Date assigned
04/09/2009
Last edited
28/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Claudia Walasek

ORCID ID

Contact details

Oberlaaerstrasse 235
Vienna
1100
Austria
+43 (0)1 61032 1791
claudia.walasek@octapharma.com

Additional identifiers

EudraCT number

2009-012856-26

ClinicalTrials.gov number

Protocol/serial number

LAS-203

Study information

Scientific title

Acronym

Study hypothesis

Comparison of efficacy, safety and tolerability of OctaplasLG™ versus Octaplas® SD plasma in healthy volunteers.

Ethics approval

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)

Study design

Open-label block randomised cross-over phase I study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request patient information material

Condition

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

Phase

Phase I

Drug names

OctaplasLG™, Octaplas® SD

Primary outcome measures

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 trial start date

01/07/2009

Overall trial end date

01/10/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

01/07/2009

Recruitment end date

01/10/2010

Locations

Countries of recruitment

Austria

Trial participating centre

Oberlaaerstrasse 235
Vienna
1100
Austria

Sponsor information

Organisation

Octapharma AG (Switzerland)

Sponsor details

Seidenstrasse 2
Lachen
8853
Switzerland
+41 (0)55 4512121
friedrich.kursten@octapharma.at

Sponsor type

Industry

Website

http://www.octapharma.com

Funders

Funder type

Industry

Funder name

Octapharma AG (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes