An open label phase I study in healthy subjects with blood group AB to investigate the safety, tolerability and efficacy of Uniplas™ LG

ISRCTN	ISRCTN45060587
DOI	https://doi.org/10.1186/ISRCTN45060587
Secondary identifying numbers	UNI-111

Submission date: 22/12/2010
Registration date: 10/01/2011
Last edited: 21/06/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Dr Friedrich Kursten
Scientific

Oberlaaerstrasse 235
Vienna
1100
Austria

Phone	+43 (0)1 61032 1245
Email	friedrich.kursten@octapharma.at

Study information

Study design	Open-label non-randomised non-controlled phase I study
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Other
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request patient information material
Scientific title
Study hypothesis	This is a trial in healthy subjects who have blood group AB to investigate the safety, tolerability and efficacy of Uniplas™ LG.
Ethics approval(s)	Local Ethics Committee (Ethikkommission der med.Uni.Wien und des Allg. Krankenhauses der Stadt Wien AKH) approved on the 12th November 2010 (ref: 779/2010)
Condition	Substitution of intentionally removed plasma
Intervention	Primary objective of this study is to investigate the safety and the tolerability of Uniplas™ LG, assessed by clinical and laboratory parameters with respect to subjects with blood group AB. IMP will be infused once and the subjects will be followed up until 3 months after administration of the IMP.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase I
Drug / device / biological / vaccine name(s)	Uniplas™ LG
Primary outcome measure	Haemoglobin (Hb), measured at baseline, less than or equal to 30 minutes before and less than 5 minutes post plasmapheresis, 15 minutes and 2 hours post-transfusion, 24 hours and 7 days post-plasmapherese and 3 months after administration of IMP.
Secondary outcome measures	1. Parameters of haemolysis: haptoglobin, free Hb, indirect bilirubin 2. Complement activation: CH50, C3c, C4 3. Circulating immune complexes (CIC): IgG, IgA, IgM 4. DAT (direct antiglobulin test) 5. Isoagglutinines (in case of a positive DAT) 6. Haematology: RBC count, WBC count, platelets, Hct, Hb 7. Standard safety lab (Clinical chemistry): sodium (Na+), potassium (K+), calcium (Ca2+), creatinine, ALAT, gamma-glutamyl transferase (gGT), total protein (TP) 8. Haemostatic Panel I: aPTT, PT, Fbg 9. Haemostatic Panel II: FII, FV, FVII, FVIII, FIX, FX, FXI, Protein C, Protein S, plasmin inhibitor) 10. Urine analysis: WBC, nitrite, pH, protein, glucose, ketones, urobilinogen, bilirubin, blood/Hb 11. Changes in viral status over the study period: anti-HIV-1/2, HBsAg, anti-HBc, anti-HCV, anti-CMV, anti-HAV, anti-Parvovirus B19 12. Overall tolerability, AE monitoring, vital signs including body temperature Measured at baseline, less than or equal to 30 minutes before and less than 5 minutes post plasmapheresis, 15 minutes and 2 hours post-transfusion, 24 hours and 7 days post-plasmapherese and 3 months after administration of IMP.
Overall study start date	01/10/2010
Overall study end date	01/04/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	4 to 6 (Study no longer recuiting: Last patient out on 28/03/2011)
Participant inclusion criteria	1. Signed written informed consent 2. Subject must be capable to understand and comply with all relevant aspects of the study protocol 3. Blood group AB 4. Healthy male or female subjects greater than or equal to 18 years of age 5. Female subject must have a negative pregnancy test (human chorionic gonadotropin [HCG]-based assay) 6. Female subject must apply sufficient methods of contraception 7. Subject must have no clinically relevant abnormalities in medical history and general physical examination 8. A standard health insurance must be in place for the subject
Participant exclusion criteria	1. Pregnancy or lactation 2. Subject got tattoos within the last 3 months 3. Subject was treated therapeutically with FFP, blood or plasma-derived products in the previous 6 months 4. Angiotensin converting enzyme (ACE)-inhibitors 5. Subject has a history of severe hypersensitivity to blood products or plasma protein 6. History of angiooedema 7. History of coagulation disorder or bleeding disorder and any known abnormality affecting coagulation, fibrinolysis or platelet function 8. Any other clinically relevant history of disease 9. Subject has clinically significant abnormal laboratory values 10. Subject has IgA deficiency 11. Seropositivity for hepatitis B surface antigens (HBsAg), hepatitis C virus (HCV), human immunodeficiency virus (HIV-1/2) antibodies 12. Symptoms of a clinically relevant illness within 3 weeks before Visit 2 13. Subject has a history of or a suspected drug or alcohol abuse 14. Participation in another clinical study within the past 4 weeks
Recruitment start date	01/10/2010
Recruitment end date	01/04/2011

Locations

Countries of recruitment

Austria

Study participating centre

Oberlaaerstrasse 235

Vienna
1100
Austria

Sponsor information

Octapharma AG (Switzerland)
Industry

Seidenstrasse 2
Lachen
CH-8853
Switzerland

Phone	+41 (0)55 451 2121
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