Trial document




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  DRKS00003241

Trial Description

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Title

Open Phase IA Clinical Trial on Safety and Tolerance of Autologous UVC-treated Single Donor Platelet Concentrates in Healthy Volunteers-Dose Escalation Study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Photodynamic and photochemical pathogen inactivation are promising new techniques developed to improve the safety of blood products.
The UVC irradiation procedure using the Theraflex UV system is intended to reduce the risk of platelet transfusion transmitted infectious diseases like virus, bacteria and protozoa in conventional human, plasma reduced, leukocyte depleted platelet concentrates. Pathogen inactivation is performed by irradiation of the PCs with UVC light without using photoactive reagents.
The aim of this clinical trial is to evaluate the safety and tolerance of autologous UVC-treated single donor platelet concentrates in a dose escalation study. Safety and tolerance is assessed by measuring laboratory parameters, vital parameters and signs and symptoms. The occurrence of adverse events will be documented. Additionally, corrected count increments will be determined after administration of PCs. Each participant will be transfused with a total of 4 single UVC-treated autologous PCs within 3 series. Each series consists of platelet apheresis, UVC treatment of PCs and retransfusion. The series will be about 2 to 2.5 weeks apart.








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Brief Summary in Scientific Language

Photodynamic and photochemical pathogen inactivation are promising new techniques developed to improve the safety of blood products.
The UVC irradiation procedure using the Theraflex UV system is intended to reduce the risk of platelet transfusion transmitted infectious diseases like virus, bacteria and protozoa in conventional human, plasma reduced, leukocyte depleted platelet concentrates.
The UVC-procedure for the pathogen inactivation of plasma-reduced platelet concentrates (PCs) was developed on the basis of UVC irradiation. It inactivates pathogens mainly by its direct interaction with nucleic acids (RNA and DNA) by forming bonds (dimers) within their nucleic acid which as consequence inhibit their replication.

The pathogen reduction system works without the addition of a potentially toxic photoactive substances or new ingredients.
The aim of this clinical trial is to evaluate the safety and tolerance of autologous UVC-treated single donor platelet concentrates in a dose escalation study. The safety and tolerance of the doses escalation study will be assessed by measuring the parameters platelet count, quick value, activated partial thromboplastine time (aPPT), fibrinogen and D-dimers. Safety variables like blood pressure, pulse rate, signs and symptoms will be measured and the occurrence of adverse events will be documented. Additionally, corrected count increment (1 and 24h) will be recorded as a parameter of the haematology properties of the transfused platelets.

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Organizational Data

  •   DRKS00003241
  •   2011/08/30
  •   [---]*
  •   no
  •   Approved
  •   MV 01/11, Ethikkommission an der Medizinischen Fakultät der Ernst-Moritz-Arndt-Universität Greifswald
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Secondary IDs

  •   2010-023404-26 
  •   1289/01 
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Health Condition or Problem studied

  •   D69.6 -  Thrombocytopenia, unspecified
  •   10024922: low platelets
  •   Pathogen inactivation of platelet concentrates
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Interventions/Observational Groups

  •   In total 3 series of autologous transfusion of autologous single UVC-treated platelet concentrate (PC) will be performed. In the first series, participants will be treated with increasing partial dosis (1/8; 1/4; 1/2) of a single PC (approx. 350mL) at intervals of 30 min. In the second series a full PC and in the third PC double PC (approx. 700 mL) will be transfused. Time interval between each series will be about 2.0-2.5 weeks.
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   I
  •   [---]*
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Primary Outcome

The primary objective is the demonstration of safety and tolerance of the administration of autologous UVC-treated PCs stored for 2+ days before administration as assessed by measuring the parameters platelet count, Quick value, activated partial thromboplastine time (aPPT), fibrinogen and D-dimers

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Secondary Outcome

Secondary objectives are the assessments of further safety variables (blood pressure, pulse rate, signs and symptoms) and the determination of CCIs at 1 and 24 hours after administration of full doses of autologous UVC-treated PCs stored for 2+ and of full and double doses of autologous UVC-treated PCs stored for 2+ days before administration

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/11/04
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   40   Years
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Additional Inclusion Criteria

1. Healthy according to medical history, physical examination, and laboratory testing, as laid down in the German Haemotherapy Guidelines for allogeneic blood donation, including suitability of veins for apheresis procedures

2. Suitability of subjects to undergo double apheresis procedures

3. Aged 18 up to and including 40 years

4. Male

5. Oral and written information to the subjects on the clinical trial and written informed consent maximally one week and at least 1 day before start of first apheresis procedure

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Exclusion Criteria


1. Participation in a clinical trial of medicinal products within the preceding 3 months (i.e. 90 days).
2. Intended surgeries or dental surgery within the next 6 months (i.e. 180 days).
3. Acute or history of allergic reactions to components of PCs.
4. Known presence of refractoriness to PCs
5. Drug abuse (including alcohol misuse, checked by use of the routine blood donor questionnaire).
6. Legal incapacity or other circumstances preventing the volunteer from understanding the nature, meaning and implications of the clinical trial.
7. History of abnormal bleeding, thrombosis or thrombophilic diathesis.


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Addresses

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    • Blutspendedienst der Landesverbände des Deutschen Roten Kreuzes Niedersachsen, Sachsen-Anhalt, Thüringen, Oldenburg und Bremen gGmbH (DRK-BSD NSTOB)
    • Eldagsener Str. 38
    • 31832  Springe
    • Germany
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    • Abteilung Transfusionsmedizin, Institut für Immunologie und Transfusionsmedizin, Universitätsmedizin Greifswald Körperschaft des öffentlichen Rechts
    • Mr.  Prof.  Andreas  Greinacher 
    • Ferdinand-Sauerbruch-Str.
    • 17475  Greifswald
    • Germany
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    • Abteilung Transfusionsmedizin, Institut für Immunologie und Transfusionsmedizin, Universitätsmedizin Greifswald Körperschaft des öffentlichen Rechts
    • Mr.  Dr. med.  Thomas   Thiele 
    • Ferdinand-Sauerbruch-Str.
    • 17475   Greifswald
    • Germany
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Sources of Monetary or Material Support

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    • DRK-BSD-NSTOB
    • Eldagsenerstr.38
    • 31832  Springe
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/04/15
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Trial Publications, Results and other Documents

  •   Thiele et al. (2015): Tolerance of platelet concentrates treated with UVC-light only for pathogen reduction--a phase I clinical trial. Vox Sang Vol. 109 (1) 44-51
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* This entry means the parameter is not applicable or has not been set.