Clinical trials: Hormone Replacement Therapy
Fabry Disease
A Multicenter Open-Label Treatment Protocol to Observe the Safety of Replagal (Agalsidase Alfa) Enzyme Replacement Therapy in Canadian Patients With Fabry Disease
The purpose of this study is to observe the safety of agalsidase alfa in Canadian patients with Fabry disease.
- Trial name
- NCT01298141
- Testing
- agalsidase alfa
- Where
- 12 sites in Canada
- Volunteers
- 171 people
- Sponsor
- Shire
Smoking
Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 (THS 2.2)
The overall goal of the study is to evaluate the pharmacokinetic (PK) profile (rate and the amount of nicotine absorbed) following a single use of the THS 2.2, a candidate Modified Risk Tobacco Product, compared to the PK…
- Trial name
- NCT01959607
- Testing
- THS 2.2, CC, NRT Gum
- Where
- Japan
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Smoking
Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol).
The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile (rate and amount of nicotine absorbed) following a single use of the THS 2.2 Menthol (mTHS), a candidate Modified Risk Tobacco Product…
- Trial name
- NCT01967706
- Testing
- mTHS, mCC, NRT
- Where
- Japan
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Replacement Therapy, Renal
Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED)
In a prospective, non-interventional, monocentric observational study the pharmacokinetic properties of selected antiinfective drugs during sustained low-efficiency dialysis (SLED) will be analyzed.
- Trial name
- PhA-SLED (NCT02287493)
- Testing
- Pharmacokinetic Analysis
- Where
- Germany
- Volunteers
- 35 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Fabry Disease
Safety and Efficacy of PRX-102 in Patients With Fabry Disease Currently Treated With REPLAGAL® (Agalsidase Alfa)
This is an open label switch over study to assess the safety and efficacy of PRX-102 (pegunigalsidase alfa). Patients treated with agalsidase alfa for at least 2 years and on a stable dose (>80% labelled dose/kg) for at least 6…
- Trial name
- NCT03018730
- Testing
- PRX-102 (pegunigalsidase alfa)
- Where
- 9 sites in Australia, Canada and 5 more
- Volunteers
- 22 people
- Sponsor
- Protalix
Spinal Muscular Atrophy Type I
Single-Dose Gene Replacement Therapy Using for Patients With Spinal Muscular Atrophy Type 1 With One or Two SMN2 Copies
This is a Phase 3, open-label, single-arm, single-dose, trial of onasemnogene abeparvovec-xioi (gene replacement therapy) in participants with spinal muscular atrophy (SMA) Type 1 and who are genetically defined by a biallelic…
- Trial name
- NCT03837184
- Testing
- Onasemnogene Abeparvovec-xioi
- Where
- 4 sites in Japan, South Korea and 1 more
- Volunteers
- 2 people
- Sponsor
- Novartis Gene Therapies
Smoking
Phase I Study: Stop Smoking Therapy for Ontario Patients (STOP)
20% of Ontarians smoke. There was a decline in smoking prevalence from 1995 but it has remained unchanged since 2002. This rate of smoking cessation has not kept up with the rest of Canada.
- Trial name
- NCT00356993
- Testing
- Nicotine Replacement Therapy, behavioural intervention
- Where
- Canada
- Volunteers
- 6,009 people
- Sponsor
- Centre for Addiction and Mental Health
Lysosomal Acid Lipase Deficiency
Safety and Efficacy Study of Sebelipase Alfa in Participants With Lysosomal Acid Lipase Deficiency
This study evaluated the safety and efficacy of sebelipase alfa in a broad population of participants with lysosomal acid lipase deficiency (LAL-D).
- Trial name
- NCT02112994
- Testing
- Sebelipase Alfa
- Where
- 19 sites in United States, Australia and 13 more
- Volunteers
- 31 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Glaucoma
AZARGA Transition Study in Taiwan for Patients With Uncontrolled Intraocular Pressure
The purpose of this study was to assess the safety and efficacy of switching to Azarga from prior pharmacotherapy in patients with open-angle glaucoma.
- Trial name
- NCT01484951
- Testing
- Brinzolamide 1% and timolol 0.5% fixed combination eye drops
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- Alcon Research
Open-Angle Glaucoma, Ocular Hypertension
Efficacy of Changing to DUOTRAV® From Prior Therapy
The purpose of this study was to assess the efficacy and tolerability of changing to DUOTRAV® from prior bimatoprost 0.03%/timolol 0.5% pharmacotherapy in subjects with open-angle glaucoma or ocular hypertension having…
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension, Pigment Dispersion Glaucoma
- Trial name
- NCT01327599
- Testing
- Travoprost 0.004%+Timolol 0.5% ophthalmic solution
- Volunteers
- 60 people
- Sponsor
- Alcon Research
Myocardial Ischemia
Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study
The goal of the main trial was to evaluate the effect of low dose hormone replacement therapy with 1 mg norethindrone/10mcg ethinyl estradiol in postmenopausal women with a history of chest discomfort, myocardial ischemia and no…
- Trial name
- NCT00600106
- Testing
- 1/10 NA/EE
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Cedars-Sinai Medical Center
Chronic Kidney Disease
Empowering Patients On Choices for Renal Replacement Therapy (Aim 3) (EPOCH-RRT)
Empowering Patients On Choices for Renal Replacement Therapy (EPOCH-RRT) study seeks to identify factors that matter the most to patients with kidney disease and study how they are impacted by different types of dialysis.
