Clinical trials: CFD
Paroxysmal Nocturnal Hemoglobinuria
Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)(ALPHA)
The main objective of this study is to evaluate the efficacy of danicopan as add-on therapy to a complement component 5 (C5) inhibitor (eculizumab or ravulizumab) in participants with PNH who have clinically evident EVH.
- Trial name
- NCT04469465
- Testing
- Danicopan, C5 Inhibitor
- Where
- 62 sites in United States, Brazil and 16 more
- Volunteers
- 86 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Paroxysmal Nocturnal Hemoglobinuria
A Long-term Safety and Efficacy Study of Danicopan as an Add-on Therapy to Complement Component 5 Inhibitor (C5i) in Participants With PNH
This is a single-arm long-term extension study that will enroll participants with PNH who have completed participation in Alexion-sponsored clinical studies with danicopan as an add on therapy to a C5i.
- Trial name
- NCT05389449
- Testing
- Danicopan
- Where
- 45 sites in United States, Brazil and 13 more
- Volunteers
- 80 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy
Study to Evaluate the Safety, Tolerability of BCX9930 in Participants With Either Complement 3 Glomerulopathy (C3G), Immunoglobulin A Nephropathy (IgAN), or Primary Membranous Nephropathy (PMN)
The objective of this study was to determine the safety and therapeutic potential of BCX9930 in participants with C3G, IgAN, or PMN.
- Conditions
- Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, Membranous Nephropathy
- Trial name
- RENEW (NCT05162066)
- Testing
- BCX9930
- Where
- 11 sites in France, Italy and 2 more
- Volunteers
- 2 people
- Sponsor
- BioCryst Pharmaceuticals
Renal Insufficiency, Chronic
VasQ and Hemodynamic Conditions in AVFs
End-stage renal disease (ESRD) is a growing global health problem, strictly connected with progressive ageing population and longer survival of patients living on renal replacement therapy.
- Trial name
- RESHAPE (NCT04141852)
- Testing
- Implantation of VasQ device
- Where
- Italy
- Volunteers
- 6 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Healthy
Study of the Metabolism of Danicopan in Healthy Adults
This is a 2-part open-label, randomized, single-dose, 3-sequence, 3-period crossover, relative bioavailability, and food-effect study comparing different formulations of danicopan in healthy adult participants.
- Trial name
- NCT04609696
- Testing
- Danicopan: Powder-In-Capsule 1, Danicopan: Powder-In-Capsule 2, Danicopan: Tablet
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Renal Impairment, Healthy
Study of ALXN2050 in Participants With Renal Impairment
This study will investigate the impact of impaired renal function on the plasma pharmacokinetics of ALXN2050 in order to provide dosing recommendations for future indications in individuals with impaired renal function.
- Trial name
- NCT04623710
- Testing
- ALXN2050
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Obstructive Sleep Apnea
Improving Outcomes in Pediatric Obstructive Sleep Apnea With Computational Fluid Dynamics
To create a validated computational tool to predict surgical outcomes for pediatric patients with obstructive sleep apnea (OSA).
- Trial name
- OSA-MRI (NCT04991389)
- Testing
- 129-Xe
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Coronary Artery Disease
Diagnostic Accuracy of CFD-Based Fractional Flow Reserve Derived From Coronary Angiography
This is a prospective, multicenter, self-control clinical trial designed to assess the efficacy of AccuFFRangio, a novel method for evaluating the functional significance of coronary stenosis from coronary angiography, with FFR…
- Trial name
- ACCURATE (NCT04814550)
- Testing
- FFR
- Where
- China
- Volunteers
- 318 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Chronic Obstructive Pulmonary Disease
Computed Tomography (CT) and Lung Function Data Collection for Computational Fluid Dynamics (CFD) in Chronic Obstructive Pulmonary Disease (COPD) Patients
In this study, 20 COPD patients will undergo a high-resolution/multi slice CT scan and lung function tests to obtain patient specific geometries of the central and peripheral small airways and patient specific boundary…
- Trial name
- NCT00966459
- Testing
- Computed Tomography
- Where
- Belgium
- Volunteers
- 20 people
- Sponsor
- University Hospital, Antwerp
Paroxysmal Nocturnal Hemoglobinuria
First-in-Human Study of BCX9930 in Healthy Volunteers and Patients With PNH
This is a 3-part Phase 1 dose-ranging study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single (Part 1) and multiple (Part 2) ascending doses of BCX9930 in healthy subjects and in subjects with…
- Trial name
- NCT04330534
- Testing
- BCX9930
- Where
- 4 sites in Austria, South Africa and 1 more
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- BioCryst Pharmaceuticals
Healthy
A Study of Single-dose ALXN2050 in Healthy Adults
This was a phase 1, first-in-human, single-center, randomized, double-blind (participants and investigator blind, sponsor open) placebo-controlled, single-ascending dose study of ACH-0145228 (ALXN2050) conducted in healthy adult…
- Trial name
- NCT05047458
- Testing
- ALXN2050
- Where
- New Zealand
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Lupus Nephritis, Immunoglobulin A Nephropathy
Study of ALXN2050 in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of ALXN2050 (120 and 180 milligrams [mg]) in addition to background therapy consistent with the standard of care in adult participants (≥ 18 to ≤…
- Conditions
- Lupus Nephritis, Immunoglobulin A Nephropathy, IgAN, LN
- Trial name
- NCT05097989
- Testing
- ALXN2050
- Where
- 71 sites in United States, Argentina and 14 more
- Volunteers
- 100 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy
Study of Danicopan in Participants of Japanese Descent
This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of danicopan after a single-dose oral administration under fed and fasting conditions to participants of Japanese descent.
- Trial name
- NCT04451434
- Testing
- Danicopan
- Where
- Australia
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy
Study of Different Forms of Danicopan (Tablet, Softgel Capsule, Liquid-filled Capsule) in Healthy Participants
This was a randomized, crossover, open-label study to assess the relative bioavailability, pharmacokinetics (PK), and safety of three different formulations of danicopan (tablet, softgel capsule, liquid-filled capsule [LFC]) in…
- Trial name
- NCT04940559
- Testing
- Danicopan - Tablet, Danicopan - Softgel, Danicopan - LFC
- Where
- New Zealand
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Paroxysmal Nocturnal Hemoglobinuria, PNH
A Long-Term Safety Study of BCX9930 in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
This study was designed to evaluate the long-term safety of daily oral treatment with BCX9930 in participants who had participated in a previous BCX9930 trial for PNH and showed a benefit of treatment as determined by the…
- Trial name
- NCT04702568
- Testing
- BCX9930, Eculizumab, Ravulizumab
- Where
- 5 sites in Austria, South Africa and 1 more
- Volunteers
- 19 people
- Sponsor
- BioCryst Pharmaceuticals
Healthy
A Study to Assess ACH-0145228 When Administered as Immediate Release Tablet Versus Powder-In-Capsule in Healthy Adult Participants
This will be an open-label, 3-sequence, 3-period crossover study in healthy adult participants to assess the relative bioavailability of ACH-0145228 when administered as an immediate release tablet versus powder-in-capsule.
- Trial name
- NCT04551586
- Testing
- ACH-0145228: Immediate Release, ACH-0145228: Powder-in-capsule
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy, Renal Dysfunction
Study of Danicopan in Participants With Normal Kidney Function and Participants With Kidney Dysfunction
This was an open-label, nonrandomized, multi-center, single-dose, parallel group study to evaluate the effect of severe renal impairment (RI) on the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan…
- Trial name
- NCT04935294
- Testing
- Danicopan
- Where
- 4 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Paroxysmal Nocturnal Hemoglobinuria (PNH)
BCX9930 for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) in Participants Not Receiving Other Complement Inhibitor Therapy
The purpose of this study was to determine the efficacy and safety of BCX9930 monotherapy for the treatment of adult participants with PNH not currently receiving complement inhibitor therapy.
- Trial name
- REDEEM-2 (NCT05116787)
- Testing
- BCX9930 monotherapy
- Where
- 5 sites in Malaysia, South Africa and 1 more
- Volunteers
- 12 people
- Sponsor
- BioCryst Pharmaceuticals
Thoracic Outlet Syndrome, Sport Injury
CFD Analysis and Risk of TOS in Sport
Thoracic outlet syndrome (TOS) may complicate the activities of sporty subjects that participate in sports that involves upper extremities activities, such as baseball, tennis, swimming, rowing, volleyball, rugby football, and…
- Trial name
- COFLUTOSPO (NCT04428125)
- Testing
- Magnetic Resonance Scan of Thoracic outlet region, Duplex Ultrasound assessment of Upper limbs
- Where
- Italy
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Catanzaro
Atherosclerosis and Blood Flow in Coronary Artery
Geometrical Influences on Atherosclerosis and Blood Flow
The study investigates the use of advanced imaging techniques and computational methods to identify high-risk plaques in coronary arteries.
- Trial name
- NCT07002697
- Where
- Bangladesh
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bangladesh University of Engineering and Technology