Clinical trials: Processes, Metabolic
Niemann-Pick Disease, Type C1
Hydroxypropyl Beta Cyclodextrin for Niemann-Pick Type C1 Disease
Background: Hydroxypropyl beta cyclodextrin (HPBCD) is being tested for a disease called Niemann-Pick disease type C1 (NPC1). NPC1 is a genetic disorder that results in gradual loss of nervous system function.
- Trial name
- NCT01747135
- Testing
- VTS-270
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Vtesse, LLC, a Mallinckrodt Pharmaceuticals Company
Hunter Syndrome
A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase®
Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously.
- Trial name
- NCT00920647
- Testing
- Control, Idursulfase IT (1 mg), Idursulfase IT (10 mg)
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Shire
Hunter Syndrome
Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment
Study HGT-HIT-094 is a multicenter study designed to determine the effect on clinical parameters of neurodevelopmental status of monthly IT administration of idursulfase-IT 10 mg for 12 months in pediatric patients with Hunter…
- Trial name
- AIM-IT (NCT02055118)
- Testing
- idursulfase-IT, No IT treatment
- Where
- 9 sites in United States, Australia and 5 more
- Volunteers
- 58 people
- Sponsor
- Shire
Diabetes, Healthy
A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Subcutaneous Injections of Semaglutide Produced by Two Manufacturing Processes
This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) between…
- Trial name
- NCT01766245
- Testing
- semaglutide
- Where
- Germany
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Dehydration
Efficacy of Education Versus Education Plus Prescribed Fluid Intake on Hydration Status in High School Athletes
Sports science testing by investigators at Gatorade Sports Science Institute has revealed that many athletes arrive at practice with a high urine specific gravity indicating they are hypohydrated.
- Trial name
- NCT06651619
- Testing
- Water, Hydration Education
- Where
- United States
- Volunteers
- 131 people, healthy volunteers welcome
- Sponsor
- PepsiCo Global R&D
Atrial Fibrillation, Obesity
Effectiveness And Safety Of Oral Anticoagulants Among Obese Patients With Non-Valvular A-Fib In VA Patients With Medicare
The overall objective of this analysis is to understand patient characteristics, the use of treatment, and clinical outcomes among obese (overweight) and severely obese patients with non-valvular atrial fibrillation (NVAF) who…
- Conditions
- Atrial Fibrillation, Obesity, Anticoagulants
- Trial name
- NCT04681482
- Testing
- Apixaban
- Where
- United States
- Volunteers
- 107,383 people
- Sponsor
- Pfizer
Diabetes Mellitus, Type 1
INHALE-3: Afrezza® Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes
INHALE-3 is a Phase 4, randomized controlled trial (RCT) that will randomly assign participants ≥18 years of age with type 1 diabetes (T1D) using multiple daily injections (MDI), an automated insulin delivery (AID) system, or a…
- Trial name
- NCT05904743
- Testing
- Afrezza, insulin degludec, Rapid-acting Insulin Analog
- Where
- 19 sites in United States
- Volunteers
- 141 people
- Sponsor
- Mannkind Corporation
End Stage Kidney Disease (ESKD)
A Phase 1b Study to Evaluate the PK of CSL300 (Clazakizumab) in Chinese Subjects With End Stage Kidney Disease (ESKD)
This is a phase 1b, partial-blind (Sponsor unblinded), randomized, multicenter, placebo-controlled study. The primary objective of this study is to evaluate the pharmacokinetics (PK) of CSL300 after single and multiple doses in…
- Trial name
- NCT07619820
- Testing
- CSL300
- Where
- China
- Volunteers
- 24 people
- Sponsor
- CSL Behring
MASH, NASH
A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3 Fibrosis
A randomized, double-blind, placebo-controlled Phase 3 study to determine if denifanstat 50 mg or 25 mg is effective, as compared to placebo, in resolving MASH without the worsening of fibrosis and/or in fibrosis regression…
- Conditions
- MASH, NASH, Metabolic Dysfunction-associated Steatohepatitis, Noncirrhotic Metabolic Dysfunction-associated Steatohepatitis
- Trial name
- FASCINATE-3 (NCT06594523)
- Testing
- Denifanstat
- Sponsor
- Sagimet Biosciences Inc.
Hypotension
Efficacy Study of a Facemask Device to Treat Hypotension
The purpose of this study is to determine if the impedance threshold device (ITD) attached to a facemask can increase blood pressure in patients who present to the emergency department with hypotension secondary to hypovolemia.
