Clinical trials: Hormone Replacement
Primary Immune Deficiency Disorder
Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
The objective of this study is to assess the long-term safety, tolerability, and efficacy of IgPro20 in subjects with primary immunodeficiency (PID) as a follow-up to the pivotal study ZLB06_002CR (NCT01199705).
- Trial name
- NCT01458171
- Testing
- Immune globulin subcutaneous (Human)
- Where
- 9 sites in Japan
- Volunteers
- 23 people
- Sponsor
- CSL Behring
Cigarette Smoking, Smoking Cessation
Goal2Quit + NRT Sampling
The goal of this work is to develop, systematically evaluate, and clinically test an integrated cessation intervention comprised of a depression-specific Behavioral Activation (BA) for cessation mobile app ("Goal2Quit") packaged…
- Conditions
- Cigarette Smoking, Smoking Cessation, Depression
- Trial name
- NCT03837379
- Testing
- Treatment as Usual, Goal2Quit + NRT Sampling
- Where
- United States
- Volunteers
- 164 people
- Sponsor
- Medical University of South Carolina
Spinal Cord Injury, Spinal Cord Injuries
Testosterone Plus Finasteride Treatment After Spinal Cord Injury
The purpose of this study is to determine whether testosterone plus finasteride treatment will improve musculoskeletal health, neuromuscular function, body composition, and metabolic health in hypogonadal men who have experienced…
- Conditions
- Spinal Cord Injury, Spinal Cord Injuries, Trauma, Nervous System, Wounds and Injuries
- Trial name
- NCT02248701
- Testing
- Testosterone Enanthate, Finasteride
- Where
- 2 sites in United States
- Volunteers
- 33 people
- Sponsor
- VA Office of Research and Development
MPS IV A
A Double-Blind Study to Evaluate the Efficacy and Safety of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome)
This Phase 3 study will evaluate the efficacy and safety of 2.0 mg/kg/week BMN 110 and 2.0 mg/kg/every other week BMN 110 in patients with mucopolysaccharidosis IVA (Morquio A Syndrome).
- Trial name
- NCT01275066
- Testing
- BMN 110 Weekly, BMN 110 Every Other Week
- Where
- 28 sites in United States, Argentina and 15 more
- Volunteers
- 177 people
- Sponsor
- BioMarin Pharmaceutical
Tobacco Use Cessation, Smoking Cessation
Treating Low-Income Smokers in the Hospital Emergency Department
This study will test the effectiveness of an Emergency Department (ED) initiated tobacco intervention which includes counseling and medication.
- Conditions
- Tobacco Use Cessation, Smoking Cessation, Smoking, Tobacco Use Disorder
- Trial name
- NCT01328431
- Testing
- Brief Intervention with NRT Initiation
- Where
- United States
- Volunteers
- 780 people
- Sponsor
- Yale University
Smoking Cessation
Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations
The primary objective of this study is to compare pharmacokinetic (PK) profiles and assess the bioequivalence between the newly developed nicotine gums (2 mg and 4 mg) and the reference nicotine gums (2 mg and 4 mg) in healthy…
- Trial name
- NCT01847443
- Testing
- Nicotine (2 mg), Nicotine (4 mg)
- Where
- United Kingdom
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Menopause, Bone Demineralization
A Study to Learn More About the Menopausal Hormone Therapies in Korea
The purpose of this study is to learn about how the commonly used menopausal hormone therapies were prescribed and taken in practice.
- Trial name
- NCT06033521
- Testing
- Menopausal hormone therapy Intervention Type: Drug
- Where
- South Korea
- Volunteers
- 1,036,294 people
- Sponsor
- Pfizer
Growth Hormone Deficiency, Pediatric, Endocrine System Diseases
A Safety, Tolerability and Efficacy Study of TransCon hGH in Children With Growth Hormone Deficiency
A 26 week trial of TransCon hGH, a long-acting growth hormone product, administered once-a-week. Approximately 150 children (males and females) with growth hormone deficiency (GHD) will be included.
- Conditions
- Growth Hormone Deficiency, Pediatric, Endocrine System Diseases, Hormone Deficiency, Pituitary Diseases
- Trial name
- NCT03305016
- Testing
- TransCon hGH
- Where
- 24 sites in United States, Australia and 2 more
- Volunteers
- 146 people
- Sponsor
- Ascendis Pharma Endocrinology Division A/S
Endothelial Dysfunction
Impact of Smoking Cessation and γ-Tocopherol to Restore Vascular Endothelial Function
Cigarette smoking is a significant risk factor for cardiovascular disease (CVD) and is the leading cause of premature mortality in the US.
