Clinical trials: Apheresis
Hypercholesterolemia
Evolocumab Compared to LDL-C Apheresis in Patients Receiving LDL-C Apheresis Prior to Study Enrollment
To evaluate the efficacy of subcutaneous (SC) evolocumab, compared to regularly scheduled low-density lipoprotein cholesterol (LDL-C) apheresis, on reducing the need for future apheresis.
- Trial name
- NCT02585895
- Testing
- Evolocumab, Low-density Lipoprotein Cholesterol (LDL-C) Apheresis
- Where
- 17 sites in United States, Australia and 6 more
- Volunteers
- 39 people
- Sponsor
- Amgen
Healthy
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
The principle objective of this study is to evaluate the hypothesis that INTERCEPT Platelets in 100% plasma stored for 5 or more days (up to 7 days) after apheresis collection retain sufficient viability for therapeutic…
- Trial name
- NCT04022889
- Testing
- INTERCEPT Treated Platelets
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Cerus Corporation
Multiple Myeloma
Evaluation of the Spectra Optia® Mononuclear Cell Collection Procedure
The purpose of this investigation is to establish that hematopoetic stem cells collected on a new centrifugal blood separator, CaridianBCT's Spectra Optia Apheresis System, are able to reconstitute the hematopoetic systems of…
- Trial name
- NCT01292486
- Testing
- Spectra Optia Apheresis System
- Where
- 4 sites in United States
- Volunteers
- 32 people
- Sponsor
- Terumo BCT
Hypercholesterolemia
(H.E.L.P.)Apheresis Therapy to Compare the Reduction of LDL (Low Density Lipoprotein) Cholesterol
The primary objective of the study is to demonstrate that the performance of the modified Plasmat® Futura H.E.L.P. Apheresis System is non-inferior to the current FDA approved Plasmat® Secura H.E.L.P Apheresis System for use…
- Trial name
- FUTURA (NCT00526058)
- Testing
- Secura then Futura, Futura then Secura
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- B. Braun Medical Inc.
Thrombocythemia, Myeloproliferative Disease
Retrospective Data Collection of Routine Use With Spectra Optia® for Platelet Depletions
Multicenter, Retrospective Data Collection of Routine Clinical Use with the Spectra Optia® Apheresis System for Platelet Depletion Procedures.
- Conditions
- Thrombocythemia, Myeloproliferative Disease, Thrombocytosis
- Trial name
- PLTD (NCT02308787)
- Testing
- Spectra Optia Apheresis System
- Where
- 2 sites in Denmark, Hungary
- Volunteers
- 12 people
- Sponsor
- Terumo BCT
Familial Hypercholesterolemia
Long Term, Follow-on Study of Lomitapide in Patients With Homozygous Familial Hypercholesterolemia
This was a long term follow on study to assess the continued long term safety and efficacy of lomitapide in patients with homozygous familial hypercholesterolemia.
- Trial name
- NCT00943306
- Testing
- lomitapide
- Where
- 10 sites in United States, Canada and 2 more
- Volunteers
- 19 people
- Sponsor
- Aegerion Pharmaceuticals, Inc.
Hypercholesterolemia, Coronary Heart Disease
Safety and Efficacy of Mipomersen in Patients With Severe Hypercholesterolemia on a Maximally Tolerated Lipid-Lowering Regimen and Who Are Not on Apheresis
The purpose of the study is to evaluate the safety and efficacy of dosing with mipomersen for 26 weeks in treating severely hypercholesterolemic patients who are on a maximally tolerated lipid-lowering regimen and who are not on…
- Trial name
- NCT00794664
- Testing
- Mipomersen
- Where
- 27 sites in United States, Canada and 4 more
- Volunteers
- 58 people
- Sponsor
- Kastle Therapeutics, LLC
Heterozygous Familial Hypercholesterolemia
Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy
The primary objective of the study is to evaluate the effect of alirocumab 150 mg every 2 weeks (Q2W) in comparison with placebo on the frequency of low-density lipoprotein (LDL) apheresis treatments in participants with…
- Trial name
- ODYSSEY ESCAPE (NCT02326220)
- Testing
- Alirocumab
- Where
- 13 sites in United States, Germany
- Volunteers
- 62 people
- Sponsor
- Regeneron Pharmaceuticals
Granulocyte/ Polymorphonuclear Cells
Evaluation of the Spectra Optia PMN Cell Collection Procedure
The purpose of this study is to compare the procedures for the collection PMN cells on Terumo BCT's Spectra Optia® and COBE® Spectra Apheresis Systems.
- Trial name
- PMNC (NCT01805180)
- Testing
- Granulocyte/Polymorphonuclear Cell Collection (COBE Spectra System), Granulocyte/Polymorphonuclear Cell Collection (Spectra Optia System)
- Where
- 3 sites in United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Terumo BCT
Crohn's Disease
Study for the Treatment of Crohn's Disease With Adacolumn
The purpose of this study is to evaluate the safety and effectiveness of the Adacolumn Apheresis System as a treatment for the signs and symptoms of Crohn's disease.
