Condition category
Signs and Symptoms
Date applied
22/12/2010
Date assigned
10/01/2011
Last edited
21/06/2011
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 Friedrich Kursten

ORCID ID

Contact details

Oberlaaerstrasse 235
Vienna
1100
Austria
+43 (0)1 61032 1245
friedrich.kursten@octapharma.at

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UNI-111

Study information

Scientific title

Acronym

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

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)

Study design

Open-label non-randomised non-controlled phase I study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Other

Trial type

Diagnostic

Patient information sheet

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

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

Phase

Phase I

Drug names

Uniplas™ LG

Primary outcome measures

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 trial start date

01/10/2010

Overall trial end date

01/04/2011

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

4 to 6 (Study no longer recuiting: Last patient out on 28/03/2011)

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

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