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
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