INTERCEPT Safety Evaluation in Anemic Patients

NCT03486054 | Withdrawn

• 1 other identifier: 702005
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The pathogen reduction (PR) system for Whole Blood (WB) using Amustaline (S-303) and Glutathione (GSH) has a potential to decrease transfusion-transmitted infection. There is 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 gather data to support the safety of whole blood products that underwent treatment with amustaline and glutathione and data to support a larger sufficiently powered efficacy study. This study will evaluate the safety of the system for whole blood in adult patients with anemia. This study is designed as a randomized, controlled, open-label study. The aim is to explore the safety of the whole blood product treated with a PR system using amustaline and glutathione. The study will enroll 20 patients with anemia. 20 patients will be randomized either to treated WB (Test) or Standard of Care, either Red Blood Cells or Whole Blood (Control).

Conditions

Anemia

Keywords

Anemia; Transfusion; Pathogen inactivation; low-resource; Sub-saharan Africa; Côte d'Ivoire; Transfusion-transmitted infection; Red Blood Cells; Whole blood; Pathogen reduction

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), 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

  58 (+/-7)

• Treatment-emergent antibodies

  58 (+/-7)

• Treatment-emergent auto-antibodies

  58 (+/-7)

• Hemoglobin increment

  24 hours

Study Arms (2)

Experimental Arm A

EXPERIMENTAL

Whole blood treated with amustaline and glutathione, a pathogen reduction technology (PRT), ordered and administered to study patients by their treating physicians

Device: INTERCEPT

Control Arm B

ACTIVE COMPARATOR

Standard of Care (either red blood cells or whole blood)

Device: Standard of Care

Interventions

INTERCEPT DEVICE

The pathogen reduction process begins with a unit of whole blood collected according to local standards and procedures at the blood center. The blood unit is treated with amustaline and glutathione (INTERCEPT blood system for whole blood) according to manufacturer's instructions. The INTERCEPT blood system is performed on a single unit of not leuco-reduced whole blood treated with amustaline and glutathione in CPD

Also known as: Experimental

Experimental Arm A

Standard of Care DEVICE

The control article is Standard of Care, either RBC or whole blood collected by the Centre National de Transfusion Sanguine (CNTS), processed according to the local procedure and in compliance with quality criteria defined by the manufacture regarding the volume, hemoglobin content, hematocrit, storage temperature, age of blood and storage in the predefined anticoagulant solution.

Also known as: Control

Control Arm B

Eligibility Criteria

• Age: 18 Years+
• 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 have a hemoglobin level of \>/= 5.0 g/dl. Patients with hemoglobin levels of \>7.0 will not be excluded provided the patient's physician deems transfusion is needed to address anemia-induced symptoms.
• Patients must sign informed consent 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 TTI. Patients may participate in the main trial and decline collection of specimens for future research on TTI.
• 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:

• Stable anemic patients according to local clinical guidelines qualified to receive a transfusion in a non-emergency situation.
• Patients must be18 years of age or older;
• Patients must have a hemoglobin level of \>/= 5.0 g/dl. Patients with hemoglobin levels of \>7.0 will not be excluded provided the patient's physician deems transfusion is needed to address anemia-induced symptoms.
• Patients must sign informed consent 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 TTI. Patients may participate in the main trial and decline collection of specimens for future research on TTI.
• 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).
• Patients with blood group AB (due to concern of limited supply).
• Positive antibody screening reaction specific to red blood cells treated by 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 CTCAE v5.0.
• Lifelong history of major bleeding due to congenital or acquired coagulopathy.
• History of thrombosis or thromboembolic events.
• Blood in urine or feces in the last 30 days.

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, MD

  Transfusion SRC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomized, controlled, open-label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental Arm: INTERCEPT Treated Whole Blood Control Arm: Standard of Care (Red Blood Cells, Whole Blood)

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: April 3, 2018
• Study Start: June 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: June 1, 2020
• Last Updated: December 13, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share