A comparison of safety, tolerability and efficacy of universal plasma (Uniplas™ LG) versus standard S/D plasma (Octaplas™ LG) in healthy volunteers: a randomised, double-blind, cross-over trial
| ISRCTN | ISRCTN09913683 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09913683 |
| EudraCT/CTIS number | 2008-004797-40 |
| Secondary identifying numbers | UNI-110 |
- Submission date
- 13/01/2009
- Registration date
- 14/01/2009
- Last edited
- 23/03/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
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
Scientific
Oberlaaerstrasse 235
Vienna
1100
Austria
| Phone | +43 (0)1 61032 1791 |
|---|---|
| claudia.walasek@octapharma.com |
Study information
| Study design | Double-blind block-randomised cross-over phase I study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Plasma (Uniplas™ LG, Octaplas™ LG) |
| Primary outcome measure | 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 study start date | 01/01/2009 |
| Completion date | 02/02/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 02/02/2010 |
Locations
Countries of recruitment
- Austria
Study participating centre
Oberlaaerstrasse 235
Vienna
1100
Austria
1100
Austria
Sponsor information
Octapharma AG (Switzerland)
Industry
Industry
Seidenstrasse 2
Lachen
CH-8853
Switzerland
| Phone | +41 (0)55 451 2121 |
|---|---|
| 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 |
