Anemia Clinical Trial
— POINT1africaOfficial title:
A Randomized, Controlled, Phase I Clinical Trial to Assess the Safety of Whole Blood Treated With Amustaline (S-303) and Glutathione (GSH), a Pathogen Reduction System in Anemic Patients.
NCT number | NCT03486054 |
Other study ID # | 702005 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2019 |
Est. completion date | June 2020 |
Verified date | December 2019 |
Source | Swiss Transfusion SRC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2020 |
Est. primary completion date | March 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Stable anemic patients according to local clinical guidelines qualified to receive a whole
blood transfusion in a non-emergency situation. Inclusion criteria: Patients must fulfill all of the following inclusion criteria: 1. Patients must be18 years of age or older; 2. 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. 3. 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. 4. Patients must agree to be hospitalized for a maximum of 72 hours after initiation of a study transfusion; 5. Female patients of childbearing potential must: 1. have a negative serum pregnancy test within 72 hours prior to receiving the first study blood to rule out pregnancy, and 2. 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). Exclusion criteria: The presence of any one of the following exclusion criteria will lead to exclusion: Stable anemic patients according to local clinical guidelines qualified to receive a transfusion in a non-emergency situation. Inclusion criteria: Patients must fulfill all of the following inclusion criteria: 1. Patients must be18 years of age or older; 2. 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. 3. 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. 4. Patients must agree to be hospitalized for a maximum of 72 hours after initiation of a study transfusion; 5. Female patients of childbearing potential must: 1. have a negative serum pregnancy test within 72 hours prior to receiving the first study blood to rule out pregnancy, and 2. 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). Exclusion criteria: The presence of any one of the following exclusion criteria will lead to exclusion: 1. Patients with blood group AB (due to concern of limited supply). 2. Positive antibody screening reaction specific to red blood cells treated by amustaline and glutathione (GSH). 3. Positive red cell alloantibody screening (IAT) / presence of red cell antibodies; 4. Patient has ongoing clinical-significant bleeding described as grade 2 or more according to CTCAE v5.0. 5. Lifelong history of major bleeding due to congenital or acquired coagulopathy. 6. History of thrombosis or thromboembolic events. 7. Blood in urine or feces in the last 30 days. 8. Pre-transfusion thrombocyte counts of < than 50 Giga/l (x109). 9. Oral, intravenous or sub-cutaneous prophylactic or therapeutic anticoagulants. 10. Central body temperature increase of = 2 °C within 24 hours before transfusion. 11. Clinical signs of ongoing sepsis including fever > 39°C with signs of a systemic, inflammatory response. 12. Abnormal activated partial thromboplastin time (aPTT) and/or abnormal prothrombin time (PT) or INR laboratory results 13. Transfusion of a blood product within 2 weeks prior to enrollment. 14. Abnormal total bilirubin (2 x upper limit of normal) levels and /or clinical signs of jaundice. 15. Previous treatment with other pathogen-reduced blood products. 16. Sickle cell anemia. 17. Malignant cancer patients having received chemotherapy within 12 months. 18. Patients in need of multiple RBC or WB transfusions in the first 24 hours according to the attending physician's judgment (i.e., more than one product). 19. Pregnant or breast feeding. 20. Inability to comply with the protocol in the opinion of the investigator. 21. Participation in any other type of clinical study either concurrently or within the previous 30 days: investigational blood products, nutrition, pharmacologic agents or imaging materials, including dyes, investigational surgical techniques, or devices (studies of psychology or socioeconomic issues are not grounds for exclusion). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Swiss Transfusion SRC | Cerus Corporation |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Adverse events | All adverse events including all transfusion reactions within 28 (+/-3) days and all SAEs within 58 (+/- 7) days after last study transfusion. | 58 (+/-7) | |
Secondary | Treatment-emergent antibodies | Treatment-induced antibodies to amustaline/GSH treated RBCs within 58 (+/-7) days after last study transfusion | 58 (+/-7) | |
Secondary | Treatment-emergent auto-antibodies | Treatment emergent auto-antibody within 58 (+/-7) days after study transfusion | 58 (+/-7) | |
Secondary | Hemoglobin increment | The hemoglobin increment 24h 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. | 24 hours |
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