INTERCEPT Safety Evaluation on Whole Blood

NCT04020224 | Withdrawn

• 1 other identifier: 1702005
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Safety Issues

Keywords

anemia; transfusion; pathogen inactivation; pathogen reduction; low-resource; sub-saharan africa; transfusion-transmitted infection; whole blood

Outcome Measures

Primary Outcomes (1)

• Severe Transfusion Reactions

  The primary safety outcome will be assessed by the occurrence of transfusion reactions \>= grade 2 according to the Swissmedic transfusion reaction grading and causality criteria (Appendix 1: Swissmedic Classification and Analysis of Transfusion related reactions ), during the first 24 hours following administration of each study transfusion, with probable, possible or certain causality to the transfused product.

  24 hours

Secondary Outcomes (4)

• Adverse Events

  28 days (+/-3 days)

• Treatment-induced antibodies

  58 days (+/-7 days)

• Treatment-induced auto-antibodies

  58 days (+/-7 days)

• 24 h post-transfusion hemoglobin

  24 hours

Study Arms (2)

Treatment with pathogen reduced whole blood

EXPERIMENTAL

Subjects will receive one amustaline/GSH treated whole blood product.

Device: Amustaline/GSH pathogen reduction technology

Treatment with Standard of Care

ACTIVE COMPARATOR

Subjects will receive the Standard of Care (SOC), either one red blood cell (RBC) component or one whole blood product

Device: Standard of Care

Interventions

Amustaline/GSH pathogen reduction technology DEVICE

Whole blood treated with pathogen reduction technology

Treatment with pathogen reduced whole blood

Standard of Care DEVICE

Red Blood Cell Component or whole blood

Treatment with Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be18 years of age or older;
• 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).

You may not qualify if:

• Patients with blood group AB and blood group O Rhesus negative (due to concern of limited supply).
• Positive antibody screening reaction specific to red blood cells treated with amustaline and glutathione (GSH).
• Positive red cell alloantibody screening (IAT) / presence of red cell antibodies;
• Patient has ongoing clinical-significant bleeding described as grade 2 or more according to the U.S. National Cancer Institute's CTCAE v5.0 severity grading scale.
• Lifelong history of major bleeding due to congenital or acquired coagulopathy.
• History of thrombosis or thromboembolic events.
• Blood in feces or hemoglobinuria in the last 30 days.
• Pre-transfusion thrombocyte counts of \< than 50 Giga/l (x109).
• Oral, intravenous or sub-cutaneous prophylactic or therapeutic anticoagulants.
• Central body temperature increase of ≥2°C within 24 hours before transfusion.
• Clinical signs of ongoing sepsis including fever \>39°C with signs of a systemic, inflammatory response.
• Abnormal activated partial thromboplastin time (aPTT) and/or abnormal prothrombin time (PT) or INR laboratory results
• Transfusion of a blood product within 2 weeks prior to enrollment.
• Abnormal total bilirubin (≤ 2 x upper limit of normal) levels and/or clinical signs of jaundice.
• Sickle cell anemia.

Sponsors & Collaborators

• Swiss Transfusion SRC: lead
• Cerus Corporation: collaborator

MeSH Terms

Conditions

Anemia; Transfusion Reaction

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Study Officials

• Soraya Amar, Dr

  SwissTransfusion SRC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 10 patients in the Test arm 10 patient in the Control arm

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 15, 2019
• Study Start: January 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share