Condition category
Not Applicable
Date applied
13/01/2009
Date assigned
14/01/2009
Last edited
23/03/2010
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

2008-004797-40

ClinicalTrials.gov number

Protocol/serial number

UNI-110

Study information

Scientific title

Acronym

Study hypothesis

Comparison of safety, tolerability, and efficacy of universal plasma (Uniplas™ LG) versus standard S/D plasma (Octaplas™ LG) in healthy volunteers.

As of 23/03/2010 this record was updated to include the actual end date of this trial. The initial anticipated end date of this trial was 31/12/2009.

Ethics approval

Local Ethics Committee (Ethikkommission der med. Uni. Wien und des Allg. Krankenhauses der Stadt Wien [AKH]) gave approval on the 20th November 2008 (ref: 395/2008)

Study design

Double-blind block-randomised cross-over phase I study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Safety/tolerability (haemolytic transfusion reaction) after transfusion of Uniplas™ LG

Intervention

The treatment day will start with plasmapheresis (600 ml) then transfusion of either Uniplas™ LG or Octaplas™ LG will be randomly assigned. Safety and tolerability will be assessed by clinical and laboratory parameters (haematology, complement activation, immune haematology). Efficacy will be measured by assessing coagulation factors. 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 investigational medicinal product (IMP) administration. Treatment sequence is either Uniplas™ LG or Octaplas™ LG or vice versa after a minimal wash out period of 1 month. The overall duration per subject will be 4 months including 3 months follow up and a treatment performed on 2 days.

Intervention type

Drug

Phase

Phase I

Drug names

Plasma (Uniplas™ LG, Octaplas™ LG)

Primary outcome measures

Haemoglobin (Hb), measured before and immediately after PP and at 15 minutes, 2 hours, 24 hours, 7 days and 3 months after end of IMP administration.

Secondary outcome measures

1. Parameters of haemolysis (haptoglobin, free Hb, indirect bilirubin)
2. Complement activation (CH50, C3c, C4)
3. Immune haematology (direct antiglobulin test [DAT])
4. Haematology (red blood cell [RBC] count, white blood cell [WBC] count, platelets, haematocrit [Hct])
5. Haemostatic parameters (activated partial thromboplastin time [aPTT], prothrombin time [PT], fibrinogen [Fbg], factor II [FII], factor V [FV], factor VII [FVII], factor VIII [FVIII], factor IX [FIX], factor X [FX], factor XI [FXI], protein S, plasmin inhibitor)
6. Changes in viral status over the study period (anti-HIV-1/2, HBsAg, hepatitis B core antigen [anti-HBc], anti-HCV, cytomegalovirus antigen [anti-CMV], hepatitis A virus antibody [anti-HAV], anti-Parvovirus B19)
7. Overall tolerability, vital parameters including body temperature, standard safety laboratory parameters

All primary and secondary endpoints will be measured before and immediately after PP and at 15 minutes/2 hours post-transfusion of IMP. The following extra timepoints will also be used:
1. 24 hours after end of IMP administration: haematology, DAT, complement and coagulation factors
2. 7 days after end of IMP administration: haematology, DAT and complement
3. 3 months after end of IMP administration: haematology, DAT, aPTT, PT, Fbg, and viral markers

Overall trial start date

01/01/2009

Overall trial end date

02/02/2010

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. Fulfil criteria of plasma donors according to a standard questionnaire for blood components donors of the Department of Blood Group Serology and Transfusion Medicine
4. Healthy male or female volunteers greater than or equal to 18 years of age
5. Blood group A, B or AB
6. Women must have a negative pregnancy test (human chorionic gonadotropin [HCG]-based assay)
7. Women must have sufficient methods of contraception (e.g. intrauterine device, oral contraception)
8. Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
9. Standard health insurance

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Pregnancy or lactation
2. Refusal to accept blood products
3. Tattoos within the last 3 months
4. Treatment with fresh frozen plasma (FFP) or blood products in the previous 6 months
5. Subjects with a history of hypersensitivity reaction in general or hypersensitivity to blood products or plasma protein in particular
6. History of angioedema
7. History of coagulation or bleeding disorder or any other known abnormality affecting coagulation, fibrinolysis or platelet function
8. Any other clinically relevant history of disease
9. Any clinically significant abnormal laboratory values including Immmunoglobulin A (IgA) deficiency
10. Seropositivity for hepatitis B surface antigens (HBsAg), hepatitis C virus (HCV), human immunodeficiency virus 1/2 (HIV-1/2) antibodies
11. Symptoms of a clinically relevant illness within 3 weeks before the first trial day
12. Subjects with a history of, or suspected, drug or alcohol abuse
13. Subjects participating in another clinical study currently or during the past 1 month

Recruitment start date

01/01/2009

Recruitment end date

02/02/2010

Locations

Countries of recruitment

Austria

Trial participating centre

Oberlaaerstrasse 235
Vienna
1100
Austria

Sponsor information

Organisation

Octapharma AG (Switzerland)

Sponsor details

Seidenstrasse 2
Lachen
CH-8853
Switzerland
+41 (0)55 451 2121
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