Intercept Blood System For Rbcs, Infusion Of Autologous Radiolabeled Rbcs
Healthy Subjects
Phase II
Recruiting
A Recovery and Lifespan Study Using INTERCEPT Red Blood Cells Prepared Using the INTERCEPT Blood System for RBCs With AS-1
Apr 28, 2025
―
Intercept Blood System For Platelets With Led Illuminator
Healthy Subjects
Phase II
Not Yet Recruiting
A Study to Assess Recovery and Survival of Radiolabeled Apheresis Platelet Components Treated with the INTERCEPT Blood System for Platelets with LED Illuminator.
Nov 18, 2024
―
Intercept Treated Platelets
Healthy
Phase II
Completed
In Vivo Study to Assess the Recovery and Survival of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for up to 7 Days
Jul 09, 2019
―
Control, Intercept
Anemia
Phase III
Completed
Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients
Mar 02, 2018
―
Intercept Blood System For Red Blood Cells, Conventional (Control)
Anemia
Phase III
Recruiting
INTERCEPT Blood System for RBCs Study in Regions at Potential Risk for Zika Virus Transfusion-Transmitted Infections
Jan 26, 2017
―
Autologous Apheresis Platelet Components, Prepared With The Intercept Blood System For Platelets., Autologous Apheresis Conventional Untreated Platelet Components
Healthy
Phase II
Terminated
A Randomized, Multi-center, Open-label, Paired Controlled, Crossover In Vivo Study
Dec 02, 2015
―
Intercept Treated Platelets
Healthy
Phase II
Completed
A Controlled, In Vivo, Pilot Study to Assess the Recovery and Survival of Radiolabeled Autologous INTERCEPT Treated 7-Day Stored Apheresis Platelet Components in 35% Plasma and 65% InterSol and 7-Day Stored Apheresis Platelet Components in 100% Plasma
Nov 10, 2014
―
Intercept Plasma
Acute Ebola Virus Disease
Phase I
Terminated
A Prospective, Open Label, Phase 1 Safety Study of Passive Immune Therapy During Acute Ebola Virus Disease Using Transfusion of INTERCEPT Plasma Prepared From Volunteer Donors Who Have Recovered From Ebola Virus Disease
Nov 04, 2014
―
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Cerus Corp (CU2) have in its pipeline
CU2 is currently developing the following drugs: Pathogen Reduced Red Blood Cells, Intercept Rbcs, Intercept Blood System For Rbcs, Infusion Of Autologous Radiolabeled Rbcs. These drug candidates are in various stages of clinical development as the company works toward FDA approval.