- Trial name
- NCT01314443
- Testing
- Nicotine Replacement Therapy (NRT), Gamma-Tocopherol, Smoking cessation
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- University of Connecticut
Adult Growth Hormone Deficiency, Endocrine System Diseases
A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency
This was a phase 3 open-label multicenter extension study designed to evaluate the long-term safety and efficacy of Lonapegsomatropin administered once-weekly.
- Conditions
- Adult Growth Hormone Deficiency, Endocrine System Diseases, Hormone Deficiency
- Trial name
- NCT05171855
- Testing
- Lonapegsomatropin
- Where
- 85 sites in United States, Armenia and 19 more
- Volunteers
- 220 people
- Sponsor
- Ascendis Pharma Endocrinology Division A/S
Iron Deficiency Anaemia, Iron Deficiency Anemia
Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
The trial was designed to evaluate the incidence of unintended hypophosphatemia (low level of phosphate in the blood) in subjects with iron deficiency anaemia (IDA).
- Trial name
- NCT03237065
- Testing
- Iron isomaltoside/ferric derisomaltose, Ferric carboxymaltose
- Where
- 15 sites in United States
- Volunteers
- 122 people
- Sponsor
- Pharmacosmos A/S
Gaucher Disease, Type 1
An Open-Label Extension Study of GA-GCB ERT in Patients With Type 1 Gaucher Disease
The purpose of this study is to evaluate the long-term safety of every other week dosing of Gene-Activated® human glucocerebrosidase (GA-GCB, velaglucerase alfa) intravenously in patients with type 1 Gaucher disease.
- Trial name
- NCT00635427
- Testing
- VPRIV®
- Where
- 21 sites in United States, Argentina and 9 more
- Volunteers
- 95 people
- Sponsor
- Shire
Klinefelter Syndrome, XXY Syndrome
Study of Psychological and Motor Effects of Testosterone in Adolescents With XXY/Klinefelter Syndrome
The purpose of this study is to determine if testosterone replacement therapy leads to changes in psychological factors and/or motor skills in adolescent males with 47,XXY (also called Klinefelter syndrome).
- Trial name
- TestoXXY/KS (NCT01585831)
- Testing
- Testosterone gel 1%
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- University of Colorado, Denver
Hunter Syndrome
An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment
This extension study of HGT-HIT-045 is designed to collect long-term safety data in pediatric participants with Hunter syndrome and cognitive impairment who are receiving intrathecal (IT) idursulfase-IT and intravenous (IV)…
- Trial name
- NCT01506141
- Testing
- Idursulfase-IT, Elaprase
- Where
- 9 sites in United States, Canada and 1 more
- Volunteers
- 15 people
- Sponsor
- Takeda
Spinal Muscular Atrophy
Safety and Efficacy of Intravenous OAV101 (AVXS-101) in Pediatric Patients With Spinal Muscular Atrophy (SMA)
To evaluate the safety, tolerability and efficacy of intravenous administration of OAV101 (AVXS-101) in patients with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene weighing ≥…
- Trial name
- SMART (NCT04851873)
- Testing
- OAV101
- Where
- 13 sites in United States, Australia and 7 more
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
Hyperuricemia
Lowering Serum Uric Acid to Prevent Acute Kidney Injury
Acute kidney injury is associated with a rise in serum uric acid during cardiovascular surgery and can cause poor blood flow to the kidneys making them vulnerable to kidney injury.
- Trial name
- RasbAKI (NCT00756964)
- Testing
- Rasburicase
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- University of Florida
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
Mucopolysaccharidosis I
Immune Tolerance Study With Aldurazyme® (Laronidase)
The purpose of this study is to see if treatment with an antigen-specific immunosuppressive can decrease or stop an antibody response to laronidase (Aldurazyme®) during enzyme replacement therapy with laronidase in severe…
- Trial name
- NCT00741338
- Testing
- Laronidase, Cyclosporine A (CsA), Azathioprine (Aza)
- Where
- 2 sites in Brazil, Russia
- Volunteers
- 7 people
- Sponsor
- Genzyme, a Sanofi Company
Septic Shock
Albumin Replacement Therapy in Septic Shock
Albumin is a key regulator of fluid distribution within the extracellular space and possesses several properties beyond its oncotic activity, including binding and transport of several endogenous molecules, anti-inflammatory and…
- Trial name
- ARISS (NCT03869385)
- Testing
- Albutein® 200 g/L or Plasbumin® 20
- Where
- 27 sites in Germany
- Volunteers
- 440 people
- Sponsor
- Jena University Hospital
Hypophosphatasia
Study of ALXN1850 in Participants With Hypophosphatasia (HPP)
This is an open-label, dose-escalating study to assess safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity of ALXN1850 when given intravenous (IV) and subcutaneous (SC) to adults with HPP.
- Trial name
- NCT04980248
- Testing
- ALXN1850
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Alexion Pharmaceuticals, Inc.