WithdrawnNot Applicable

INTERCEPT Safety Evaluation on Whole Blood

Stopped: Sponsor's decision

0Started 2024-01

Plain-language summary

The pathogen reduction system for whole blood using amustaline (S-303) and glutathione (GSH) hast a potential to decrease transfusion-transmitted infection. There is a scientific basis to hypothesize, that cells containing DNA and RNA such as bacteria, viruses and parasites that could be present in blood collected from asymptomatic infected donors are inactivated in the treated whole blood and therefore reduce the risk of transfusion-transmitted infections. The aim of the study is to assess the safety of whole blood treated with amustaline and glutathione and transfused in patients with anemia. This is a first-in-human-subjects study. Whole blood (WB) products treated with the amustaline (S-303) and glutathione (GSH) pathogen reduction technology have not been evaluated in human beings. However, red blood cells concentrates treated with amustaline and GSH have been evaluated in multiple clinical studies. The study described in this protocol is a randomized, controlled, open-label Phase I clinical trial. 20 patients will be randomized into either the Test or Control arm in a ratio of 1:1. 10 patients assigned to the Test arm will receive one amustaline/GSH treated whole blood product. 10 patients assigned to the Control arm will receive the Standard of Care (SOC), either one red blood cell (RBC) component or one whole blood product.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients must be18 years of age or older;
✓. Patients should have poorly tolerated anemia with a hemoglobin level greater than or equal to 5.0 g/dl and less than or equal to 7.0 g/dl. At the discretion of the investigator, inclusion is possible at a hemoglobin level greater than 7.0 g/dl if the criteria in the current local guidelines are met.
✓. Patients must sign the study's informed consent form prior to initiation of any study-specific procedure / treatment. Enrolled patients may give additional consent for specimens collected during this study to be used for future research on TTIs. Patients may participate in the main trial and decline collection of specimens for future research.
✓. Patients must agree to be hospitalized for a maximum of 72 hours after initiation of a study transfusion;
✓. Female patients of childbearing potential must:
✓. have a negative serum pregnancy test within 72 hours prior to receiving the first study blood to rule out pregnancy, and;
✓. use at least one method of birth control that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. These include combined oral contraceptives, implants, injectable, some intrauterine devices, sexual abstinence or vasectomized partner. The selected method must be used for the duration of study participation that means from day 1 (day of initiation of study transfusion) until day 58 (Final Study Visit).

What they're measuring

Severe Transfusion Reactions

Timeframe: 24 hours

Trial details

NCT IDNCT04020224

SponsorSwiss Transfusion SRC

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12

View on ClinicalTrials.gov More Safety Issues trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients must be18 years of age or older;
✓. Patients should have poorly tolerated anemia with a hemoglobin level greater than or equal to 5.0 g/dl and less than or equal to 7.0 g/dl. At the discretion of the investigator, inclusion is possible at a hemoglobin level greater than 7.0 g/dl if the criteria in the current local guidelines are met.
✓. Patients must sign the study's informed consent form prior to initiation of any study-specific procedure / treatment. Enrolled patients may give additional consent for specimens collected during this study to be used for future research on TTIs. Patients may participate in the main trial and decline collection of specimens for future research.
✓. Patients must agree to be hospitalized for a maximum of 72 hours after initiation of a study transfusion;
✓. Female patients of childbearing potential must:
✓. have a negative serum pregnancy test within 72 hours prior to receiving the first study blood to rule out pregnancy, and;
✓. use at least one method of birth control that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. These include combined oral contraceptives, implants, injectable, some intrauterine devices, sexual abstinence or vasectomized partner. The selected method must be used for the duration of study participation that means from day 1 (day of initiation of study transfusion) until day 58 (Final Study Visit).

INTERCEPT Safety Evaluation on Whole Blood

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

INTERCEPT Safety Evaluation on Whole Blood

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria