Clinical trials: CFD
Impaired Hepatic Function, Healthy
Study of ALXN2050 in Participants With Hepatic Impairment
This study will investigate the impact of impaired hepatic function (IHF) on the plasma pharmacokinetics of ALXN2050 in order to provide dosing recommendations for future indications in individuals with varying degrees of IHF.
- Trial name
- NCT05259085
- Testing
- ALXN2050
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
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 Multiple Doses of Danicopan in Healthy Participants
This was a multiple ascending dose, randomized, double-blind study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants.
- Trial name
- NCT04889690
- Testing
- Danicopan
- Where
- New Zealand
- Volunteers
- 45 people, healthy volunteers welcome
- 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.
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
Healthy
A Study of Multiple Doses of ALXN2050 in Healthy Adults
This was a Phase 1, placebo-controlled, randomized, double-blind (participant and investigator blind, sponsor open), multiple-ascending dose study conducted in healthy participants to demonstrate the safety and tolerability and…
- Trial name
- NCT05047484
- Testing
- ALXN2050
- Where
- New Zealand
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hepatocellular Carcinoma (HCC), Liver Cancer, Adult
An Innovative CFD-based Dosimetry and Pre-treatment Planning Platform to Support Personalized Transarterial Therapies for Liver Cancer
Transarterial radioembolization (TARE) is a key treatment option for patients with unresectable hepatocellular carcinoma (HCC), a primary form of liver cancer.
- Conditions
- Hepatocellular Carcinoma (HCC), Liver Cancer, Adult, Liver Cancer
- Trial name
- NCT07315633
- Testing
- Endovascular treatment
- Where
- Belgium
- Volunteers
- 80 people
- Sponsor
- University Hospital, Ghent
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.
Healthy
A Drug Interaction Study Between Danicopan and Midazolam, Fexofenadine, and Mycophenolate Mofetil in Healthy Participants
The purpose of this study was to determine the potential drug interaction between danicopan (ACH-0144471) and midazolam, fexofenadine, and mycophenolate mofetil.
- Trial name
- NCT03108274
- Testing
- Danicopan, Midazolam, Fexofenadine
- Where
- New Zealand
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
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.
Obstructive Sleep Apnea Syndrome
Validation of Functional Imaging as Predictive Tool for Outcome of Mandibular Replacement Appliance Therapy in Obstructive Sleep Apnea Hypopnea Syndrome Patients
In this open prospective study 40 patients who received Mandibular Replacement Appliance (MRA) Therapy as treatment of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) will be included.
- Trial name
- NCT01524510
- Testing
- CT scan, Alice PDx polygraphy
- Where
- Belgium
- Volunteers
- 40 people
- Sponsor
- University Hospital, Antwerp
Healthy
A Drug Interaction Study of Danicopan
This was a 3-part study (Part 1, Part 2, Part 3) with each part being an open-label, fixed sequence, 2-period study in healthy adult participants.
- Trial name
- NCT04709094
- Testing
- Danicopan, Warfarin, Bupropion
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy
Study of a Single Dose of Danicopan in Healthy Participants
This was a single ascending dose, randomized, double-blind study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants.
- Trial name
- NCT04889677
- Testing
- Danicopan
- Where
- New Zealand
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hepatic Impairment
Study of Danicopan in Participants With Hepatic Impairment
The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics (PK) of ACH-0144471 (danicopan) in participants with hepatic impairment (HI) as compared to healthy matched participants.
- Trial name
- NCT03555539
- Testing
- Danicopan
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy
A Study of Modified Release Formulations of Danicopan in Healthy Adult Participants
The purpose of this study was to evaluate and compare the plasma pharmacokinetic profiles of ACH-0144471 (danicopan) in healthy participants after administration of single oral doses of modified release prototype formulations.
- Trial name
- NCT03384186
- Testing
- Danicopan Modified Release Prototype 1, Danicopan Modified Release Prototype 2, Danicopan Modified Release Prototype 3
- Where
- United Kingdom
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy
A Study of the Cardiac Effects of ALXN2050 in Healthy Adults
This is a randomized, double-blind, double-dummy, placebo- and positive-controlled parallel study to evaluate the effect of ALXN2050 on the QT interval in healthy adult participants.
- Trial name
- NCT04660890
- Testing
- ALXN2050, Moxifloxacin
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Refractory Angina Pectoris, Gene Transfer
Adenovirus Vascular Endothelial Growth Factor D (AdvVEGF-D) Therapy for Treatment of Refractory Angina Pectoris
The purpose of the study is to evaluate the safety and efficacy of catheter mediated endocardial adenovirus-mediated vascular endothelial growth factor-D (AdVEGF-D) regenerative gene transfer in patients with refractory angina to…
- Conditions
- Refractory Angina Pectoris, Gene Transfer, Coronary Artery Disease
- Trial name
- ReGenHeart (NCT03039751)
- Testing
- AdvVEGF-D, Control Rx
- Where
- 2 sites in Denmark, Finland
- Volunteers
- 63 people
- Sponsor
- Kuopio University Hospital
Bicuspid Aortic Valve (BAV), Aortic Aneurysm
Research on Aneurysm Growth Prediction in Vascular Dilation Caused by Bicuspid Aortic Valve Based on VDM and CFD
Bicuspid aortic valve (BAV) is the most common congenital valvular malformation, characterized by heterogeneous phenotypic subtypes that predispose patients to secondary aortic pathologies, including valvular dysfunction and…
- Conditions
- Bicuspid Aortic Valve (BAV), Aortic Aneurysm, TAVR
- Trial name
- NCT07782918
- Testing
- Transcatheter Aortic Valve Replacement
- Where
- 2 sites in China
- Volunteers
- 1,000 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Acute Myeloid Leukemia
Decitabine+Cladribine+Cytarabine+Granulocyte Colony-stimulating Factor (D-CLAG) for Relapsed or Refractory Acute Myeloid Leukemia (AML)
A prospective, single-arm, multicenter, exploratory study to evaluate the efficacy and safety of D-CLAG regimen in the treatment of relapsed or refractory acute myeloid leukemia
- Trial name
- NCT04373395
- Testing
- D-CLAG
- Where
- China
- Volunteers
- 65 people
- Sponsor
- Zhejiang University
Endometriosis, Complement System
Endometriosis and Complement System
Endometriosis is a chronic gynecological condition affecting nearly 10% of women of reproductive age. A definitive diagnosis of endometriosis requires laparoscopy.
- Conditions
- Endometriosis, Complement System, Alternative Complement Pathway
- Trial name
- NCT06495151
- Testing
- Mannose-binding lectin-associated serine protease-3 (MASP-3) Level, Adipsin Level, Properdin Level
- Where
- Turkey (Türkiye)
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Ankara City Hospital Bilkent