Safety of a New Technology for the Treatment of Whole Blood (POINT1africa)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03486054|
Recruitment Status : Not yet recruiting
First Posted : April 3, 2018
Last Update Posted : February 18, 2019
The pathogen inactivation (PI) 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 cancer patients with anemia.
This study has a two-stage design. Stage 1 is designed as a randomized, double-blind stage, followed by Stage 2, an open-label, single arm treatment escalation stage. The aim is to explore the safety of the whole blood product treated with a PI system using amustaline and glutathione.
The study will enroll 30 patients with anemia due to underlying cancer. In stage1, 20 patients will be randomized either to treated WB (Test) or conventional WB (Control).
After safety assessment in Stage 1, Stage 2, a dose escalation stage will follow and enroll additional 10 patients in need of 2 WB products administered successively to correct anemia.
|Condition or disease||Intervention/treatment||Phase|
|Safety Issues||Device: INTERCEPT Device: Conventional whole blood Device: INTERCEPT (dose escalation)||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Stage 1: parallel assignement to experimental or control group Stage 2: Dose escalation group|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Randomized, double-blind Stage 1; single arm open label in Stage 2|
|Official Title:||A Randomized, Double-Blind, Phase I, Dose-Escalation Study for the Safety of Whole Blood Treated With Amustaline (S-303) and Glutathione (GSH), a Pathogen Inactivation System, and Transfused to Anemic Adult Cancer Patients.|
|Estimated Study Start Date :||August 2019|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||December 2020|
Transfusion with one bag of Whole blood treated with amustaline and glutathione, a pathogen inactivation (PI) system, ordered and administered to study patients by their treating physicians
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
Other Name: Experimental
Active Comparator: Conventional Whole Blood
Transfusion intervention with one conventional whole blood ordered and administered to study patients by their treating physicians.
Device: Conventional whole blood
The conventional whole blood unit is collected according to local standards and procedures at the blood center and stored in Citrate Phosphate Dextrose (CPD), an anticoagulant solution.
Other Name: Control
Experimental: INTERCEPT (dose escalation)
Transfusion intervention with two Whole blood treated with amustaline and glutathione, a pathogen inactivation system, ordered and administered to study patients by their treating physicians.
Device: INTERCEPT (dose escalation)
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 two units of not leuco-reduced whole blood treated with amustaline and glutathione in CPD.
Other Name: Escalation
- Severe Transfusion Reactions [ Time Frame: 24 hours ]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.
- Adverse events [ Time Frame: 75 (+/-15) ]All adverse events including transfusion reactions from start of the first transfusion to day 28 (+/-3) and all SAEs within 75 (+/-15) after study transfusion.
- Treatment-emergent antibodies [ Time Frame: 75 (+/-15) ]Treatment-emergent antibodies to INTERCEPT Red Blood Cells (RBC)s within 75 (+/-15) days after study transfusion
- Treatment-emergent auto-antibodies [ Time Frame: 75 (+/-15) ]Treatment emergent auto-antibody within 75 (+/-15) days after study transfusion
- Hemoglobin increment [ Time Frame: 24 hours ]The hemoglobin increment post transfusion will be calculated as the difference between the hemoglobin value most proximate before the transfusion and approximately 24h post transfusion, adjusted by hemoglobin content transfused.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486054
|Contact: Soraya Amar, MD||+41 31 380 firstname.lastname@example.org|
|Contact: Anja Grzesiczek||+41 31 380 email@example.com|
|Study Director:||Soraya Amar, MD||Transfusion SRC|