- Trial name
- NCT00256724
- Testing
- Impedance Threshold Device
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Advanced Circulatory Systems
Neoplasm Metastasis
Study Assessing Metabolism, Excretion and Pharmacokinetics of a Poly (ADP-Ribose) Polymerase (PARP) Inhibitor in Patients With Solid Metastatic Tumours
Open, non-randomized, radiolabelled, single centre study designed to characterize the metabolism, excretion and pharmacokinetics of a single oral dose of 100 mg [14C]-radiolabelled AZD2281 (KU-0059436) in patients with advanced…
- Trial name
- NCT00633269
- Testing
- AZD2281
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- AstraZeneca
Mucopolysaccharidosis II, MPS II
Ascending Dose Study of Genome Editing by the Zinc Finger Nuclease (ZFN) Therapeutic SB-913 in Subjects With MPS II
The purpose of the study is to evaluate the safety, tolerability and effect on leukocyte and plasma Iduronate 2-Sulfatase (IDS) enzyme activity of ascending doses of SB-913.
- Trial name
- NCT03041324
- Testing
- SB-913
- Where
- 5 sites in United States
- Volunteers
- 9 people
- Sponsor
- Sangamo Therapeutics
Chronic Kidney Failure
Phase III Study to Investigate the Safety and Efficacy of Fermagate and Sevelamer Hydrochloride
Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb.
- Trial name
- NCT00844662
- Testing
- Fermagate, Sevelamer hydrochloride
- Where
- 109 sites in United States, Belgium and 13 more
- Volunteers
- 1,000 people
- Sponsor
- Ineos Healthcare Limited
Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2
Pilot Assessment of the Effects of Bardoxolone Methyl on Renal Perfusion, Systemic Haemodynamics and Cardiac Function in Patients With Chronic Kidney Disease and Type 2 Diabetes
This study is to evaluate the variability of several pharmacodynamic measures of kidney function, cardiovascular function, cerebral perfusion, and haemodynamics.
- Trial name
- NCT01551446
- Testing
- Bardoxolone Methyl
- Sponsor
- Biogen
Diabetes, Diabetic Retinopathy
Pivotal Trial of Automated Artificial Intelligence (AI) Based System for Early Diagnosis of Diabetic Retinopathy
In this pivotal trial, we aim to perform a prospective study to find the efficacy of iPredict-DR, an artificial intelligence (AI) based software tool on early diagnosis of Diabetic Retinopathy (DR) in the primary care and…
- Trial name
- NCT07151001
- Testing
- No intervention
- Where
- United States
- Volunteers
- 922 people, healthy volunteers welcome
- Sponsor
- iHealthScreen Inc
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and tolerability of CTAP101 will also be evaluated
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency
- Trial name
- NCT01651000
- Testing
- CTAP101 30 μg capsules, Sugar pill to CTAP101 30 μg capsules
- Where
- United States
- Volunteers
- 213 people
- Sponsor
- OPKO IP Holdings II, Inc.
Osteoporosis
Age Dependend Diagnostic Thresholds for Osteoporosis Bindex Ultrasonometer
This study is designed for clinical validation of the novel ultrasound device (Bindex®, Bone Index Finland Ltd.). In a preliminary study technique has been validated in Finnish elderly woman population with 285 healthy and 56…
- Trial name
- NCT01978834
- Where
- United States
- Volunteers
- 560 people, healthy volunteers welcome
- Sponsor
- Bone Index Finland Ltd
Diabetes Type 2, Hyperglycaemia (Diabetic)
Effect of Hyperglycaemia and Moxifloxacin on QTc Interval in T2DM
Diabetes is a significant risk factor for sudden cardiac death, with the QTc interval on electrocardiograms (ECGs) often prolonged in diabetic patients due to factors such as hyperglycaemia and insulin resistance.
- Conditions
- Diabetes Type 2, Hyperglycaemia (Diabetic), QT Interval, Variation in, Torsades de Pointes
- Trial name
- NCT07014735
- Testing
- glucose, moxifloxacin
- Where
- United Kingdom
- Volunteers
- 14 people
- Sponsor
- Richmond Pharmacology Limited
Anemia, Iron-Deficiency, Kidney Failure, Chronic
Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents
This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are receiving erythropoietic agents…
- Trial name
- NCT00224042
- Testing
- Sodium Ferric Gluconate complex in sucrose, Ferrous sulfate tablets
- Where
- 24 sites in United States, Puerto Rico
- Volunteers
- 52 people
- Sponsor
- Watson Pharmaceuticals
Diabetes, Ulceration
Shear and Pressure Reducing Insoles for the Diabetic Foot
We evaluated the feasibility of the GlideSoft™ novel insole to reduce pressure and shear forces on the foot. No commercially available insoles are designed to reduce shear.
- Conditions
- Diabetes, Ulceration, Amputation, Foot Deformity
- Trial name
- GlideSoft (NCT00499356)
- Testing
- pressure reducing insole, GlideSoft®
- Where
- United States
- Volunteers
- 299 people
- Sponsor
- Diabetica Solutions Inc.