INTERCEPT Safety Evaluation in Anemic Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03486054
• Date of registration: 06/03/2018
• Prospective Registration: Yes
• Primary sponsor: Swiss Transfusion SRC
• Public title: INTERCEPT Safety Evaluation in Anemic Patients POINT1africa
• Scientific 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.
• Date of first enrolment: June 2019
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT03486054
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Uganda

Contacts

• Name: Soraya Amar, MD
• Affiliation: Transfusion SRC

Key inclusion & exclusion criteria

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).



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Anemia

Intervention(s)

Device: Standard of Care

Device: INTERCEPT

Primary Outcome(s)

Severe Transfusion Reactions [Time Frame: 24 hours]

Secondary Outcome(s)

Hemoglobin increment [Time Frame: 24 hours]

Treatment-emergent auto-antibodies [Time Frame: 58 (+/-7)]

Treatment-emergent antibodies [Time Frame: 58 (+/-7)]

Adverse events [Time Frame: 58 (+/-7)]

Secondary ID(s)

702005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cerus Corporation