- Trial name
- EPOCH-RRT (NCT02488317)
- Testing
- Decision Aid
- Where
- United States
- Volunteers
- 234 people
- Sponsor
- Arbor Research Collaborative for Health
Growth Hormone Deficiency, Pediatric, Endocrine System Diseases
A Long-Term Trial Investigating Safety and Efficacy of TransCon hGH in Children With Growth Hormone Deficiency Who Have Completed a Prior TransCon hGH Clinical Trial
A multicenter, phase 3, long-term extension trial of TransCon hGH administered once-weekly in children with growth hormone deficiency (GHD) who previously participated in a phase 3 TransCon hGH trial.
- Conditions
- Growth Hormone Deficiency, Pediatric, Endocrine System Diseases, Hormone Deficiency, Pituitary Diseases
- Trial name
- enliGHten (NCT03344458)
- Testing
- TransCon hGH
- Where
- 42 sites in United States, Armenia and 9 more
- Volunteers
- 298 people
- Sponsor
- Ascendis Pharma A/S
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
The primary objectives of this study are to assess the safety and efficacy of MS1819-SD vs porcine pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).
- Trial name
- OPTION (NCT03746483)
- Testing
- MS1819, Porcine PERT
- Where
- 14 sites in United States, Poland
- Volunteers
- 41 people
- Sponsor
- Entero Therapeutics
Anorexia Nervosa
Adrenal and Gonadal Hormone Replacement in Anorexia Nervosa
This study seeks to gain new information on why young women with anorexia nervosa are predisposed to early bone loss and osteoporosis.
- Trial name
- NCT00310791
- Testing
- Hormone replacement therapy (estrogen/progestin), Dehydroepiandrosterone (DHEA)
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Boston Children's Hospital
HIV, Opioid Dependence
Testing a Community-Friendly Risk Reduction Intervention for Injection Drug Users
To conduct a randomized clinical trial (RCT) of a community-friendly behavioral intervention designed to reduce HIV risk behavior among injection drug users (IDUs) in drug treatment by comparing risk-behavior outcomes of four…
- Trial name
- NCT01741350
- Testing
- Community-friendly Health Recovery Program, Time-and-Attention-Matched Control Condition
- Where
- United States
- Volunteers
- 304 people
- Sponsor
- University of Connecticut
Growth Hormone Deficiency, Traumatic Brain Injury
Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
Fifteen to twenty percent of adults who suffer a traumatic brain injury (TBI) that requires hospitalization and rehabilitation have been found to have growth hormone (GH) deficiency by GH stimulation testing.
- Trial name
- NCT00957671
- Testing
- Recombinant human growth hormone
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- The University of Texas Medical Branch, Galveston
Perimenopausal Disorder, Depression
Effects of a Tissue Selective Estrogen Complex (TSEC) on Depression and the Neural Reward System in the Perimenopause"
Using neuroimaging, the investigator will study the effects of estrogen on mood and brain function in perimenopausal women with depression.
- Trial name
- Duavee (NCT03740009)
- Testing
- Bazedoxifene/Conjugated Estrogen
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Acute Kidney Injury
Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI).
The SCD (Selective Cytopheretic Device) is an extracorporeal device used as an adjunct to renal replacement therapy (RRT) to improve the outcomes of pediatric patients with acute kidney injury (AKI).
- Trial name
- SCD-PED-01 (NCT02820350)
- Testing
- SCD-F40
- Where
- 4 sites in United States
- Volunteers
- 19 people
- Sponsor
- CytoPherx, Inc
Hunter Syndrome, Mucopolysaccharidosis II
Safety and Clinical Outcomes in Hunter Syndrome Patients 5 Years of Age and Younger Receiving Idursulfase Therapy
The objective of this study is to determine the safety of once weekly dosing of idursulfase 0.5 mg/kg administered by intravenous (IV) infusion for male Hunter syndrome patients ≤ 5 years old.
- Conditions
- Hunter Syndrome, Mucopolysaccharidosis II, MPS II
- Trial name
- NCT00607386
- Testing
- Idursulfase
- Where
- 3 sites in Brazil, Poland and 1 more
- Volunteers
- 28 people
- Sponsor
- Shire