- Trial name
- NCT00162942
- Testing
- Adacolumn
- Where
- 37 sites in United States, Canada
- Volunteers
- 235 people
- Sponsor
- Otsuka America Pharmaceutical
Fluid Loss
Clinical Evaluation of the CM-1500 During Apheresis Blood Donation
The study is a prospective, single-arm, non-randomized, non-blinded, non-controlled, non-significant risk, single center study enrolling up to 200 healthy adult subjects consented to undergo an apheresis donation procedure.
- Trial name
- NCT05012462
- Testing
- CM-1500, CM-1600
- Where
- United States
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Zynex Monitoring Solutions
Apheresis Related Hypotension
IMPACT (Improving Plasma Collection) Clinical Trial
Prospective, multi-center, randomized, controlled clinical trial to study the safety and effectiveness of a novel plasma collection system software.
- Trial name
- IMPACT (NCT04320823)
- Testing
- Updated Plasma Collection Feature, Current Plasma Collection Approach
- Where
- 3 sites in United States
- Volunteers
- 3,443 people, healthy volunteers welcome
- Sponsor
- Haemonetics Corporation
Multiple Myeloma, Lymphoma, Non-Hodgkin's
AMD3100 (Plerixafor) in Multiple Myeloma (MM) or Non-Hodgkin's Lymphoma (NHL) Patients Predicted to be Unable to Mobilize With G-CSF Alone
This Phase 2 study was designed to assess the safety and hematological activity of AMD3100 (plerixafor) in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who were predicted to be unable to mobilize ≥2*10^6…
- Trial name
- NCT00395967
- Testing
- G-CSF plus plerixafor
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Genzyme, a Sanofi Company
Healthy Apheresis Donors, Mononuclear (MNC) Cell Donors
An Evaluation of the Spectra Optia CMNC Collection Procedure
The purpose of this prospective, randomized, cross-over, multi-center study is to evaluate the performance of the Spectra Optia Apheresis System's CMNC Collection Procedure, compared to the COBE Spectra Apheresis System's MNC…
- Trial name
- CMNC (NCT02253160)
- Testing
- Spectra Optia CMNC, COBE Spectra MNC, Granulocyte-colony stimulating factor (G-CSF)
- Where
- 2 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Terumo BCT
Leukocytosis
Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for White Blood Cell Depletion
This study is a multicenter, retrospective data collection of routine clinical use with the Spectra Optia® apheresis system for white blood cell depletion.
- Trial name
- WBCD (NCT02302365)
- Testing
- Spectra Optia® Apheresis System
- Where
- 3 sites in Belgium, Germany and 1 more
- Volunteers
- 43 people
- Sponsor
- Terumo BCT
Sickle Cell Disease
Study of MGTA-145 and Plerixafor in Patients With Sickle Cell Disease
This research study is designed to investigate a new potential medicine for mobilizing stem cells and apheresis collection in patients with Sickle Cell Disease. MGTA-145, the new potential medicine, will be given with plerixafor.
- Trial name
- NCT05445128
- Testing
- MGTA-145, Plerixafor
- Where
- 3 sites in United States
- Volunteers
- 1 people
- Sponsor
- Ensoma
Familial Hypercholesterolemia
Low-Density Lipoprotein (LDL) Apheresis Using H.E.L.P. Therapy
The objectives of this post-surveillance study are to continue to evaluate the safety and effectiveness of the H.E.L.P. System. The safety and effectiveness will be assessed by evaluating the occurrence of death, cardiovascular…
- Trial name
- Secura (NCT00916643)
- Testing
- HELP Secura (apheresis treatment)
- Volunteers
- 113 people
- Sponsor
- B. Braun Medical Inc.
Apheresis Related Hypotension
Evaluation of the Aurora Xi New Nomogram Software 2.0
A clinical trial to evaluate the safety and effectiveness of the Aurora Xi Plasmapheresis System with a new plasma collection volume nomogram.
- Trial name
- NCT06122935
- Testing
- Aurora Xi New Nomogram Software 2.0, Aurora Xi Currently Approved Software 1.3
- Where
- 3 sites in United States
- Volunteers
- 6,735 people, healthy volunteers welcome
- Sponsor
- Fenwal, Inc.
Leukapheresis
Evaluation of the Spectra Optia® Apheresis System Mononuclear Cell (MNC) Collection Procedure in Healthy Blood Donors
The purpose of this protocol is to characterize the performance of CaridianBCT's Spectra Optia Apheresis System, when used to collect mononuclear cells (MNCs) and cluster of differentiation 34 (CD34) positive cells from healthy…
- Trial name
- NCT01277549
- Testing
- Mononuclear cell collection.
- Where
- 3 sites in United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Terumo BCT
Healthy Subjects
A Study to Assess Recovery and Survival of Radiolabeled Apheresis Platelet Components Treated With the INTERCEPT Blood System for Platelets With LED Illuminator.
The objective of this study is to assess the post-infusion recovery and survival of platelets in 100% Plasma treated with INTERCEPT Blood System for Platelets with LED Illuminator and stored for 5 days after apheresis collection.
- Trial name
- NCT06697223
- Testing
- INTERCEPT Blood System for Platelets with LED Illuminator
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Cerus Corporation